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Role Of Metabolic Adaptation In Weight Regain

NCT05766358 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 27

Last updated 2024-06-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Pennington Biomedical Research Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-06
Primary Completion
2024-05-24
Completion
2024-05-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05766358 on ClinicalTrials.gov