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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Puck van den Hooff
- 전화번호: 0031 30 698 60 90
- 이메일: puck.vandenhooff@radboudumc.nl
연구 연락처 백업
- 이름: Jan Karregat
- 이메일: jan.karregat@radboudumc.nl
연구 장소
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-
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Amsterdam, 네덜란드
- 모병
- NOK clinics
-
연락하다:
- Puck van den Hooff
- 전화번호: 0031 30 698 60 90
- 이메일: pvandenhooff@obesitaskliniek.nl
-
연락하다:
- Valerie Monpellier
- 이메일: vmonpellier@obesitaskliniek.nl
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Nieuwegein, 네덜란드
- 아직 모집하지 않음
- NOK Clinics
-
연락하다:
- Valerie Monpellier
- 이메일: vmonpellier@obesitaskliniek.nl
-
연락하다:
- Puck van den Hooff
- 전화번호: 0031 30 698 60 90
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
People with overweight or obesity
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
|---|
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START-group
Participants who start with incretin treatment |
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STOP-group
Participants who stop with incretin treatment |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The composition of weight loss during treatment
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Muscle strength
기간: 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
|
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Functional capacity
기간: 12 months
|
The Four Metre Walk Test and the Timed Chair-Stand_test will be performed to determine functional capacity. |
12 months
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Physical activity patterns
기간: 12 months
|
Habitual physical activity patterns will be objectively measured with a validated accelerometer. |
12 months
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(Cardio)metabolic health
기간: 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
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Performance of resistance training
기간: 12 months
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The performance of muscle resistance training will be assessed using the Muscle-Strengthening Exercise Questionnaire (MSEQ). |
12 months
|
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Protein intake
기간: 12 months
|
Habitual dietary (protein) intake will be assessed using a Food Frequency Questionnaire (FFQ), a validated dietary assessment tool. |
12 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .