Identification of Phenotypic Factors That Predict Success for Weight Loss and Long-term Weight Maintenance

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

3200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

phenotyping

Intervention Type OTHER

Interventions

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phenotyping

Intervention Type OTHER

Other Intervention Names

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Phentoyping includes: Health related quality of life questionnaires Depression Inventory Work Performance Resting Energy Expenditure measured by indirect calorimetry Oxidative Capacity measured by V02 max Body composition measured by Dual Energy X-ray Absorptiometry (DEXA) or air displacement plethysmograph (Bod Pod) Mixed Meal Tolerance Testing with metabolomic profiling and hormone evaluation Oral Glucose Tolerance Testing DNA RNA Muscle biopsy (from vastus lateralis) Adipose tissue biopsy from abdomen Survey regarding pain

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
* Participation in any other clinical trial within 90 days of entry into this trial.
* Pregnant or lactating females.
* Uncontrolled thyroid disease
* Unstable angina or NY heart association class II failure or above
* Gastrointestinal disease specifically GI motility disorders
* Unstable neuropsychiatric disease including major depression/anxiety, eating disorder such as binge eating, bulimia or anorexia
* End stage renal or hepatic disease
* Autoimmune disorders (e.g. SLE)
* Body weight fluctuation of more than 5 kg in the previous 3 months
* Prior bariatric surgery
* A history or current alcohol/substance abuse and change in smoking habits or cessation in the past 6 months.
* Women of childbearing age must use a reliable form of contraception.
* Any medical condition, which in the opinion of the investigator would make the patient unsuitable for recruitment, or could interfere with the patient participating in or completing the protocol.
* Unwilling or unable to consent for the study.

Minimum Eligible Age

15 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes