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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Other: phenotyping

• Study Type: Observational
• Enrollment (Estimated): 3200

Contacts and Locations

• Study Contact: Name: Amy E Rothberg, MD, PhD; Phone Number: 734-647-5871; Email: arothber@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Recruiting
      • University of Michigan
      • Contact: Amy E Rothberg, MD, PhD; Phone Number: 734-647-5871; Email: arothber@med.umich.edu
      • Contact: Nicole Miller, MPH, RD; Phone Number: 734-232-3587; Email: npiazza@med.umich.edu
      • Principal Investigator: Amy E Rothberg, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 71 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Study Director: Charles Burant, MD, PhD, University of Michigan

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 17, 2014
• First Submitted That Met QC Criteria: January 21, 2014
• First Posted (Estimated): January 23, 2014

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; Diagnostic Imaging; Chemistry Techniques, Analytical; Immunologic Techniques; Radiography; Densitometry; Photometry; Immunologic Tests; Absorptiometry, Photon; DNA; Immunophenotyping; RNA
• Other Study ID Numbers: HUM00030088