Overview

This trial is active, not recruiting.

Condition diabetes type 2
Treatments mufa diet, ada 2003, low glycemic index (lgi) diet
Phase phase 3
Sponsor Ben-Gurion University of the Negev
Collaborator The S. Daniel Abraham International Center for Health and Nutrition
Start date March 2004
End date February 2008
Trial size 259 participants
Trial identifier NCT00520182, RCT3645

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(Active Comparator)
ADA 2003 diet
ada 2003
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.
(Active Comparator)
Low Glycemic index (LGI) diet
low glycemic index (lgi) diet
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.
(Active Comparator)
MUFA diet
mufa diet
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.

Primary Outcomes

Measure
Triglyceride level, glycated hemoglobin level, fasting plasma glucose
time frame: baseline and every 3 months during year 1, every 6 months therafter

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 30 years up to 65 years old.

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

Additional Information

Official title Community Trial to Assess the Effect of Nutritional Intervention Models on Medical Outcomes Among Obese Type 2 Diabetic Patients
Trial information was received from ClinicalTrials.gov and was last updated in September 2007.
Information provided to ClinicalTrials.gov by Ben-Gurion University of the Negev.