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. Send Home Our method Usage examples Index Statistics Advertise with us ContactWe do not evaluate or guarantee the accuracy of any content in this site. The primary treatment for diabetic foot pain is to bring blood glucose levels within the normal range.
Medication can be administered for wounded or infected feet or if the doctor suspects risk of infection.
There are many things which aid diabetes foot pain treatment and delay worsening of the damage. A suited diet can also take care of foot (and nerve) pain by emphasizing on blood sugar control.
Antidepressants have the ability to deal with both pain and depression and can be used as a part of diabetic foot pain treatment.
Changing a therapy can, sometimes, be a helpful technique in combating foot and nerve pain. What is Diabetic Nephropathy?Diabetic nephropathy (''nephropatia diabetica''), also known as Kimmelstiel-Wilson syndrome and intercapillary glomerulonephritis, is a progressive kidney disease caused by angiopathy of capillaries in the kidney glomeruli. IntroductionThe incidence of type 2 diabetes is increasing worldwide, resulting in large measure from the increasing prevalence of obesity (Yale, 2000). These conditions usually result from diabetic microvascular injury involving small blood vessels that supply nerves (vasa nervorum). If antibiotics are prescribed, take the entire course even though positive results can appear within two to three days only.  For treating painful diabetic neuropathy, Cymbalta and Lyrica are the FDA-approved medications. Diabetic foot treatment can also be done at several wound care centers which focus on the lower extremity wounds and ulcers. Debridement of the wound through surgery, improvement of circulation and special dressings can be some of the other treatment procedures.
Routine examination of the feet helps identify any damage even though it is trivial. In case of any injury, attend to it immediately as even a small injury can create havoc for the foot. It is good to lower blood sugar and consequently manage diabetes complications like foot pain.
Apply a water-based moisturizer regularly to prevent cracking but avoid using it between your toes. Lidocaine or capsaicin containing creams may prove useful in controlling pain to certain extent. Even if there is absence of clinical depression in a patient, doctors may prescribe antidepressants to cater to foot pain and other nerve pain. A study pointed out that insulin injections used for glucose control can reduce the likelihood of neuropathy. Another technique which can be helpful in diabetes foot pain treatment is the Dellon procedure.
This non-insulin dependent diabetes mellitus (NIDDM) is primarily characterized by insulin resistance, relative insulin deficiency and hyperglycemia. Insulin resistance and declined ?-cell function are the core consequences of T2DM (Rhodes et al, 2002). Obesity has also been reported as a major factor in the development of insulin resistance and T2DM (Steinberger et al, 2003). In the first phase of insulin secretion, the level of glucose-stimulated insulin release is impaired in Type 2 diabetes condition and decreased in the second phase (Ward et al., 1986). The Endoplasmic reticulum stress pathway which is active in adipose tissue and liver has a molecular link between obesity, decreased insulin sensitivity and type 2 diabetes. Many candidate genes and the susceptible loci responsible for Type 2 diabetes mellitus have already been reported and this list is being increased as the research on genetic variation in this metabolic disorder progresses all over the world. The various factors contributing to the development of T2DM have been depicted in Figure 2. Diabetes mellitus is a pandemic disease and is one of the main threats to human health (Narayan, 2005).
Unattended feet can become problematic and painful, sometimes, leading to amputation as well. Although blood glucose control can worsen symptoms initially, over time, this helps in reducing the symptoms. In case of a severe infection, the doctor can advice hospitalization as giving pills may seem ineffective. High impact exercises may not suit all, particularly when you have lost sensation in the feet. Remembering everything can be cumbersome, so concentrate on the major factors contributing to good glucose control. As far as over the-counter medications are concerned, ibuprofen, naproxen and aspirin may be useful. Diabetes develops due to the genetic predisposition and environmental factors, such as improper food-habit, obesity, sedentary lifestyle, urbanization etc. Abnormalities in ?-cell function that results in T2DM include reduced non-glucose insulin secretagogues stimulation, asynchronous insulin release, a decreased conversion of proinsulin to insulin and a significant decrease in ?-cell mass (Mahler et al., 1999). This endoplasmic reticulum stress in obese individuals leads to suppression of insulin receptor signaling by increased activation of c-Jun N-terminal kinase (JNK) and phosphorylation of insulin receptor substrate–1 (IRS-1) on serine residues (Ozcan et al., 2004).
Besides taking care of your existing problem, the specialist can also provide an excellent resource for how to care for your feet on daily basis.
If you do not have cuts or wounds, bathing and walking may be helpful in reducing foot pain. But remember that over-the-counter pain medicines may not work well can pose (serious) side effects as well. Alterations in glucose metabolism by skeletal muscle and liver, the key insulin-responsive organs that monitors normal glucose homeostasis are seen in Type 2 Diabetes condition (Lowell et al, 2005). Adiponectin, an insulin sensitizing hormone from adipocytes, is a key factor for predicting T2DM (Hara et al., 2005). The disease is progressive and may cause death two or three years after the initial lesions, and is more frequent in men. 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). Diabetic foot pain treatment may also be dealt with shoe inserts, removal of calluses, etc. In the initial stages, insulin resistance is compensated by the hyper-secretion of insulin by the pancreatic ? cells.
The increased levels of non-esterified fatty acid (NEFA), glycerol, Tumor Necrosis Factor-? (TNF-?), and cytokines in the blood plasma lead to the increased level of insulin resistance and reduced insulin sensitivity (Steven et al., 2006). Diabetic nephropathy is the most common cause of chronic kidney failure and end-stage kidney disease in the United States. According to a 2005 US Government estimate, approximately 21 million people in the United States have diabetes (Gerich, 2005).
As insulin resistance increases, the plasma glucose level increases due to the lower insulin sensitivity and the normal functionality of the pancreatic ? cells is lost, leading to hyperglycemia (Weir et al, 2004).
In 2002, diabetes was the sixth leading cause of death and had an estimated total cost of $132 billion (Hogan et al.
Further, once nephropathy develops, the greatest rate of progression is seen in patients with poor control of their blood pressure. 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. Also people with high cholesterol level in their blood have much more risk than others.The earliest detectable change in the course of diabetic nephropathy is a thickening in the glomerulus.
At this stage, the kidney may start allowing more serum albumin (plasma protein) than normal in the urine (albuminuria), and this can be detected by sensitive medical tests for albumin. A quarter of the population of Pakistan would be classified as overweight or obese with the use of Indo-Asian-specific BMI cutoff values. 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. As diabetic nephropathy progresses, increasing numbers of glomeruli are destroyed by nodular glomerulosclerosis. 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.
Now the amounts of albumin being excreted in the urine increases, and may be detected by ordinary urinalysis techniques. 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.
At this stage, a kidney biopsy clearly shows diabetic nephropathy.Diabetic nephropathy continues to get gradually worse. 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). Complications of chronic kidney failure are more likely to occur earlier, and progress more rapidly, when it is caused by diabetes than other causes.
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.


The main treatment, once proteinuria is established, is ACE inhibitor drugs, which usually reduces proteinuria levels and slows the progression of diabetic nephropathy. 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.
Several effects of the ACEIs that may contribute to renal protection have been related to the association of rise in Kinins which is also responsible for some of the side effects associated with ACEIs therapy such as dry cough. The renal protection effect is related to the antihypertensive effects in normal and hypertensive patients, renal vasodilatation resulting in increased renal blood flow and dilatation of the efferent arterioles. Many studies have shown that related drugs, angiotensin receptor blockers (ARBs), have a similar benefit.
Fenugreek seeds also lower serum triglycerides, total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C) (Al-Habori and Raman, 1998). However, combination therapy, according to the ONTARGET study, is known to worsen major renal outcomes, such as increasing serum creatinine and causing a greater decline in estimated glomerular filtration rate (eGFR).Blood-glucose levels should be closely monitored and controlled.
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). As kidney failure progresses, less insulin is excreted, so smaller doses may be needed to control glucose levels.Diet may be modified to help control blood-sugar levels. 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. Modification of protein intake can effect hemodynamic and nonhemodynamic injury.High blood pressure should be aggressively treated with antihypertensive medications, in order to reduce the risks of kidney, eye, and blood vessel damage in the body. 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”? Urinary tract and other infections are common and can be treated with appropriate antibiotics.Dialysis may be necessary once end-stage renal disease develops.
Characteristics of type 2 diabetesType 2 diabetes is associated with certain ethnic groups, obesity, family history of diabetes, and physical inactivity, among other factors. These include, but are not limited to, bardoxolone methyl, olmesartan medoxomil, sulodexide, and avosentan This article is licensed under the Creative Commons Attribution-ShareAlike License. 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). There is an increase in blood pressure (hypertension) and fluid retention in the body plus a reduced plasma oncotic pressure causes oedema. Type 2 diabetes is most common in adults, although younger people are also developing this type of disease. Other complications may be arteriosclerosis of the renal artery and proteinuria.Throughout its early course, diabetic nephropathy has no symptoms. 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. Most often, the diagnosis is suspected when a routine urinalysis of a person with diabetes shows too much protein in the urine (proteinuria). The urinalysis may also show glucose in the urine, especially if blood glucose is poorly controlled. Serum creatinine and BUN may increase as kidney damage progresses.A kidney biopsy confirms the diagnosis, although it is not always necessary if the case is straightforward, with a documented progression of proteinuria over time and presence of diabetic retinopathy on examination of the retina of the eyes. 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. The differences between mean changes were tested by unpaired t tests, and ?2 tests (chi-squared test) were used to test for differences in proportions between the fenugreek treatment and clinical based treatment groups.



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