Dietary Interventions in Type 2 Obese Diabetic Patients in the Community
This trial is active, not recruiting.
|Condition||diabetes type 2|
|Treatments||mufa diet, ada 2003, low glycemic index (lgi) diet|
|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|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
|Primary purpose||supportive care|
Triglyceride level, glycated hemoglobin level, fasting plasma glucose
time frame: baseline and every 3 months during year 1, every 6 months therafter
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
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
|Official title||Community Trial to Assess the Effect of Nutritional Intervention Models on Medical Outcomes Among Obese Type 2 Diabetic Patients|
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