Recruiting

Observational Study

Sponsor:

University of Michigan

Code:

NCT02043457

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 15 - 70+

Healthy Volunteers: Accepted

Interventions

phenotyping

Study Details

Brief summary:

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.

Conditions

Obesity

Study ID

NCT02043457

Start date

Aug, 2009

Status verified date

Jul, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

3200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

phenotyping

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 and Locations

Central contacts

Amy E Rothberg, MD, PhD

734-647-5871arothber@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48106

Contacts

Amy E Rothberg, MD, PhD

734-647-5871arothber@med.umich.edu

Nicole Miller, MPH, RD

734-232-3587npiazza@med.umich.edu

Principal Investigator:

Amy E Rothberg, MD, PhD

More Information

Sponsor

University of Michigan

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-07-13.