Dietary Interventions in Type 2 Obese Diabetic Patients in the Community

Study Overview
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Brief Summary
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Obese patients with type 2 diabetes often fail to loose weight and thus do not succeed in improving their sugar and lipid profiles and remain at high risk for diabetes complications The study enrolled 259 obese diabetic patients attending HMO clinics in central Israel. Over a 6 month period the participants met with a dietitian every fortnight and attended group lectures every 2 months. The objective of this intervention was to compare three dietary intervention along with close monitoring of the patients by dietitians, regarding blood lipid and sugar balance as well as weight loss. The three diets are the American Diabetes Association (ADA) diet from 2003; a diet containing low glycemic index carbohydrate otherwise similar to the ADA diet; and a low glycemic index diet with more fat than the other 2 diets with high proportion of mono-unsaturated fatty acids. Patients were individually randomized to receive one of the three diets. Among the measures obtained every 3 months for the first year and every 6 months thereafter are weight, fasting insulin and glucose, glycosylated hemoglobin, blood and urine chemistry profiles and lipid profile.

Official Title
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Community Trial to Assess the Effect of Nutritional Intervention Models on Medical Outcomes Among Obese Type 2 Diabetic Patients

Conditions
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Diabetes Type 2

Intervention / Treatment
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* Behavioral: MUFA diet
* Behavioral: ADA 2003
* Behavioral: Low Glycemic index (LGI) diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 30-65years DM2 diagnosed within 1-10 years Body mass index (BMI) 27-34 kg/m² Last HbA1c measurement 7%-10% Last plasma triglyceride (TG) levels 160-400 mg/dl Last serum creatinine less than 1.4 mg/dl No change in diabetes medication for at least three months before entering the study Exclusion Criteria: Proliferative diabetic retinopathy Current insulin treatment Active oncologic or psychiatric disease Uncontrolled hypothyroidism or hyperthyroidism

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>ADA 2003 diet | Behavioral: ADA 2003<br>* Patients were advised to consume 23 cal/kg/day. The diet contained sodium (up to 3000mg/day), potassium (more than 3000 mg/day), calcium (around 1300 mg/day) and magnesium (more than 800 mg/day). The carbohydrates are with mixed glycemic index. The diet contains 50-55% carbohydrates, 30% fat and 15-20% protein. Participants were advised to eat 4-6 meals per day according to their lifestyle and to participate in 30-45 min of aerobic activity at least 3 days a week.<br>|
| Active Comparator: 2<br>Low Glycemic index (LGI) diet | Behavioral: Low Glycemic index (LGI) diet<br>* Patients were advised to consume 23 cal/kg/day. The diet contained sodium (up to 3000mg/day), potassium (more than 3000 mg/day), calcium (around 1300 mg/day) and magnesium (more than 800 mg/day). LGI diet included only low glycemic index carbohydrates. The diet consisted of 50-55% carbohydrates, 30% fat and 20%. protein. Participants were advised to eat 4-6 meals per day according to their lifestyle and to participate in 30-45 min of aerobic activity at least 3 days a week.<br>|
| Active Comparator: 3<br>MUFA diet | Behavioral: MUFA diet<br>* Patients were advised to consume 23 cal/kg/day. The diet contained sodium (up to 3000mg/day), potassium (more than 3000 mg/day), calcium (around 1300 mg/day) and magnesium (more than 800 mg/day). MUFA diet included only low glycemic index carbohydrates. The diet consisted of 35% carbohydrates and 45% fat (50% of them were mono-unsaturated fatty acids [MUFA]). Participants were advised to eat 4-6 meals per day according to their lifestyle and to participate in 30-45 min of aerobic activity at least 3 days a week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride level, glycated hemoglobin level, fasting plasma glucose |  | baseline and every 3 months during year 1, every 6 months therafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight, BMI, waist hip circumference, insulin resistance using HOMA (fasting glucose to fasting insulin ration), HDL-Cholesterol level. |  | baseline, every 3 months in year 1, every 6 months therafter |