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Clinical Trials/NCT05766358
NCT05766358CompletedNot Applicable

Role Of Metabolic Adaptation In Weight Regain: Expend Follow-Up

Pennington Biomedical Research Center1 site in 1 country27 target enrollmentStarted: October 6, 2022Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
27
Locations
1
Primary Endpoint
Body weight

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Having participated in the study NCT04081337.

Exclusion Criteria

  • Being pregnant.

Arms & Interventions

Placebo

Intervention: Intensive lifestyle change therapy (Behavioral)

Tirzepatide

Intervention: Tirzepatide (Drug)

Outcomes

Primary Outcomes

Body weight

Time Frame: 24 months

Secondary Outcomes

  • Body weight(18 months)
  • Body fat free mass (DXA)(24 months)
  • Body fat mass (DXA)(24 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eric Ravussin

Associate Executive Director for Clinical Science

Pennington Biomedical Research Center

Study Sites (1)

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