A Trial of Two Diets for Weight and Diabetes Management

Obesity Clinical Trial

— Two-for-2  

Official title:

A Trial of Two Diets for Weight and Diabetes Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729196
• Other study ID #: K23 DK70777 (completed)
• Secondary ID: K23DK070777
• Status: Completed
• Phase: N/A
• First received: August 5, 2008
• Last updated: January 31, 2011
• Start date: July 2005
• Est. completion date: June 2010

Study information

• Verified date: January 2011
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Lifestyle Modification
Weekly group therapy for 20 weeks, followed by bi-weekly group therapy for 20 weeks

Locations

Country	Name	City	State
United States	University of Pennsylvania, Center for Weight and Eating Disorders	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in weight		92 weeks	No
Secondary	Change in HbA1c		92 weeks	No