Dietary Interventions in Type 2 Obese Diabetic Patients in the Community (DIPAC)

Ben-Gurion University of the Negev

Status and phase: Unknown; Phase 3

Conditions: Diabetes Type 2

Treatments: Behavioral: Low Glycemic index (LGI) diet; Behavioral: ADA 2003; Behavioral: MUFA diet

Study type: Interventional

Funder types: Other

Identifiers

NCT00520182

RCT3645

Details and patient eligibility

About

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.

Enrollment: 259 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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259 participants in 3 patient groups

1

Active Comparator group

Description:

ADA 2003 diet

Treatment:

Behavioral: ADA 2003

2

Active Comparator group

Description:

Low Glycemic index (LGI) diet

Treatment:

Behavioral: Low Glycemic index (LGI) diet

3

Active Comparator group

Description:

MUFA diet

Treatment:

Behavioral: MUFA diet