Role Of Metabolic Adaptation In Weight Regain (EXPEND-FU)

May 3, 2024 updated by: Eric Ravussin, Pennington Biomedical Research Center

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants having completed the NCT04081337 study.

Description

Inclusion Criteria:

  • Having participated in the study NCT04081337.

Exclusion Criteria:

  • Being pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Placebo
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
Tirzepatide
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: 18 months
18 months
Body weight
Time Frame: 12 months
12 months
Body fat mass (DXA)
Time Frame: 12 months
12 months
Body fat mass (DXA)
Time Frame: 18 months
18 months
Body fat mass (DXA)
Time Frame: 24 months
24 months
Body fat free mass (DXA)
Time Frame: 12 months
12 months
Body fat free mass (DXA)
Time Frame: 18 months
18 months
Body fat free mass (DXA)
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2022

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBRC 2022-027

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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