Role Of Metabolic Adaptation In Weight Regain
EXPEND-FU
1 other identifier
observational
27
1 country
1
Brief Summary
In a previous study (NCT04081337), 55 participants with obesity participated on a 18-week lifestyle intervention to reduce their body weight, targeting 10% body weight loss. The participants received tirzepatide (15mg after titration) or placebo during the weight loss intervention. Before and after the lifestyle intervention, energy expenditure (48-h room indirect calorimetry) and body weight and composition (dual-X-ray absorptiometry) were measured, thus enabling the assessment of metabolic adaptation. In this study, participants having provided their consent to be re-contacted will be invited to attend the research center 12,18 and 24 months after completing the lifestyle intervention. Body weight and composition will be measured, aiming to explore the association between metabolic adaptation and changes in body weight and composition after a weight loss intervention. In addition, we will explore whether weight and fat mass changes are different between groups, and whether these effects are mediated by metabolic adaptation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2022
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
Study Start
First participant enrolled
October 6, 2022
CompletedFirst Submitted
Initial submission to the registry
February 21, 2023
CompletedFirst Posted
Study publicly available on registry
March 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2024
CompletedJune 10, 2024
June 1, 2024
1.6 years
February 21, 2023
June 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Body weight
24 months
Secondary Outcomes (8)
Body weight
12 months
Body weight
18 months
Body fat mass (DXA)
12 months
Body fat mass (DXA)
18 months
Body fat mass (DXA)
24 months
- +3 more secondary outcomes
Study Arms (2)
Placebo
Tirzepatide
Interventions
Participant of both groups will be followed for 24 months after completing the parent trial intervention, with no intervention during the follow-up
Participant of both groups will be followed for 24 months after completing the parent trial intervention, with no intervention during the follow-up
Eligibility Criteria
Participants having completed the NCT04081337 study.
You may qualify if:
- Having participated in the study NCT04081337.
You may not qualify if:
- Being pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70809, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Executive Director for Clinical Science
Study Record Dates
First Submitted
February 21, 2023
First Posted
March 13, 2023
Study Start
October 6, 2022
Primary Completion
May 24, 2024
Study Completion
May 24, 2024
Last Updated
June 10, 2024
Record last verified: 2024-06