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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Puck van den Hooff
- Numéro de téléphone: 0031 30 698 60 90
- E-mail: puck.vandenhooff@radboudumc.nl
Sauvegarde des contacts de l'étude
- Nom: Jan Karregat
- E-mail: jan.karregat@radboudumc.nl
Lieux d'étude
-
-
-
Amsterdam, Pays-Bas
- Recrutement
- NOK clinics
-
Contact:
- Puck van den Hooff
- Numéro de téléphone: 0031 30 698 60 90
- E-mail: pvandenhooff@obesitaskliniek.nl
-
Contact:
- Valerie Monpellier
- E-mail: vmonpellier@obesitaskliniek.nl
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Nieuwegein, Pays-Bas
- Pas encore de recrutement
- NOK Clinics
-
Contact:
- Valerie Monpellier
- E-mail: vmonpellier@obesitaskliniek.nl
-
Contact:
- Puck van den Hooff
- Numéro de téléphone: 0031 30 698 60 90
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
People with overweight or obesity
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
|---|
|
START-group
Participants who start with incretin treatment |
|
STOP-group
Participants who stop with incretin treatment |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The composition of weight loss during treatment
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Muscle strength
Délai: 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
Délai: 12 months
|
The Four Metre Walk Test and the Timed Chair-Stand_test will be performed to determine functional capacity. |
12 months
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Physical activity patterns
Délai: 12 months
|
Habitual physical activity patterns will be objectively measured with a validated accelerometer. |
12 months
|
|
(Cardio)metabolic health
Délai: 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
Délai: 12 months
|
The performance of muscle resistance training will be assessed using the Muscle-Strengthening Exercise Questionnaire (MSEQ). |
12 months
|
|
Protein intake
Délai: 12 months
|
Habitual dietary (protein) intake will be assessed using a Food Frequency Questionnaire (FFQ), a validated dietary assessment tool. |
12 months
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NL-011099
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