Role Of Metabolic Adaptation In Weight Regain
Part of paid clinical trials in Baton Rouge, Louisiana.
- Sponsor
- Pennington Biomedical Research Center
- Study ID
- NCT05766358
- Status
- Completed
Conditions
- Obesity
- Weight Gain
- Weight Loss
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Intensive lifestyle change therapy — BEHAVIORALParticipant of both groups will be followed for 24 months after completing the parent trial intervention, with no intervention during the follow-up
- Tirzepatide — DRUGParticipant of both groups will be followed for 24 months after completing the parent trial intervention, with no intervention during the follow-up
Study Details
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.
Key Dates
- Start date
- Oct 6, 2022
- Status verified
- Jun 2024
- Primary completion
- May 24, 2024
- Completion
- May 24, 2024
Study Design
- Enrollment
- 27 participants (actual)
Arms
- Arm: Placebo
- Arm: Tirzepatide
Primary Outcome Measure
Body weight [ Time Frame: 24 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70809 | - |
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