Identification of Phenotypic Factors That Predict Success for Weight Loss and Long-term Weight Maintenance
ConditionObesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15-75
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Obese males and females: age >20 years; Obese population defined as BMI > or = 27 kg/m2
Lean population BMI < 27 but > 17 kg/m2
Able and willing to provide written informed consent for the trial
Disqualifiers
Evidence of inherited disorders of lipid metabolism.
History of Cancer within the last 5 years
Human immunodeficiency virus (HIV) antibody positive.
Patients with solid organ transplants.
Trial population
3000 obese participating in a 2 year clinical weight loss and weight maintenance program and 200 lean controls may opt-in to participate in a number of evaluations including depression inventory and HRQOL questionnaires, assessing hunger and appetite, work performance (including presenteeism and absenteeism), pain survey, oral glucose tolerance testing, mixed meal tolerance testing with metabolomics, DNA, RNA, with or without muscle and adipose tissue biopsies, body composition by DEXA or BodPod, measurements of REE and V02 max before at baseline, at 10-15% weight loss and after the 2 year clinical program.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
phenotyping
Other intervention
Treatment groups
3,200 Participants
are divided into 1 treatment groupGroup A: Lifestyle intervention1 intervention
Trial outcomes
Primary outcomes
1
Phenotypic factors related to weight loss and long-term weight maintenance
Phenotypic factors include: blood glucose levels, lipomic/metabolomic measurements, genetic analysis, body fat percentage, maximal oxygen consumption, respiratory quotient, resting metabolic rate, physical/emotional health
Time frame
Change in phenotypic factors from baseline to 3-6 months and at 2 yearsSponsors and contacts
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Source ClinicalTrials.gov