Risk of Metabolic Adaptation After Weight Loss
Biomarkers of Increased Risk of Developing Metabolic Adaptation to Weight Loss
1 other identifier
interventional
60
1 country
1
Brief Summary
This study aims at identifying the neurohormonal biomarkers that characterize individuals at risk of greater metabolic adaptation to weight loss, a disproportionate decline in resting metabolic rate during and after weight loss.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2021
CompletedFirst Posted
Study publicly available on registry
December 1, 2021
CompletedStudy Start
First participant enrolled
September 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2031
February 11, 2026
February 1, 2026
9.1 years
November 18, 2021
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in measured and predicted resting metabolic rate during and after weight loss
resting metabolic rate will be measured by indirect calorimetry every 2 months for 6 months, then every 6 months for an additional 12 month. Predicted resting metabolic rate will be calculated with a mathematical formula at the same time points
18 months
Secondary Outcomes (7)
change in circulating leptin during and after weight loss
18 months
change in circulating thyroid hormones during and after weight loss
18 months
change in circulating GLP-1 during and after weight loss
18 months
change in circulating PYY during and after weight loss
18 months
change in circulating AgRP during and after weight loss
18 months
- +2 more secondary outcomes
Study Arms (1)
lifestyle intervention
EXPERIMENTALParticipants will be enrolled in a weight loss program based on lifestyle changes. They will be given a 6-month subscription to a calorie-reduced meal replacement program that also offers lifestyle coaching.
Interventions
participants will be enrolled in a medical weight loss program and will be given a 6 month subscription to a calorie-reduced meal replacement program, in addition to lifestyle advice.
Eligibility Criteria
You may qualify if:
- BMI \> or = 30 any ethnicity
You may not qualify if:
- weight \> or = 400 lbs.
- diabetes (type 2 or type 1)
- hypertension
- heart disease
- kidney disease
- liver disease
- active cancer
- post solid organ or bone marrow transplant
- HIV/AIDS
- pregnancy
- breastfeeding
- current smoker
- current recreational drug use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa L Morselli, MD PhD
Medical College of Wisconsin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
November 18, 2021
First Posted
December 1, 2021
Study Start
September 10, 2022
Primary Completion (Estimated)
November 1, 2031
Study Completion (Estimated)
November 1, 2031
Last Updated
February 11, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share