A Trial of Two Diets for Weight and Diabetes Management
NCT ID: NCT00729196
Last Updated: 2011-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2005-07-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Low-Glycemic Load Diet
Lifestyle Modification
Weekly group therapy for 20 weeks, followed by bi-weekly group therapy for 20 weeks
2
Low-Fat Diet
Lifestyle Modification
Weekly group therapy for 20 weeks, followed by bi-weekly group therapy for 20 weeks
Interventions
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Lifestyle Modification
Weekly group therapy for 20 weeks, followed by bi-weekly group therapy for 20 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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University of Pennsylvania
Principal Investigators
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Anthony N Fabricatore, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Thomas A Wadden, Ph.D.
Role: STUDY_DIRECTOR
University of Pennsylvania
Virginia A Stallings, M.D.
Role: STUDY_DIRECTOR
Children's Hospital of Philadelphia
Stanley Schwartz, M.D.
Role: STUDY_DIRECTOR
University of Pennsylvania
Locations
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University of Pennsylvania, Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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K23 DK70777 (completed)
Identifier Type: -
Identifier Source: org_study_id
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