A Trial of Two Diets for Weight and Diabetes Management

NCT00729196 | Completed DMC

• 2 other identifiers: K23 DK70777 (completed)K23DK070777
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Obesity

Keywords

Obesity; Type 2 Diabetes; Glycemic Load; Weight Loss; Glycated Hemoglobin

Outcome Measures

Primary Outcomes (1)

• Percent change in weight

  92 weeks

Secondary Outcomes (1)

• Change in HbA1c

  92 weeks

Study Arms (2)

1

EXPERIMENTAL

Low-Glycemic Load Diet

Behavioral: Lifestyle Modification

2

ACTIVE COMPARATOR

Low-Fat Diet

Behavioral: Lifestyle Modification

Interventions

Lifestyle Modification BEHAVIORAL

Weekly group therapy for 20 weeks, followed by bi-weekly group therapy for 20 weeks

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• University of Pennsylvania: collaborator

Study Sites (1)

University of Pennsylvania, Center for Weight and Eating Disorders

Philadelphia, Pennsylvania, 19104-3309, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Anthony N Fabricatore, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 5, 2008
• First Posted: August 7, 2008
• Study Start: July 1, 2005
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 1, 2011

Record last verified: 2011-01

Locations

US (1)