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OpenTrials
Completed

NCT Number: NCT05766358

Role Of Metabolic Adaptation In Weight Regain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70809, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having participated in the study NCT04081337.

Exclusion criteria

  • Being pregnant.

Treatment and study plan

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

Primary outcomes

  1. Body weight

    Time frame: 24 months

Secondary outcomes

  1. Body weight

    Time frame: 12 months

  2. Body weight

    Time frame: 18 months

  3. Body fat mass (DXA)

    Time frame: 12 months

  4. Body fat mass (DXA)

    Time frame: 18 months

  5. Body fat mass (DXA)

    Time frame: 24 months

  6. Body fat free mass (DXA)

    Time frame: 12 months

  7. Body fat free mass (DXA)

    Time frame: 18 months

  8. Body fat free mass (DXA)

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

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

Acronym: EXPEND-FU

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2023
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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