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Science, Technology and Medicine open access publisher.Publish, read and share novel research. Effectiveness of Fenugreek for Lowering Hemoglobin (HbA1c) in Patients with Self-Management of Type 2 Diabetes: A Randomized Controlled TrialRashid Ansari1 and Saiqaa Ansari2[1] School of Public Health, University of New England, Australia[2] School of Population Health, University of Queensland, Australia1. L'obesite est devenue un probleme majeur de sante publique, en particulier dans les pays industrialises. La masse adipeuse represente normalement de 10 a 15 % du poids total chez l'homme, de 20 a 25 % chez la femme. La valeur dite de « poids ideal », qui servait autrefois de reference pour definir le surpoids et l'obesite, n'est plus usitee aujourd'hui. L'expansion du tissu adipeux peut etre liee a une augmentation des cellules adipeuses soit en taille (obesite hypertrophique), soit en nombre (obesite hyperplasique) ; les obesites morbides sont a la fois hypertrophiques et hyperplasiques. Les obesites androides ou abdominales, ou la graisse predomine a la partie haute du corps et sur l'abdomen, sont typiques de l'obesite masculine, mais s'observent egalement chez certaines femmes. Parmi les cas d'obesite abdominale, on distingue depuis quelques annees l’obesite dite « viscerale », caracterisee par une augmentation de la graisse a l'interieur de l'abdomen, autour des visceres.
Les obesites gynoides ou femorales, ou la graisse predomine a la partie basse du corps (fesses, cuisses), sont caracteristiques de l'obesite feminine. L'exces de masse grasse s'observe lorsque les apports d'energie alimentaire sont plus eleves que les depenses energetiques (bilan d'energie positif) et lorsque divers processus metaboliques et hormonaux favorisent le stockage des graisses (lipides) aux depens de la synthese des proteines et de l'accroissement de la masse maigre (bilan lipidique positif).
En effet, la transmission familiale de l'obesite est a distinguer d'une eventuelle transmission genetique (qui n'est, elle, pas completement demontree). Les troubles du comportement alimentaire : pour devenir obese, il ne suffit pas d'y etre predispose, il faut aussi manger trop par rapport a ses depenses energetiques, ou trop gras par rapport a ses capacites d'oxydation des graisses. Facteurs psychologiques, comportementaux et psychosociaux : la depression, l'angoisse, l'anxiete (decoulant, par exemple, d'un choc affectif ou d'un stress) entrainent souvent, par compensation, une tendance a trop manger ou a diminuer son niveau d'activite. Les risques les plus graves sont les accidents cardiovasculaires, qui concernent plus les sujets atteints d'obesite androide ou mixte que les sujets atteints d'obesite gynoide, plus les hommes que les femmes, et particulierement les sujets hypertendus, diabetiques et hyperlipidemiques. Les risques n'etant cependant pas les memes pour tous les sujets obeses, ce qui est valable a l'echelle d'une population ne l'est pas necessairement pour un individu. Le traitement de l'obesite repose sur la reduction de l'exces de poids par un regime associee a une augmentation de l’activite physique ; lorsque l'obesite est due a une maladie, celle-ci doit etre soignee. Les regimes tres severes, sources d'amaigrissement rapide, ne donnent pas a long terme de resultats satisfaisants. Les etudes montrent que la reprise de poids est souvent superieure a la perte (effet « yoyo »). Au fils des ans et des regimes restrictifs, la prise de poids finale peut aboutir a une veritable obesite majeure ou morbide qui devient de plus en plus difficile a supporter physiquement et moralement. Voir : boulimie, chirurgie bariatrique, depense energetique, poids corporel, ration alimentaire, syndrome de Bardet-Biedl, court-circuit gastrique, gastroplastie, liposuccion, regime.
Dans la plupart des civilisations traditionnelles, etre gros est signe de prosperite et de richesse.
The Diabetes Education and Self-Management Program’s team combines the patient, family, physician, registered nurse, and dietitian. Individuals with a higher than normal blood glucose level but do not yet meet criteria to be diagnosed with diabetes are at a higher risk for developing diabetes, a term described as pre-diabetes. Focus on nutritious foods like fruits, vegetables, whole grains and low fat dairy, rather than high fat goods such as ice cream, donuts, chips, and cream based sauces. Physical activity and exercise are important in both the prevention and treatment of diabetes.
When you have diabetes, your body can't properly use and store glucose (sugar) which results in a build-up of too much sugar or glucose. Most insurance companies, including Medicare and Medicaid, will assist you in the cost of diabetes education.
Enfermedad que se caracteriza por alta concentracion de glucosa o azucar en sangre, debido a la incapacidad del organismo para aprovecharla. En condiciones normales, la glucosa que ingresa a traves de los alimentos es utilizada por tejido adiposo (que almacena grasa) y musculos gracias a la insulina, hormona producida por el pancreas que hace que el azucar llegue a las celulas y se emplee como fuente de energia. Al presentarse diabetes mellitus tipo 2, el cuerpo no responde al estimulo de la insulina, de modo que los tejidos no permiten el paso de la glucosa.
Comenta el tema o, si tienes alguna consulta medica, da clic aqui y los especialistas de la seccion Pregunta al Medico responderan tus dudas. Si tienes alguna consulta medica, da clic aqui y los especialistas de la seccion Pregunta al Medico responderan tus dudas. Les amandes, pourtant reputees caloriques, sont des alliees de choix contre les bourrelets et le diabete. L’ongle incarne est issu d’un conflit douloureux entre le bord lateral de l’ongle et le bourrelet de l’orteil. Les lamelles en resine polymerisee modifient l’hyper courbure de l’ongle et soulagent la zone de conflit. Ces differents traitements sont d’autant plus efficaces et indolores s’ils sont effectues precocement.
En cas d’echec de ces differents traitements (5% des cas), le recours a la chirurgie est preconise.
IntroductionThe incidence of type 2 diabetes is increasing worldwide, resulting in large measure from the increasing prevalence of obesity (Yale, 2000). De plus en plus repandue et souvent grave, elle predispose a nombre de maladies, diminue l'esperance de vie et entraine des depenses de soins et de prevention croissantes.
On parle d'obesite lorsqu'elle atteint plus de 20 % du poids total chez l'homme, plus de 30 % chez la femme.
Cette notion est en effet trop artificielle et ne tient compte ni de l'age, ni des variations ethniques, ni plus generalement d'aucun des divers facteurs pouvant moduler le poids physiologiquement normal d'un individu. On reconnait des obesites a debut infantile, dites obesites « constitutionnelles », souvent massives, et des obesites a debut adulte, dites obesites « acquises ». C’est la forme d’obesite la plus dangereuse et la plus critique en termes de risques metaboliques et cardiovasculaires. Elles peuvent entrainer des douleurs articulaires ou des troubles de la circulation veineuse, mais rarement des complications cardiovasculaires ou metaboliques. De tels bilans energetiques ou lipidiques positifs peuvent etre atteints de differentes manieres, ce que suggere l'heterogeneite clinique du symptome de l'obesite.
Differents aspects du metabolisme et du comportement susceptibles de predisposer l'individu a devenir obese sont egalement tres probablement d'origine genetique, comme sa capacite a oxyder les graisses ou a les stocker, son adaptabilite aux changements d'environnement alimentaire, ses preferences gustatives, etc. Outre l'aspect genetique, les membres d'une meme famille partagent en effet un mode de vie et d'alimentation, un contexte socioculturel, qui peuvent, aussi bien que l'heredite, expliquer la transmission familiale de l'obesite. Cet exces de nourriture est favorise par l'abondance, la variete, la nature des aliments disponibles, mais egalement par les habitudes familiales et sociales et les conditionnements culturels, qui donnent a l'aliment une dimension affective et symbolique et conduisent a manger sans faim ou au-dela de la satiete. De surcroit, l'obesite elle-meme, par ses consequences psychologiques et les comportements de restriction inconsideres qu'elle peut entrainer, suscite souvent son auto-entretien ou son aggravation.
Le risque de cancer (prostate et colon chez l'homme, uterus, seins, ovaires chez la femme, voies biliaires chez les individus des deux sexes) est majore. Tout regime doit etre elabore par un medecin qui effectuera un bilan clinique, fera une evaluation aussi precise que possible des apports alimentaires habituels du sujet et prescrira au besoin certains examens (bilan sanguin, dosages hormonaux). Ainsi, une perte de poids meme modeste s'accompagne generalement d'une reduction de la tension arterielle, des lipides du sang, d'une amelioration de la tolerance au glucose et de la sensibilite a l'insuline. Les insucces du traitement ont donne lieu a une infinite de regimes fantaisistes, presentes comme magiques, mais pour la plupart inefficaces et dangereux. En cas d’echec des regimes et du manque d’effets d’une augmentation de l’activite physique, un traitement medicamenteux peut etre propose par le medecin. En cas d'obesite severe ou morbide, diverses techniques chirurgicales (chirurgie bariatrique) modifiant le tractus digestif (notamment l'estomac) et visant a limiter de facon permanente l'alimentation peuvent etre pratiquees. The education department focuses on the AADE7 Self Care Behaviors, which include: healthy eating, being active, monitoring, taking medications, problem solving, healthy coping, and reducing risks. Without treatment, it can result in serious health problems, including cardiovascular disease, which is the leading cause of morbidity and mortality in people with diabetes, but you can learn to manage diabetes and live a healthier life.
The goal is to engage in 150 minutes per week of moderate intensity physical activity, such as walking or cycling. Como resultado, esta aumenta su concentracion en la sangre.Sin tratamiento, el azucar excedente afecta la vision y el funcionamiento de los rinones, dana a nervios y paredes de venas y arterias, y predispone infartos. Selon une etude presentee au 11e Congres international sur l’obesite a Stockholm, consommer 30 g d’amandes au petit dejeuner facilite le maintien d’un bon niveau d’insuline, ce qui contribue a combattre le diabete de type 2. D’abord intermittente elle devient ensuite systematique au chaussage lorsque le phenomene prend une tournure inflammatoire.
Diabetes mellitus is a pandemic disease and is one of the main threats to human health (Narayan, 2005).
Certaines personnes obeses presentent manifestement des troubles de conduite alimentaire, d'autres non.
L’obesite abdominale est definie actuellement par la mesure du tour de taille, superieur a 88 cm chez la femme (hors grossesse) et superieur a 102 cm chez l’homme. Celle-ci semble resulter de l'association, en proportions variables, et de l'interaction de perturbations diverses tirant leur origine de facteurs genetiques comportementaux et environnementaux (alimentation). Hormis certains cas d’obesites massives tres rares, il n’existe pas un gene unique conduisant a l’obesite mais plusieurs genes dont la combinaison avec un environnement favorisant la prise de poids est responsable de l’inflation du tissu adipeux.
Les genes impliques sont tres nombreux et seulement une infime partie a ete identifiee ; les genes identifies a l’heure actuelle sont responsables de formes d’obesites tres rares.
Enfin, l'evolution du mode de vie s'est traduite par une augmentation de la consommation de graisses et de sucres cependant que les acquis du confort moderne (ascenseurs, transports, chauffage) contribuent a diminuer l'exercice physique et les autres depenses energetiques. L'agression psychologique peut aussi provoquer une obesite en dereglant le systeme neurohormonal, qui controle notamment le metabolisme des graisses.
Surtout chez la femme et quel que soit l'age, l'obesite augmente la frequence des calculs biliaires et aggrave l'arthrose des genoux et des hanches, ce qui renforce la sedentarite. Le regime prescrit (avec la participation eventuelle d'un dieteticien) sera le plus souvent hypocalorique, mais avec un apport proteinique (viande, poisson, ?uf, produits laitiers) suffisant pour eviter une fonte des masses maigres (muscles, notamment) ; il proposera une reduction importante des produits et des boissons sucres, une reduction des apports en autres glucides (cereales, feculents, fruits) et en lipides (corps gras, aliments les plus gras) ainsi qu'une diminution importante des boissons alcoolisees. Dans la mesure ou il est encore difficile de soigner les causes de l'obesite, le traitement de celle-ci reste malaise et requiert une prise en charge et un suivi a long terme ainsi que la participation active du patient ; il vise avant tout a prevenir les rechutes, qui sont frequentes.
Chez ces personnes, chaque regime hypocalorique stimule les facultes de stockage du moindre apport calorique, un processus tres actif lors du retour a une alimentation normale. Un medicament est autorise actuellement en France pour traiter les personnes obeses : l’orlistat, un inhibiteur de la lipase intestinale qui s’oppose a l’absorption des graisses. En revanche, dans les pays industrialises, il y a de plus en plus d'obeses et l'obesite est plus repandue dans les milieux socio-economiques defavorises.
Tales consecuencias pueden evitarse con diagnostico oportuno y siguiendo el tratamiento adecuado, que consiste, basicamente, en llevar dieta saludable, practicar ejercicio con regularidad y, cuando se requiere, tomar medicamentos o aplicar insulina. Elles favorisent la satiete, qui aide a eviter les grignotages intempestifs, et cerise sur le gateau, leurs fibres contribueraient a ralentir l’absorption de calories.
A ce stade le patient constate souvent que la douleur est reveillee la nuit par le poids du drap sur l’orteil.


Pour certains sujets, une circonstance declenchante nette peut etre reperee, suivie d'une prise de poids rapide ; chez d'autres, l'obesite se constitue tres progressivement au fil des ans. L'obesite est un facteur de risque dans diverses affections : insuffisances coronarienne et cardiaque, hypertension arterielle, diabete, goutte, hyperlipidemies (taux sanguin de lipides excessif), lithiase biliaire, insuffisance respiratoire, apnees du sommeil, maladies rhumatologiques, etc. Reparti en trois ou quatre prises journalieres, le regime doit etre le plus equilibre possible et comprendre des aliments de tous les groupes. L'alternance de phases d'amaigrissement suivies de phases de reprise de poids est en effet plus dangereuse pour la sante que l'absence de regime. C’est probablement ce mecanisme qui a permis a nos ancetres dotes de cette capacite de survivre entre deux periodes successives de disette ou de famine que le regime reproduit. Ce medicament doit etre prescrit par un medecin ; il n'est pas efficace dans tous les cas et presente des effets secondaires. En l’absence de traitement, il va y avoir apparition d’un phenomene infectieux, douloureux en continu. It is projected that this number will be increased by 72% to 333 million by 2025, and nearly 80% of these cases will be in the poorer industrialized countries (IDF, 2003). On peut l’evaluer de maniere approximative par la mesure du tour de taille (qui definit l’obesite abdominale).
Schematiquement, les obesites androides presentent davantage de complications de type metabolique (diabete, hypertension, insuffisance cardiaque, insuffisance respiratoire, syndrome d’apnee du sommeil), alors que les obesites gynoides presentent davantage de complications rhumatologiques et veineuses (arthrose, phlebites). Le poids a atteindre et la duree du traitement font l'objet d'un contrat prealable entre le patient et le praticien, revisable en cours de traitement.
Le seul moyen d’y echapper est de ne jamais faire de regime hypocalorique et de maigrir en augmentant son activite physique tout en ayant une alimentation sans exces, mais suffisante.
Working closely with your healthcare team to manage your diabetes can lessen your risks of long term complications from diabetes, Remember, as your life changes, your plan will need to change too. According to a 2005 US Government estimate, approximately 21 million people in the United States have diabetes (Gerich, 2005).
In 2002, diabetes was the sixth leading cause of death and had an estimated total cost of $132 billion (Hogan et al.
Type 2 diabetes is a disease characterized by a dual defect: 1) by insulin resistance which prevents cells from using insulin properly, and 2) degrees of reduced pancreatic insulin secretion. L'obesite ne peut etre efficacement combattue que si l'on prend en compte a la fois ses dimensions biologiques, psychologiques et sociales.On sous-estime souvent les complications psychosociales de l'obesite, qui induit rejet social, discriminations, prejudices economiques. A quarter of the population of Pakistan would be classified as overweight or obese with the use of Indo-Asian-specific BMI cutoff values. La culpabilite et la depression qui en resultent sont autant de facteurs autoaggravants de l'obesite. Jafar et al (2006) have reported that prevalence of overweight was 25% and obesity was 10% in a large population-based sample of people over the age of 15 years in Pakistan.
L'ideal de minceur entraine des restrictions alimentaires abusives, sources de troubles du comportement alimentaire, lesquels favorisent en retour la prise de poids. On the age-specific prevalence of overweight and obesity, they found that more than 40% of women and 30% of men aged 35–54 years were classified as overweight or obese. S'il est obtenu par des mesures draconiennes, l'amaigrissement peut etre generateur de troubles psychologiques comme la depression. It has been suggested in a variety of observational and epidemiological studies that physical activity may play a significant role in the prevention of type 2 diabetes mellitus. The relationships between physical activity and overweight are only beginning to be understood for the adult population, sedentary behaviours, particularly watching television (TV) and videos, surfing the internet have been found to be related to higher body mass index (BMI) for adult’s population (Struber, 2004).
The literature linking physical activity levels with risk of overweight in adults is not consistent but physical activity is an important component of effective obesity treatments (Saelens, 2003). The main health promotion intervention here is the public health education which highlights the importance of physical activity for the prevention of type 2 diabetes in the middle-aged population of sub-continent and particularly Pakistan, which is experiencing a rapid and substantial decline of physical activity levels as a result of poor eating habits, unhealthy food supply, expansion of television, computerization, and mechanization, more prevalent car ownership and sedentary behaviour.
In parallel with decreasing levels of physical activity, the prevalence of overweight and obesity has increased significantly in Pakistan and as a consequence, diabetes mellitus has become a major public health issue.
Therefore, promoting an active lifestyle or regular exercise has become the highest public health priority in that country to overcome the onslaught of type 2 diabetes.
Also, the search for dietary adjuncts along with usual medical care to treat this life altering disease has become more important and dietary supplements that can modulate glucose homeostasis and potentially improve lipid parameters would be desirable.
Fenugreek (Trigonella foenum-graecum Linn) is a dietary supplement that may hold promise in this regard and is one of the oldest medicinal plants, originating in India and Northern Africa and dating back to ancient Egyptian times (Jensen, 1992).In Pakistan and India, fenugreek is commonly consumed as a condiment (Yoshikawa et al.
Fenugreek seeds also lower serum triglycerides, total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C) (Al-Habori and Raman, 1998). The lipid-lowering effect of fenugreek might also be attributed to its estrogenic constituent, indirectly increasing thyroid hormones (Basch, 2003). The plant protein in fenugreek is 26%, so it might exert a lipid lowering effect (Sharma, 1986). Since a high proportion of diabetic patients in sub-continent suffer from malnutrition, the use of fenugreek which is rich in protein and fiber (48%), has a distinct advantage in these patients (Sharma, 1986). This chapter addresses the effectiveness of fenugreek for lowering hemoglobin (HbA1c) in this randomized controlled trial and determines whether the intervention of taking fenugreek in combination of usual medical care lowers HbA1c in patients with type 2 diabetes.
Effectiveness trials such as this are critical in determining if the interventions are effective in the practical world in which patients live.
This randomized control trial addresses the research question “Is Fenugreek treatment with medical care for patients with type 2 diabetes more effective than usual medical care and can it help to lower the haemoglobin in patients with poorly controlled type 2 diabetes”? Characteristics of type 2 diabetesType 2 diabetes is associated with certain ethnic groups, obesity, family history of diabetes, and physical inactivity, among other factors. Chronic, untreated hyperglycemia can lead to serious complications that include cardiovascular diseases, blindness, kidney failure, and stroke. Furthermore, very low values of blood glucose (hypoglycemia) for even a short duration can result in loss of consciousness and coma.
The figure 1 shows the complications of type 2 diabetes which is a syndrome characterized by insulin deficiency, insulin resistance, and increased hepatic glucose production. These metabolic abnormalities are treated by use of various medications which are designed to correct one or more of these metabolic abnormalities (Saltiel & Olefsky, 2001).
Type 2 diabetes is most common in adults, although younger people are also developing this type of disease. It starts with a slow onset with thirst, frequent urination, weight loss developing over weeks to months. It is also considered to run in families but it may happen with a person without a family history of diabetes as well.
In its early stages, many people with type 2 diabetes can control their blood glucose levels by losing weight, eating properly and exercising. Many may subsequently need oral medication, and some people with type 2 diabetes may eventually need insulin shots to control their diabetes and avoid the disease's serious complications (Saltiel & Olefsky, 2001). Even though there is no cure for diabetes, proper treatment and glucose control enable people with type 2 diabetes to live normal, productive lives. A major advance for people at risk of developing type 2 diabetes - such as family members of those with the condition - occurred recently when it was shown that diet and exercise can prevent or delay type 2 diabetes. 2004), however, population-based data on the prevalence of diabetic retinopathy in Pakistan and on the visual impairment due to diabetic retinopathy is lacking and only the hospital-based data is available (Kayani et al. Diabetic nephropathy is present in 18% of people diagnosed with diabetes (DSG, 1993) and is a leading cause of end-stage renal disease (Molitch et al.
2003)Stroke: diabetes is associated with a 2- to 4-fold increase in cardiovascular mortality and stroke (Kannel et al. Therefore, early detection and treatment of diabetes is essential in order to reduce the impact of its serious complications.
Development of type 2 diabetesDevelopment of type 2 diabetes is the result of multifactorial influences that include lifestyle, environment and genetics. The disease arises when insulin resistance-induced compensatory insulin secretion is exhausted.
A high-caloric diet coupled with a sedentary lifestyle is one of the major contributing factors in the development of the insulin resistance and pancreatic ?-cell dysfunction as shown in Figure 2.
However, a predisposing genetic background has long been suspected in playing a contributing role in the development of type 2 diabetes.
The metabolic syndrome is defined as a clustering of atherosclerotic cardiovascular disease risk factors that include visceral adiposity (obesity), insulin resistance, low levels of HDLs and a systemic proinflammatory state. There are key components to the metabolic syndrome which include in addition to insulin resistance (the hallmark feature of the syndrome), hypertension, dyslipidemia, chronic inflammation, impaired fibrinolysis, procoagulation and most telling central obesity.3. Randomized controlled trials with fenugreekThe multiple trials in the past have shown conflicting results of the effect of fenugreek on the patients of type 2 diabetes. These studies showed some positive results on fasting serum glucose but did not examine hemoglobin (HbA1c) levels.
Gupta et al (2001) reported the results of a small randomized, controlled, double-blind trial to evaluate the effects of fenugreek seeds on glycemic control.
The authors reported that there were no significant differences between groups in mean glucose tolerance test values at the study's end. However, the trial may have been too small or brief to detect significant mean differences between groups. Raghuram et al (1994) reported the results of a randomized, controlled, crossover trial of fenugreek seeds in 10 patients with type 2 diabetes.
In the fenugreek-treated patients, statistically significant mean improvements were reported for glucose-tolerance test scores and serum-clearance rates of glucose. Sharma and Raghuram (1990) conducted two randomized, controlled, crossover studies in patients with type 2 diabetes. Significant mean improvements in fasting blood-glucose levels and glucose-tolerance test results were described in the fenugreek-treated patients.
Moosa et al (2006) conducted study to evaluate the effect of fenugreek on serum lipid profile in hypercholesteremic type 2 diabetic patients and concluded that fenugreek seeds powder significantly reduced serum total cholesterol, triglyceride and LDL-cholesterol but serum HDL-cholesterol level elevation was not significant.
Neeraja and Rajyalakshmi (1996) presented a case series including six men with type 2 diabetes and six without diabetes. The cases suggested fenugreek reduced postprandial hyperglycemia primarily in subjects with diabetes, but less so in subjects without diabetes. The studies conducted to date have been methodologically weak, lacking adequate descriptions of blinding, randomization, baseline patient characteristics, statistical analysis, and standardization data for the therapy used.
Demonstrating the efficacy of fenugreek has also been confounded by inconsistencies in the preparations, dosing regimens, and outcome measures used in the trials. Moreover, none of the investigations have been conducted over the longer period (Basch, 2003). Method of patient selectionThe patients were recruited from the diabetic medical centre in rural area of Peshawar conducting the study of management of type 2 diabetes among the population aged 30-65 years.
Patients having coexisting liver, kidney or thyroid disorder were not included in the study.
Diabetes Criteria for patientsThe well known standard screening test for diabetes, the fasting plasma glucose (FPG), is also a component of diagnostic testing.


The FPG test and the 75-g oral glucose tolerance test (OGTT) are both suitable tests for diabetes; however, the FPG test is preferred in clinical settings because it is easier and faster to perform, more convenient and acceptable to patients, and less expensive. When it was found necessary, plasma glucose testing was also performed on individuals who have taken food or drink shortly before testing.
Such tests are referred to as casual plasma glucose measurements and are given without regard to time of last meal.
A confirmatory FPG test or OGTT was also completed on such patients on a different day if the clinical condition of the patient permits.
Laboratory measurement of plasma glucose concentration is performed on venous samples with enzymatic assay techniques, and the above-mentioned values are based on the use of such methods. The A1C test values remain a valuable tool for monitoring glycemia, but it is not currently recommended for the screening or diagnosis of diabetes.
Pencil and paper tests, such as the American Diabetes Association’s risk test, may be useful for educational purposes but do not perform well as stand-alone tests. Capillary blood glucose testing using a reflectance blood glucose meter has also been used but because of the imprecision of this method, it is better used for self-monitoring rather than as a screening tool. Determination of study sample size The study sample size was determined based on the assumption of the estimation of Standard Deviation (SD). Therefore, the study design was selected to detect an effect size of 0.5 SD lowering of HbA1c.
It was assumed that 15% patients might be lost to follow-up in control group over the period of three months and only 5 % patients will be lost to follow-up in intervention group. This assumption was based on the popularity of fenugreek seeds used by diabetic patients in sub-continent to manage their glycemic control. Study population and randomizationInitially 325 patients with type 2 diabetes were invited to pre-randomized interview, out of which only 210 patients were included in the actual trial. Out of the 325 patients, 93 patients did not meet the inclusion criteria and 22 patients refused to participate in the trial.
Finally, two hundred and ten (210) patients agreed to participate and signed informed consent documents at the clinic where they used to visit for their usual medical care for diabetes.
Therefore, 102 patients were randomized to intervention group (fenugreek supplements) and 108 to the control group (usual medical care).
The randomization code was developed using a computer random number generator in a block size of eight patients. That helped to allocate patients to the intervention and control groups equally in each block – that is each patient would have an equal chance of allocation to either group. Once the randomization phase was completed, all patients were instructed to follow-up the usual medical care for their diabetes for the duration of the 90 days trial. The patients were allowed to adjust their usual medications as recommended by their doctors.
In addition, each patient was asked to go for blood test for HbA1c on day 1 and then return to give blood sample after 90 days. In addition, participants were advised not to take any other new treatments for the management of type 2 diabetes during the trial periods.
The control group in randomized controlled trial received medical care from a physician-coordinated team. This team included physicians, nurses, dietitians, and mental health professionals with expertise and a special interest in diabetes.
It is essential in this collaborative and integrated team approach that individuals with diabetes assume an active role in their care. The management plan in that group was based on individualized therapeutic alliance among the patient and family, the physician, and other members of the health care team. This plan has recognized diabetes self-management education as an integral component of care and in developing the plan, consideration was given to the patient’s age, work schedule and conditions, physical activity, eating patterns, social situation and personality, cultural factors, and presence of complications of diabetes or other medical conditions. Patient self-management was emphasized, and the plan emphasized the involvement of the patient in problem-solving as much as possible. A variety of strategies and techniques were employed to provide adequate education and development of problem-solving skills in the various aspects of diabetes management. During the implementation of the management plan it was assured that each aspect of diabetes management was understood and agreed on by the patient and the care providers and that the goals and treatment plan were reasonable.
Those patients randomized to take fenugreek (intervention group) received 100 gms fenugreek seeds powder from the pharmacy in the clinic. They were instructed to take 50 gms doses twice a day at lunch and dinner time in addition to their normal medications for diabetes. Those patients randomized to usual medical care (control group) were instructed to take their normal medicines and follow-up with their doctor as per their normal schedule.
All participants were contacted again after 90 days (3-months) to give their blood sample for HbA1c testing. At that time, a questionnaire was sent via e-mail to participants in both intervention and control groups to assess the progress of the fenugreek treatment and clinical care without fenugreek.
The clinical and demographic characteristics of the patients in the two groups were well balanced at randomization. A demographic measure included age, gender, weight, ethnicity, religion, marital status, previous episodes of glycemic control, previous and current treatments of type 2 diabetes. The table 3 gives baseline characteristics of intervention and control groups in RCT trial. Diabetes treatment with medicationsThe treatment options of type 2 diabetes is shown in figure 4 suggesting the specific areas of actions using medications which influence the various organs of the body to correct the metabolic abnormalities such as reducing the liver glucose production, slowing down absorption of sugars from the gut and reducing the insulin resistance.
There are currently six distinct classes of hypoglycemic agents available to treat type 2 diabetes. The patients in both the groups in RCT trials received medications recommended by their physicians. The most common combinations among both the groups were Meglitinide (repaglinide) with Thiazolidendiones and Sulfonylurea with Biguanides.
Details of hypoglycaemic medications used in RCT trialThe diabetes medications mentioned in table 4 work in different ways but the main function of all these medications include lowering blood sugar levels; help improve the body’s use of glucose, decrease the symptoms of high blood sugar, help keeping patients with diabetes functioning normally and may prevent the complications, organ-damaging effects and premature deaths diabetes can cause. Since the drugs work in different ways, these are sometimes used in combination to enhance the effectiveness of treatment.
In this RCT trial Sulfonylurea was used in combination with Biguanide (metformin) and Meglitinide was used in combination with Thiazolidinedione. The main function of Sulfonylurea is to bind and inhibit the pancreatic ATP-dependent potassium channel that is normally involved in glucose-mediated insulin secretion. Like the sulfonylurea, meglitinide therapy results in significant reduction in fasting glucose as well as HbA1c.
The mechanism of action of the meglitinide is initiated by binding to a receptor on the pancreatic ?-cell that is distinct from the receptors for the sulfonylurea.
Metformin is a member of this class and is currently the most widely prescribed insulin-sensitizing drug in current clinical use. Metformin administration does not lead to increased insulin release from the pancreas and as such the risk of hypoglycemia is minimal. Because the major site of action for metformin is the liver its use can be contraindicated in patients with liver dysfunction.
Thiazolidinedione: The thiazolidinedione (pioglitazone) has proven useful in treating the hyperglycemia associated with insulin-resistance in both type 2 diabetes and non-diabetic conditions. The net effect of the thiazolidinedione is a potentiation of the actions of insulin in liver, adipose tissue and skeletal muscle, increased peripheral glucose disposal and a decrease in glucose output by the liver. Diabetes treatment with diet and exerciseThe normal diabetes treatment addresses the issues related to unhealthy lifestyles, such as lack of physical activity and excessive eating, which are the main causes to initiate and propagate the majority of type 2 diabetes (Michael, 2007). Studies have demonstrated strong relationship between excess weight and the risk of developing type 2 diabetes, hypertension, and hyperlipidemia.
Therefore, the objective of physicians is to motivate patients to lose weight and exercise to improve the control of diabetes and slow down or even reverse the natural course of the disease (Michael, 2007).However, it is difficult to overstate the importance of the relationship between lifestyle and the risk of developing type 2 diabetes. There are prospective studies which have demonstrated that lifestyle modification in the form of diet and regular moderate exercise sharply decrease the likelihood of developing type 2 diabetes in high-risk individuals who have impaired glucose tolerance or impaired fasting glucose.
The effectiveness of this intervention superseded that of metformin therapy (Knowler et al.
In this RCT trial, physicians compiled the flow scheme shown in Figure 5 which represents the method of treatment of type 2 diabetes by the combination of diet, exercise and medication for diabetes monitoring and control. It has been divided into two segments: for obese and normal weight patients and the combination of medication for both the groups of patients.
Dietary consideration for patients (intervention and control group)It has been recommended that carbohydrate and monosaturated fat consumption for the patients with type 2 diabetes should comprise 60-70% of total calories. However, there is some concern that increased unsaturated fat consumption may promote weight gain in obese patients with type 2 diabetes and therefore may cause in reduction of insulin sensitivity (Bantle et al. The “glycemic index” is an attempt to compare the glycemic effects of various foods to a standard, such as white bread. Although several authors have proposed its clinical usefulness in controlling postprandial hyperglycemia, prospective studies have not demonstrated a clear improvement in hemoglobin (HbA1c) in patients using low-glycemic index diets (Michael, 2007). The physicians in this trial have recommended the best mix of carbohydrate, protein, and fat that was adjusted to meet the metabolic goals and individual preference of the patients with diabetes in both the intervention and control groups. It has been recommended for individuals with diabetes, that the use of the glycemic index and glycemic load may provide a modest additional benefit for glycemic control over that observed when total carbohydrate is considered alone (ADA, 2011). Monitoring carbohydrate, whether by carbohydrate counting, choices, or experience-based estimation, remain a key strategy in achieving glycemic control. Physical activity consideration for patients (intervention and control group)Physical activity is a key component of lifestyle modification that can help individuals prevent or control type 2 diabetes. It is considered that diet is probably more important in the initial phases of weight loss, incorporating exercise as part of a weight loss regimen helps maintain weight and prevent weight regain (Klein et al. In this trial, the message was given to both the groups that as little as 30 minutes of moderate physical activity daily may offer greater benefits to these patients in managing their diabetes. It has also been reported that in patients with type 2 diabetes, structured regimens of physical activity for 8 weeks or longer improved HbA1c independent of changes in body mass (Sigal et al. The evidence supports the contention that controlling blood glucose through modification of diet and lifestyle should be mainstay of diabetes therapy.
It was found in this RCT that despite being one of the most time-consuming discussions with the patients in both the groups, this is probably the most important patient-physician discussion in regard to diabetes control and prevention of disease progression and complications.
Statistical analysisWe analysed the primary outcome by an un-paired sample t-test (mean difference between baseline and final HbA1c).
The statistical analysis was carried out on an intention to treat basis and that was subject to the availability of data at follow up as well as at entry level for individual patients.



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Comments

  1. 454

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    29.11.2014

  2. ELMAYE2

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    29.11.2014