Dietary Interventions in Type 2 Obese Diabetic Patients in the Community

Phase 3UnknownNCT00520182

Ben-Gurion University of the Negev259 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

259

Conditions

Diabetes Type 2

Interventions

MUFA dietBEHAVIORAL

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.

ADA 2003BEHAVIORAL

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.

Low Glycemic index (LGI) dietBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 30-65years 2. DM2 diagnosed within 1-10 years 3. Body mass index (BMI) 27-34 kg/m² 4. Last HbA1c measurement 7%-10% 5. Last plasma triglyceride (TG) levels 160-400 mg/dl 6. Last serum creatinine less than 1.4 mg/dl 7. No change in diabetes medication for at least three months before entering the study Exclusion Criteria: 1. Proliferative diabetic retinopathy 2. Current insulin treatment 3. Active oncologic or psychiatric disease 4. Uncontrolled hypothyroidism or hyperthyroidism

Outcomes

Primary Outcomes

Triglyceride level, glycated hemoglobin level, fasting plasma glucose

Time frame: baseline and every 3 months during year 1, every 6 months therafter

Secondary Outcomes

Weight, BMI, waist hip circumference, insulin resistance using HOMA (fasting glucose to fasting insulin ration), HDL-Cholesterol level.

Time frame: baseline, every 3 months in year 1, every 6 months therafter