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Hypertension is common in CKD, and is a risk factor for faster progression of kidney disease and development and worsening of CVD.
1.2 Modifications to antihypertensive therapy should be considered based on the level of proteinuria during treatment (C) (see Guidelines 8, 9, 10,11). 1.3 Antihypertensive therapy should be coordinated with other therapies for CKD as part of a multi-intervention strategy (A). 1.4 If there is a discrepancy between the treatment recommended to slow progression of CKD and to reduce the risk of CVD, individual decision-making should be based on risk stratification (C). CKD is a world-wide public health problem, with increasing incidence and prevalence, high cost, and poor outcomes.
The Joint National Committee (JNC) for Prevention, Detection, Evaluation and Treatment of High Blood Pressure issues regular reports that are meant to provide guidance for primary-care clinicians. Antihypertensive therapy includes lifestyle modifications and pharmacological therapy that reduce blood pressure, in patients with or without hypertension.
Lifestyle modifications include changes in diet, exercise, and habits that may slow the progression of CKD or lower the risk of CVD. Pharmacological therapy includes selection of antihypertensive agents and blood pressure goals.
Level of proteinuria and changes in the level of proteinuria may be a guide to modifications of antihypertensive therapy (Weak).
Most patients with CKD will require multiple interventions to slow progression of CKD and prevent development or worsening of CVD (Strong).
Individual decision-making is necessary to resolve discrepancies between recommendations for slowing CKD progression and reducing CVD risk (Strong). In addition to the JNC, several organizations have issued recommendations for blood pressure management in CKD.
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. Some antihypertensive agents also slow the progression of kidney disease by mechanisms in addition to their antihypertensive effect. The seventh report (JNC 7), issued in 2003, suggests stratification of risk for CVD in individuals with high blood pressure to determine the intensity of treatment. Antihypertensive agents are defined as agents that lower blood pressure and are usually prescribed to hypertensive individuals for this purpose. Figure 28 and Table 45 describe a the general approach recommended by the Work Group to integrate goals of lowering blood pressure, reducing CVD risk, slowing progression of kidney disease, and considerations regarding proteinuria. The Work Group accepted the principle that recommendations should maximize net health benefits for the target population (see Appendix 1).
However, it should be noted that most clinical studies (observational studies and controlled trials) do not provide an adequate framework for examining the possibility of conflicts. For example, should a patient with Stage 3 CKD due to Type 1 diabetes, a recent myocardial infarction, and Stage 1 hypertension be treated with an ACE inhibitor, beta-blocker, or diuretic?
Previous recommendations by the NKF and other groups are listed in Table 46.1,15,108-121 Guidelines for CVD risk reduction in individuals without CKD are reviewed in Guideline 7. JNC 6 suggested risk stratification of individuals with hypertension for therapeutic decisions.15 Although JNC 7 simplified this classification, the Work Group found the concepts useful in its deliberations.
IntroductionThe incidence of type 2 diabetes is increasing worldwide, resulting in large measure from the increasing prevalence of obesity (Yale, 2000).
Increasing evidence indicates that the adverse outcomes of CKD can often be prevented or delayed through early detection and treatment.
The goals of antihypertensive therapy in CKD are to lower blood pressure, reduce the risk of CVD, and slow progression of CKD. In certain types of CKD, specific classes of antihypertensive agents, notably those that inhibit the renin-angiotensin system (RAS), are preferred agents for slowing progression of kidney disease. It is a marker for kidney damage, a clue to the type (diagnosis of CKD), and a risk factor for faster progression of kidney disease and development of CVD, and it identifies patients who benefit more from preferred agents and a lower target blood pressure (Table 29).
A multidisciplinary team could include one or more of the following in addition to the physician: nurse practitioner, registered nurse, registered dietitian, masters prepared social worker, pharmacist, and physician assistant.
Having defined the goals for antihypertensive therapy to include slowing progression of CKD and reducing CVD risk in addition to lowering blood pressure, the Work Group searched for evidence in the target population for each clinical outcome. All classes of agents may be indicated, but if the blood pressure is too low, which agents should be used preferentially?
There is a spectrum of risk from very high to low, and patients were classified into three general risk categories. Diabetes mellitus is a pandemic disease and is one of the main threats to human health (Narayan, 2005). It concludes with a review of key recommendations of the guidelines and compares the recommendations to those made by the JNC 7, as well as with previous reports by the NKF and ADA. It is important to note that antihypertensive agents may have salutary effects on CKD and CVD in addition to lowering systemic blood pressure, such as reducing proteinuria, slowing GFR decline, and inhibiting other pathogenetic mechanisms of kidney disease progression and CVD.
Thus, the guidelines recommend the use of specific classes of antihypertensive agents in certain types of CKD, even if hypertension is not present. However, there have been few controlled trials to demonstrate the efficacy of blood pressure lowering to reduce the risk of CVD in CKD; therefore, the Work Group made recommendations for CKD based on extrapolation from evidence on the efficacy of antihypertensive therapy in the general population. In addition, some other modifiable risk factors (proteinuria and activity of the RAS) are also affected by antihypertensive therapy. In addition, it has been hypothesized that changes in the level of proteinuria during treatment may be a surrogate outcome for kidney disease progression. In general, there were few studies that adequately assessed both outcomes; thus, the Work Group made recommendations on the basis of separate studies on each outcome. In part, differences among studies may be related to differences in study populations and definition and ascertainment of endpoints. Where recommendations are discrepant, health-care providers must make decisions to maximize the net health benefits for the individual patient. In this discussion, the focus is on recommendations by JNC and ADA because these are the most widely used guidelines for treatment of individuals with hypertension and diabetes—the two most common causes of CKD. These definitions and goals do not differ according to age (among adults), gender, or race.
Limitations, implementation issues, and research recommendations are covered in subsequent guidelines. General principles of pharmacological therapy and target blood pressure for reducing CVD risk are discussed in Guideline 7. The Work Group concluded that there is not yet sufficient evidence to confirm this hypothesis. This is a reasonable approach, if the recommendations to slow progression of CKD and reduce risk of CVD agree; however, if there is a discrepancy between recommendations, this approach may not be adequate.
For example, studies on the progression of CKD have included patients with either markers of kidney damage (eg, diabetic patients with proteinuria) or decreased GFR (eg, most studies of nondiabetic kidney disease) and have carefully measured kidney function. The Work Group recommends that such individual decision-making be based on risk stratification. Lifestyle modification is recommended for 6 to 12 months, followed by antihypertensive therapy if blood pressure remains above goal. 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). In addition, for some types of CKD, the blood pressure goal recommended for CVD risk reduction in high-risk groups has been shown to slow the progression of CKD. However, it was the opinion of the Work Group that proteinuria should be monitored during the course of CKD, and that under some circumstances it would be appropriate to consider modifications to antihypertensive therapy, such as a lower blood pressure goal or measures to reduce proteinuria, such as increasing the dosage of preferred agents and selection of additional antihypertensive agents (Table 44). A more detailed approach to decision-making and protocols for action are given in later sections.
Other approaches, such as decision analysis, with or without regard to cost, could be useful to determine net health benefits in this situation.
On the other hand, studies of CVD risk reduction have generally excluded patients with elevated serum creatinine, did not routinely measure urine protein, and concentrated on ascertainment of CVD events. In general, the selection of antihypertensive therapy should be directed to the clinical condition that is most likely to occur and that has the most serious consequences on overall survival and quality of life of the individual patient. The recommended initial antihypertensive agent is generally a diuretic, in combination with an ACE inhibitor, ARB, ß-adrenergic blocker, or a calcium-channel blocker if more than one agent is necessary to reach the target blood pressure. According to a 2005 US Government estimate, approximately 21 million people in the United States have diabetes (Gerich, 2005). ACE inhibitors and angiotensin receptor blockers are discussed in Guideline 11, and diuretics are discussed in Guideline 12.
Thus, the Work Group recommended that antihypertensive therapy in CKD also be guided by the type of kidney disease. Thus, it is likely that studies on CKD enrolled patients at greater risk for progression of CKD than for CVD events and had greater statistical power to detect effects on CKD progression than on CVD events.
Clinical practice guidelines cannot substitute for individual decision-making in patients with complex medical problems. Because there are few studies of antihypertensive therapy on CVD in CKD and because patients with CKD are in the highest-risk category for CVD, the Work Group recommends extrapolating the results from studies in the general population and other highest-risk populations to CKD (see Guideline 7). In 2002, diabetes was the sixth leading cause of death and had an estimated total cost of $132 billion (Hogan et al. In general, these measures should be undertaken in consultation with a kidney disease specialist. Similarly, studies on CVD enrolled patients at greater risk for CVD events than for progression of CKD and had greater statistical power to detect effects on CVD events than progression of CKD. Hence, the Work Group generally restricted the interpretation of these studies to the primary outcome, as specified in advance by the authors.


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. Differences in study design are discussed in an attempt to resolve discrepancies in findings and, in some studies, secondary outcomes are discussed.
Overall recommendations are based on the sum of evidence, after taking into consideration all these factors.
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.
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. 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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