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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02043457
• Other study ID #: HUM00030088
• Status: Recruiting
• Start date: August 2009
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: University of Michigan
• Contact: Amy E Rothberg, MD, PhD
• Phone: 734-647-5871
• Email: arothber[@]med.umich.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3200
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Other:
• phenotyping

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in phenotypic factors from baseline to 3-6 months and at 2 years

External Links

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