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

NCT02043457 | Recruiting

• 1 other identifier: HUM00030088
• Study Type: observational
• Target: 3,200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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

  Change in phenotypic factors from baseline to 3-6 months and at 2 years

Study Arms (1)

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.

Other: phenotyping

Interventions

phenotyping OTHER

Also known as: 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

Lifestyle intervention

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48106, United States

RECRUITING

Related Publications (2)

• Rothberg AE, Marriott DJ, Miller NM, Herman WH. Retention and weight outcomes after transitioning an intensive behavioral weight management program from an in-person to a virtual format. Obes Sci Pract. 2023 Apr 20;9(5):452-458. doi: 10.1002/osp4.673. eCollection 2023 Oct.

  PMID: 37810529 DERIVED

• Rothberg AE, McEwen LN, Kraftson AT, Fowler CE, Herman WH. Very-low-energy diet for type 2 diabetes: an underutilized therapy? J Diabetes Complications. 2014 Jul-Aug;28(4):506-10. doi: 10.1016/j.jdiacomp.2014.03.014. Epub 2014 Mar 29.

  PMID: 24849710 DERIVED

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

DNA that is de-indentified is stored.

MeSH Terms

Conditions

Obesity

Interventions

Immunophenotyping; Absorptiometry, Photon; DNA; RNA

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Radiography; Diagnostic Imaging; Densitometry; Photometry; Chemistry Techniques, Analytical; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Charles Burant, MD, PhD

  University of Michigan

  STUDY DIRECTOR

Central Study Contacts

Amy E Rothberg, MD, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 23, 2014
• Study Start: August 1, 2009
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2024-09

Locations

US (1)