Role Of Metabolic Adaptation In Weight Regain

Obesity Clinical Trial

— EXPEND-FU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05766358
• Other study ID #: PBRC 2022-027
• Status: Completed
• Start date: October 6, 2022
• Est. completion date: May 24, 2024

Study information

• Verified date: June 2024
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 24, 2024
• Est. primary completion date: May 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Having participated in the study NCT04081337.

Exclusion Criteria:

• Being pregnant.

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Weight Gain
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight		24 months
Secondary	Body weight		12 months
Secondary	Body weight		18 months
Secondary	Body fat mass (DXA)		12 months
Secondary	Body fat mass (DXA)		18 months
Secondary	Body fat mass (DXA)		24 months
Secondary	Body fat free mass (DXA)		12 months
Secondary	Body fat free mass (DXA)		18 months
Secondary	Body fat free mass (DXA)		24 months