Trials / Completed
CompletedNCT05766358
Role Of Metabolic Adaptation In Weight Regain
Role Of Metabolic Adaptation In Weight Regain: Expend Follow-Up
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 27 (actual)
- Sponsor
- Pennington Biomedical Research Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Intensive lifestyle change therapy | Participant of both groups will be followed for 24 months after completing the parent trial intervention, with no intervention during the follow-up |
| DRUG | Tirzepatide | Participant of both groups will be followed for 24 months after completing the parent trial intervention, with no intervention during the follow-up |
Timeline
- Start date
- 2022-10-06
- Primary completion
- 2024-05-24
- Completion
- 2024-05-24
- First posted
- 2023-03-13
- Last updated
- 2024-06-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05766358. Inclusion in this directory is not an endorsement.