Role Of Metabolic Adaptation In Weight Regain

NCT ID: NCT05766358

Last Updated: 2024-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-06

Study Completion Date

2024-05-24

Brief Summary

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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.

Detailed Description

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Conditions

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Weight Loss Weight Gain Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Placebo

Intensive lifestyle change therapy

Intervention Type 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

Tirzepatide

Intervention Type DRUG

Participant of both groups will be followed for 24 months after completing the parent trial intervention, with no intervention during the follow-up

Interventions

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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

Intervention Type BEHAVIORAL

Tirzepatide

Participant of both groups will be followed for 24 months after completing the parent trial intervention, with no intervention during the follow-up

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Having participated in the study NCT04081337.

Exclusion Criteria

* Being pregnant.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Eric Ravussin

Associate Executive Director for Clinical Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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PBRC 2022-027

Identifier Type: -

Identifier Source: org_study_id

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