Role Of Metabolic Adaptation In Weight Regain

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05766358

Acronym

EXPEND-FU

Enrollment

Registered

2023-03-13

Start date

2022-10-06

Completion date

2024-05-24

Last updated

2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Weight Gain, Weight Loss

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.

Interventions

BEHAVIORALIntensive 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

DRUGTirzepatide

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Having participated in the study NCT04081337.

Exclusion criteria

* Being pregnant.

Design outcomes

Primary

Measure	Time frame
Body weight	24 months

Secondary

Measure	Time frame
Body weight	12 months
Body fat mass (DXA)	12 months
Body fat free mass (DXA)	12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026