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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00729196
First Posted: August 7, 2008
Last Update Posted: February 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Pennsylvania
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial of Two Diets for Weight and Diabetes Management

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Change in HbA1c [ Time Frame: 92 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Anthony N. Fabricatore, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00729196     History of Changes
Other Study ID Numbers: K23 DK70777 (completed)
K23DK070777 ( U.S. NIH Grant/Contract )
First Submitted: August 5, 2008
First Posted: August 7, 2008
Last Update Posted: February 1, 2011
Last Verified: January 2011

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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases