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A Trial of Two Diets for Weight and Diabetes Management (Two-for-2)

This study has been completed.
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00729196
First received: August 5, 2008
Last updated: January 31, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Obesity
 Behavioral: Lifestyle Modification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Trial of Two Diets for Weight and Diabetes Management

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Percent change in weight [ Time Frame: 92 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HbA1c [ Time Frame: 92 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2005
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Low-Glycemic Load Diet
 Behavioral: Lifestyle Modification
Weekly group therapy for 20 weeks, followed by bi-weekly group therapy for 20 weeks
Active Comparator: 2
Low-Fat Diet
 Behavioral: Lifestyle Modification
Weekly group therapy for 20 weeks, followed by bi-weekly group therapy for 20 weeks

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729196

Locations
United States, Pennsylvania
University of Pennsylvania, Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, United States, 19104-3309
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Pennsylvania
Investigators
Principal Investigator: Anthony N Fabricatore, Ph.D. University of Pennsylvania
Study Director: Thomas A Wadden, Ph.D. University of Pennsylvania
Study Director: Virginia A Stallings, M.D. Children's Hospital of Philadelphia
Study Director: Stanley Schwartz, M.D. University of Pennsylvania
  More Information

No publications provided

Responsible Party: Anthony N. Fabricatore, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00729196     History of Changes
Other Study ID Numbers: K23 DK70777 (completed), K23 DK070777
Study First Received: August 5, 2008
Last Updated: January 31, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Obesity
Type 2 Diabetes
Glycemic Load
Weight Loss
Glycated Hemoglobin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013