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NCT Number: NCT02043457

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

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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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

phenotyping

Other

Other names: 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

Primary outcomes

  1. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Amy E Rothberg, MD, PhD

CONTACT

[email protected]

734-647-5871

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2009
Primary completion
2030
Study completion
2030
First posted
Jan 23, 2014
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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