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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intensive lifestyle change therapy — BEHAVIORAL
    Participant of both groups will be followed for 24 months after completing the parent trial intervention, with no intervention during the follow-up
  • Tirzepatide — DRUG
    Participant 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)

FacilityCityStateZIPSite coordinators
Pennington Biomedical Research CenterBaton RougeLouisiana70809-

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