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 intervention
    Opt-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

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48106
Amy E Rothberg, MD, PhD
734-647-5871
Nicole Miller, MPH, RD
734-232-3587
Amy E Rothberg, MD, PhD (PRINCIPAL_INVESTIGATOR)

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