Identification of Phenotypic Factors That Predict Success for Weight Loss and Long-term Weight Maintenance
Part of paid clinical trials in Ann Arbor, Michigan.
- Sponsor
- University of Michigan
- Study ID
- NCT02043457
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 15 Years - 75 Years
- Healthy Volunteers
- Accepted
Interventions
- phenotyping — OTHER
Study Details
The Investigational Weight Management Clinic now entitled the Weight Management Program at the University of Michigan was created to identify strategies that will result in cost-effective, long term weight management for overweight and obese individuals. The driving hypothesis of the clinic is that the 'one size fits all' philosophy is untenable with a complex disease such as obesity. The clinic will serve as a portal for patients to choose standard clinical care or to explore alternatives from a variety of clinical studies offered through the clinic. These studies will include further investigations into nutrition, the biological basis of weight and weight management and protocols using approved and experimental pharmaceuticals as well as technologies that aid in self-management of weight.
Key Dates
- Start date
- Aug 31, 2009
- Status verified
- Sep 2024
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 3,200 participants (estimated)
Arms
- Arm: Lifestyle interventionOpt-in intervention to include the following procedures, called 'phenotyping' performed at baseline, after 10-15% weight loss from baseline weight or 6 months (whichever comes first) and at end of 2 years while in weight maintenance: oral glucose tolerance test, mixed meal tolerance test, with fasting leptin, biased and unbiased metabolomic profiling, DNA, RNA, muscle and adipose tissue biopsies: measurement of resting energy expenditure by indirect calorimetry; oxidative capacity (V02 peak/max); body composition by Dual Energy X-ray Absorptiometry (DEXA) or air displacement plethysmograph (Bod Pod); inventories of depression and health related quality of life instruments, measures of impulsivity, measures of hunger and appetite, work performance (including presenteeism and absenteeism) and pain survey.
Primary Outcome Measure
Phenotypic factors related to weight loss and long-term weight maintenance [ Time Frame: Change in phenotypic factors from baseline to 3-6 months and at 2 years ]
Central Contacts
- Amy E Rothberg, MD, PhD734-647-5871
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48106 | Amy E Rothberg, MD, PhD (PRINCIPAL_INVESTIGATOR) |
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