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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Puck van den Hooff
- Telefonnummer: 0031 30 698 60 90
- E-post: puck.vandenhooff@radboudumc.nl
Studer Kontakt Backup
- Navn: Jan Karregat
- E-post: jan.karregat@radboudumc.nl
Studiesteder
-
-
-
Amsterdam, Nederland
- Rekruttering
- NOK clinics
-
Ta kontakt med:
- Puck van den Hooff
- Telefonnummer: 0031 30 698 60 90
- E-post: pvandenhooff@obesitaskliniek.nl
-
Ta kontakt med:
- Valerie Monpellier
- E-post: vmonpellier@obesitaskliniek.nl
-
Nieuwegein, Nederland
- Har ikke rekruttert ennå
- NOK Clinics
-
Ta kontakt med:
- Valerie Monpellier
- E-post: vmonpellier@obesitaskliniek.nl
-
Ta kontakt med:
- Puck van den Hooff
- Telefonnummer: 0031 30 698 60 90
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
People with overweight or obesity
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
START-group
Participants who start with incretin treatment |
|
STOP-group
Participants who stop with incretin treatment |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The composition of weight loss during treatment
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Muscle strength
Tidsramme: 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
Tidsramme: 12 months
|
The Four Metre Walk Test and the Timed Chair-Stand_test will be performed to determine functional capacity. |
12 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical activity patterns
Tidsramme: 12 months
|
Habitual physical activity patterns will be objectively measured with a validated accelerometer. |
12 months
|
|
(Cardio)metabolic health
Tidsramme: 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
Tidsramme: 12 months
|
The performance of muscle resistance training will be assessed using the Muscle-Strengthening Exercise Questionnaire (MSEQ). |
12 months
|
|
Protein intake
Tidsramme: 12 months
|
Habitual dietary (protein) intake will be assessed using a Food Frequency Questionnaire (FFQ), a validated dietary assessment tool. |
12 months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NL-011099
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