Dietary Interventions in Type 2 Obese Diabetic Patients in the Community

Phase 3

• Conditions: Diabetes Type 2
• Interventions: Behavioral: ADA 2003; Behavioral: Low Glycemic index (LGI) diet; Behavioral: MUFA diet

• Registration Number: NCT00520182
• Lead Sponsor: Ben-Gurion University of the Negev

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2007-08-22
• Study First Submitted QC: 2007-08-22
• Study First Posted: 2007-08-23
• Status Verified: 2007-09
• Last Update Submitted: 2007-09-19
• Last Update Posted: 2007-09-20
• Study Completion: 2008-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 259

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ADA 2003	ADA 2003 diet
2	Low Glycemic index (LGI) diet	Low Glycemic index (LGI) diet
3	MUFA diet	MUFA diet

Primary Outcome Measures

Name	Time	Method
Triglyceride level, glycated hemoglobin level, fasting plasma glucose	baseline and every 3 months during year 1, every 6 months therafter

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Clalit HMO; 🇮🇱 Rehovot, Petach Tikva, Ramle, Central region, Israel