A Trial of Two Diets for Weight and Diabetes Management

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Obesity
• Interventions: Behavioral: Lifestyle Modification

• Registration Number: NCT00729196
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary

The purpose of this study is to determine whether a low-fat or low-glycemic load diet is more effective for controlling weight and blood glucose in persons with type 2 diabetes.

Detailed Description

This research is a randomized controlled trial to compare long-term outcomes behavioral weight loss interventions that include either low-fat or low-glycemic load dietary instruction. Targets for energy intake and expenditure, and behavioral skills taught, are identical across the two diets. Additionally, both treatments include 20 weekly group sessions, followed by 10 every-other-week sessions. Participants are overweight and obese adults with type 2 diabetes. The primary outcomes are changes in weight and glycated hemoglobin. Those randomized to the low-glycemic load diet are expected to achieve greater weight losses and maintain better glycemic control at the end of treatment (i.e., week 40) and after 1 year of no-treatment follow-up (i.e., week 92).

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2008-08-05
• Study First Submitted QC: 2008-08-05
• Study First Posted: 2008-08-07
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-31
• Last Update Posted: 2011-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Type 2 Diabetes Mellitus
• Body mass index (BMI) of 27 to 45 kg/m2 with weight </= 136 kg (300 lbs.
• Capacity to provide written informed consent
• Systolic blood pressure between 90 and 160 mm Hg, inclusive.
• Diastolic blood pressure between 65 and 100 mm Hg, inclusive.
• Resting heart rate between 65 and 90 beats per minute, inclusive.

Exclusion Criteria

• a recent (i.e., within 1 year) myocardial infarction
• unstable angina
• malignant arrhythmias
• history of cerebrovascular, renal, or hepatic disease
• history of seizures
• protein wasting diseases (e.g., Cushing's syndrome)
• uncontrolled hypertension (> 160/100 mm Hg)
• type 1 diabetes
• uncontrolled thyroid disease
• pregnancy or lactation
• electrolyte abnormalities
• clinically significant psychosocial impairment (principally, major depression)
• treatment with steroids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lifestyle Modification	Low-Glycemic Load Diet
2	Lifestyle Modification	Low-Fat Diet

Primary Outcome Measures

Name	Time	Method
Percent change in weight	92 weeks

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c	92 weeks

Trial Locations

Locations (1)

University of Pennsylvania, Center for Weight and Eating Disorders; 🇺🇸 Philadelphia, Pennsylvania, United States