The Impact of Incretins on Fat-free Mass, Muscle Strength and Functional Capacity (IMPACT)
Uncovering the Impact of Incretins on Fat-free Mass, Muscle Strength and Functional Capacity: an Observational Prospective Cohort
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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Puck van den Hooff
- Numero di telefono: 0031 30 698 60 90
- Email: puck.vandenhooff@radboudumc.nl
Backup dei contatti dello studio
- Nome: Jan Karregat
- Email: jan.karregat@radboudumc.nl
Luoghi di studio
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Amsterdam, Olanda
- Reclutamento
- NOK clinics
-
Contatto:
- Puck van den Hooff
- Numero di telefono: 0031 30 698 60 90
- Email: pvandenhooff@obesitaskliniek.nl
-
Contatto:
- Valerie Monpellier
- Email: vmonpellier@obesitaskliniek.nl
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Nieuwegein, Olanda
- Non ancora reclutamento
- NOK Clinics
-
Contatto:
- Valerie Monpellier
- Email: vmonpellier@obesitaskliniek.nl
-
Contatto:
- Puck van den Hooff
- Numero di telefono: 0031 30 698 60 90
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
People with overweight or obesity
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
|---|
|
START-group
Participants who start with incretin treatment |
|
STOP-group
Participants who stop with incretin treatment |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The composition of weight loss during treatment
Lasso di tempo: 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). |
12 months
|
|
The composition of recurrent weight gain after cessation of treatment
Lasso di tempo: 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). |
12 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Muscle strength
Lasso di tempo: 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. |
12 months
|
|
Functional capacity
Lasso di tempo: 12 months
|
The Four Metre Walk Test and the Timed Chair-Stand_test will be performed to determine functional capacity. |
12 months
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Physical activity patterns
Lasso di tempo: 12 months
|
Habitual physical activity patterns will be objectively measured with a validated accelerometer. |
12 months
|
|
(Cardio)metabolic health
Lasso di tempo: 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). |
12 months
|
|
Performance of resistance training
Lasso di tempo: 12 months
|
The performance of muscle resistance training will be assessed using the Muscle-Strengthening Exercise Questionnaire (MSEQ). |
12 months
|
|
Protein intake
Lasso di tempo: 12 months
|
Habitual dietary (protein) intake will be assessed using a Food Frequency Questionnaire (FFQ), a validated dietary assessment tool. |
12 months
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NL-011099
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