Role Of Metabolic Adaptation In Weight Regain

What this study is testing ClinicalTrials.gov NCT05766358 ↗

Description as written by the study sponsor.

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.

Treatments tested

• Intensive lifestyle change therapy 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 Drug

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