Dietary Interventions in Type 2 Obese Diabetic Patients in the Community

Diabetes Type 2 Clinical Trial

— DIPAC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00520182
• Other study ID #: RCT3645
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 22, 2007
• Last updated: September 19, 2007
• Start date: March 2004
• Est. completion date: February 2008

Study information

• Verified date: September 2007
• Source: Ben-Gurion University of the Negev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 259
• Est. completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Behavioral:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Israel	Clalit HMO	Rehovot, Petach Tikva, Ramle	Central region

Sponsors (3)

Lead Sponsor	Collaborator
Ben-Gurion University of the Negev	Clalit Health Services, The S. Daniel Abraham International Center for Health and Nutrition

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Shahar DR, Abel R, Elhayany A, Vardi H, Fraser D. Does dairy calcium intake enhance weight loss among overweight diabetic patients? Diabetes Care. 2007 Mar;30(3):485-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triglyceride level, glycated hemoglobin level, fasting plasma glucose		baseline and every 3 months during year 1, every 6 months therafter
Secondary	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