Clinical trial NCT00520182: Dietary Interventions in Type 2 Obese Diabetic Patients in the Community
Official title: Community Trial to Assess the Effect of Nutritional Intervention Models on Medical Outcomes Among Obese Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes Type 2
Lead sponsor: Ben-Gurion University of the Negev
Sponsor class: OTHER
Collaborators: name: The S. Daniel Abraham International Center for Health and Nutrition
name: Clalit Health Services
First posted: 2007-08-23
Enrollment: 259
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Triglyceride level, glycated hemoglobin level, fasting plasma glucose
timeFrame: 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.
timeFrame: baseline, every 3 months in year 1, every 6 months therafter
Other outcomes:
Locations:
city: Rehovot, Petach Tikva, Ramle
country: Israel
facility: Clalit HMO
state: Central region
Study officials:
affiliation: Ben-Gurion University of the Negev
name: Drora Fraser, PhD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.2337/dc06-1564.
citation: Elhayany A, Lustman A, Abel R, Attal-Singer J, Vinker S. A low carbohydrate Mediterranean diet improves cardiovascular risk factors and diabetes control among overweight patients with type 2 diabetes mellitus: a 1-year prospective randomized intervention study. Diabetes Obes Metab. 2010 Mar;12(3):204-9. doi: 10.1111/j.1463-1326.2009.01151.x.