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.
研究概览
地位
条件
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Puck van den Hooff
- 电话号码：0031 30 698 60 90
- 邮箱：puck.vandenhooff@radboudumc.nl
研究联系人备份
- 姓名：Jan Karregat
- 邮箱：jan.karregat@radboudumc.nl
学习地点
-
-
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Amsterdam、荷兰
- 招聘中
- NOK clinics
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接触：
- Puck van den Hooff
- 电话号码：0031 30 698 60 90
- 邮箱：pvandenhooff@obesitaskliniek.nl
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接触：
- Valerie Monpellier
- 邮箱：vmonpellier@obesitaskliniek.nl
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Nieuwegein、荷兰
- 尚未招聘
- NOK Clinics
-
接触：
- Valerie Monpellier
- 邮箱：vmonpellier@obesitaskliniek.nl
-
接触：
- Puck van den Hooff
- 电话号码：0031 30 698 60 90
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
People with overweight or obesity
描述
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.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
|---|
|
START-group
Participants who start with incretin treatment |
|
STOP-group
Participants who stop with incretin treatment |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The composition of weight loss during treatment
大体时间：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
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Muscle strength
大体时间：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
大体时间：12 months
|
The Four Metre Walk Test and the Timed Chair-Stand_test will be performed to determine functional capacity. |
12 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Physical activity patterns
大体时间：12 months
|
Habitual physical activity patterns will be objectively measured with a validated accelerometer. |
12 months
|
|
(Cardio)metabolic health
大体时间：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
大体时间：12 months
|
The performance of muscle resistance training will be assessed using the Muscle-Strengthening Exercise Questionnaire (MSEQ). |
12 months
|
|
Protein intake
大体时间：12 months
|
Habitual dietary (protein) intake will be assessed using a Food Frequency Questionnaire (FFQ), a validated dietary assessment tool. |
12 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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