Role Of Metabolic Adaptation In Weight Regain

Completed

• Conditions: Weight Loss; Weight Gain; Obesity
• Interventions: Behavioral: Intensive lifestyle change therapy; Drug: Tirzepatide

• Registration Number: NCT05766358
• Lead Sponsor: Pennington Biomedical Research Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-06
• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-03-02
• Study First Posted: 2023-03-13
• Primary Completion: 2024-05-24
• Study Completion: 2024-05-24
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Having participated in the study NCT04081337.

Exclusion Criteria

• Being pregnant.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo	Intensive lifestyle change therapy	-
Tirzepatide	Tirzepatide	-

Primary Outcome Measures

Name	Time	Method
Body weight	24 months

Secondary Outcome Measures

Name	Time	Method
Body weight	18 months
Body fat free mass (DXA)	24 months
Body fat mass (DXA)	24 months

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States