Status:
COMPLETED
A Trial of Two Diets for Weight and Diabetes Management
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
University of Pennsylvania
Conditions:
Type 2 Diabetes Mellitus
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ener...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00729196
Start Date
July 1 2005
End Date
June 1 2010
Last Update
February 1 2011
Active Locations (1)
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1
University of Pennsylvania, Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, United States, 19104-3309