NCT00729196

A Trial of Two Diets for Weight and Diabetes Management

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Type 2 Diabetes Mellitus
• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle Modification	Weekly group therapy for 20 weeks, followed by bi-weekly group therapy for 20 weeks

Timeline

• Start date: 2005-07-01
• Primary completion: 2010-05-01
• Completion: 2010-06-01
• First posted: 2008-08-07
• Last updated: 2011-02-01

Locations

1 site across 1 country: United States