Viewing Study NCT00520182



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Last Modification Date: 2024-10-26 @ 9:35 AM
Study NCT ID: NCT00520182
Status: UNKNOWN
Last Update Posted: 2007-09-20
First Post: 2007-08-22

Brief Title: Dietary Interventions in Type 2 Obese Diabetic Patients in the Community
Sponsor: Ben-Gurion University of the Negev
Organization: Ben-Gurion University of the Negev

Study Overview

Official Title: Community Trial to Assess the Effect of Nutritional Intervention Models on Medical Outcomes Among Obese Type 2 Diabetic Patients
Status: UNKNOWN
Status Verified Date: 2007-09
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: DIPAC
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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None