Weight LossEXPEND-FUNCT05766358
Role Of Metabolic Adaptation In Weight Regain
An observational study of Weight Loss and Weight Gain, run by Pennington Biomedical Research Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss, Weight Gain, Obesity
- What is being tested?
- Intensive lifestyle change therapy and Tirzepatide
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2022to 24 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants having completed the NCT04081337 study.
Who may be able to join
- Having participated in the study NCT04081337.
Who cannot join
- Being pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70809
About this study
Official title: Role Of Metabolic Adaptation In Weight Regain: Expend Follow-Up
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.
- Conditions
- Weight Loss, Weight Gain, Obesity
- Being tested
- Intensive lifestyle change therapy, Tirzepatide
- Medical subject headings
- Weight Loss, Weight Gain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive lifestyle change therapyBehavioural
Participant of both groups will be followed for 24 months after completing the parent trial intervention, with no intervention during the follow-up
TirzepatideDrug
Participant of both groups will be followed for 24 months after completing the parent trial intervention, with no intervention during the follow-up
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Not described Receives: Behavioral: Intensive lifestyle change therapy | |
| Tirzepatide | Not described Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured: 24 months
Secondary outcomes (8)
Body weight
Measured: 12 months
Body weight
Measured: 18 months
Body fat mass (DXA)
Measured: 12 months
Body fat mass (DXA)
Measured: 18 months
Body fat mass (DXA)
Measured: 24 months
Body fat free mass (DXA)
Measured: 12 months
Body fat free mass (DXA)
Measured: 18 months
Body fat free mass (DXA)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start6 Oct 2022
- Primary completion24 May 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Ravussin, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766358
- Sponsor's protocol ID
- PBRC 2022-027
- Acronym
- EXPEND-FU
- Status last verified
- Jun 2024
- First submitted
- 21 Feb 2023
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Of Metabolic Adaptation In Weight Regain: Expend Follow-Up
- ClinicalTrials.gov ID
- NCT05766358
- Acronym / sponsor ID
- EXPEND-FU / PBRC 2022-027
- Conditions
- Weight Loss, Weight Gain, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | – | Behavioral: Intensive lifestyle change therapy |
| Tirzepatide | – | Drug: Tirzepatide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants having completed the NCT04081337 study.
Key inclusion criteria (1 listed)
- Having participated in the study NCT04081337.
Key exclusion criteria (1 listed)
- Being pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive lifestyle change therapyParticipant of both groups will be followed for 24 months after completing the parent trial intervention, with no intervention during the follow-up | Behavioural | Placebo |
| TirzepatideParticipant of both groups will be followed for 24 months after completing the parent trial intervention, with no intervention during the follow-up | Drug | Tirzepatide |
Primary outcome
Body weight
Time frame: 24 months
8 secondary outcomes
Body weight
Time frame: 12 months
Body weight
Time frame: 18 months
Body fat mass (DXA)
Time frame: 12 months
Body fat mass (DXA)
Time frame: 18 months
Body fat mass (DXA)
Time frame: 24 months
Body fat free mass (DXA)
Time frame: 12 months
Body fat free mass (DXA)
Time frame: 18 months
Body fat free mass (DXA)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Loss and Weight Gain, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.