Diabetes Type 2 Clinical Trial
Official title:
Community Trial to Assess the Effect of Nutritional Intervention Models on Medical Outcomes Among Obese Type 2 Diabetic Patients
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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