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RecruitingNCT07929831ClinicalTrials.gov record

The Impact of Incretins on Fat-free Mass, Muscle Strength and Functional Capacity

Obesity & Overweight

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type
Observational
Phase
Not applicable / not listed
Age range
18 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
200 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The goal of this observational study is to learn how treatment with incretins, such as semaglutide and tirzepatide, affects muscle mass, muscle strength, and physical function in people with overweight or obesity.

The main questions this study aims to answer are:

  • What is the composition of weight loss during incretin treatment?
  • What is the composition of recurrent weight gain after stopping incretin treatment?

An additional question this study aims to answer is:

\- How do muscle strength and physical function change during and after incretin treatment?

Two groups of patients will be included: patients who start with incretin therapy for overweight/obesity and patients who stop incretin therapy for overweight/obesity.

Participants who start incretin treatment will have measurements before starting treatment, after six months, and after twelve months or when treatment is stopped. Participants who stop incretin treatment will have measurements before stopping treatment, after six months, and after twelve months or before restarting treatment.

Measurements include:

  • Height, length, waist circumference
  • Body composition measured with InBody, with a Dual-Energy X-ray Absorptiometry in a subgroup of the participants
  • Muscle strength tests
  • Physical function tests
  • Blood samples to asses metabolic health
  • Physical activity measured with an activity monitor (ActivPAL)
  • Questionnaires about health, incretin treatment, physical activity, and diet

No treatment or medication will be given as part of the study. Participants will receive incretin treatment as part of their usual care.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

  • Screened and planned to start with incretin treatment or currently using incretin and planned to discontinue treatment.
  • Aged 18 years or older

Exclusion Criteria:

  • Inability to comprehend scheduled procedures (e.g., language barriers)
  • Unable to perform the physical tests due to physical disabilities
  • Patients who underwent MBS or including endoscopic interventions and gastric balloon placement.
  • Prior use of incretins, or other obesity medication.

Study population

People with overweight or obesity

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not reported
Masking
Not reported
START-group

Participants who start with incretin treatment

STOP-group

Participants who stop with incretin treatment

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

The composition of weight loss during treatment

Time frame: 12 months

Ratio of fat-free mass (FFM) to total weight loss. FFM will be measured using a InBody Bioelectrical Impedance Analysis (BIA) and a Dual-Energy X-ray Absorptiometry (in a subgroup).

The composition of recurrent weight gain after cessation of treatment

Time frame: 12 months

The ratio of fat-free mass (FFM) to recurrent weight gain. FFM will be measured using a InBody Bioelectrical Impedance Analysis (BIA) and a Dual-Energy X-ray Absorptiometry (in a subgroup).

Secondary measures

Muscle strength

Time frame: 12 months

Maximal handgrip strength will be measured using a hand dynamometer. An isometric strength test will be used to determine maximum strength and maximum power using a leg extension machine.

Functional capacity

Time frame: 12 months

The Four Metre Walk Test and the Timed Chair-Stand\_test will be performed to determine functional capacity.

Other measures

Physical activity patterns

Time frame: 12 months

Habitual physical activity patterns will be objectively measured with a validated accelerometer.

(Cardio)metabolic health

Time frame: 12 months

Non-fasted venous blood samples will be drawn to provide information on glycated hemoglobin (HbA1c), lipid profile (Total Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides), high-sensitivity C-reactive protein (hs-CRP) and creatine kinase (CK).

Performance of resistance training

Time frame: 12 months

The performance of muscle resistance training will be assessed using the Muscle-Strengthening Exercise Questionnaire (MSEQ).

Protein intake

Time frame: 12 months

Habitual dietary (protein) intake will be assessed using a Food Frequency Questionnaire (FFQ), a validated dietary assessment tool.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (2)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

2 locations

NOK clinicsAmsterdam, NetherlandsRecruiting
NOK ClinicsNieuwegein, NetherlandsNot yet recruiting
Puck van den HooffCONTACT0031 30 698 60 90
Valerie MonpellierCONTACTvmonpellier@obesitaskliniek.nl
View location on map ↗

Study team and timeline

Lead sponsor
Radboud University Medical Center
Study start
Aug 28, 2026 Actual
Primary completion
Feb 1, 2027 Estimated
Study completion
Mar 1, 2027 Estimated
First posted
Nov 10, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

Jan KarregatCONTACTjan.karregat@radboudumc.nl
Official study title

Uncovering the Impact of Incretins on Fat-free Mass, Muscle Strength and Functional Capacity: an Observational Prospective Cohort

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026