Effectiveness of Combined GLP-1/GIP Dual Agonist Therapy and Structured Exercise on Skeletal Muscle Morphology, Quality, and Physical Function in Overweight and Obese Individuals
2026年6月3日 更新者：Özgül Öztürk、Acibadem University
Effectiveness of Combined GLP-1/GIP Dual Agonist Therapy and Structured Exercise on Skeletal Muscle Morphology, Quality, and Physical Function in Overweight and Obese Individuals: a Randomized Controlled Trial Protocol
This randomized controlled trial aims to investigate the effects of a 24-week home-based progressive resistance exercise program combined with tirzepatide treatment on skeletal muscle mass, muscle quality, and functional capacity in overweight and obese individuals.
A total of 108 participants initiating tirzepatide therapy will be randomized to either exercise plus pharmacotherapy or pharmacotherapy alone.
The primary outcome is change in thigh muscle thickness and echo intensity assessed by ultrasonography.
研究概览
详细说明
Pharmacologically induced weight loss with glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) receptor agonists such as tirzepatide is associated with significant reductions in lean body mass, raising concerns regarding muscle function and long-term outcomes. Resistance exercise is the most effective intervention to preserve muscle mass during weight loss; however, evidence combining these approaches is limited.
This study is a prospective, two-center, single-blinded, randomized controlled trial designed to evaluate whether structured resistance exercise enhances muscle preservation and functional outcomes in individuals receiving tirzepatide therapy.
研究类型
介入性
注册 (估计的)
108
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Özgül Öztürk, Associate Professor
- 电话号码：902165004185
- 邮箱：ozgul.ozturk@acibadem.edu.tr
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- initiation of tirzepatide-based pharmacological treatment as prescribed by an endocrinology and metabolism specialist,
- body mass index (BMI) ≥27 kg/m² and the presence of a comorbidity condition or BMI≥30 kg/m²
- age between 18 and 65 years
Exclusion Criteria:
- diagnosis of type 1 or type 2 diabetes mellitus
- presence of cerebrovascular, hematological, pulmonary, rheumatological, or neurological disorders
- current participation in a structured diet or exercise program
- use of weight-loss medications within the past 12 months
- history of upper or lower extremity surgery or injury within the past 6 months
- any contraindication to resistance exercise as determined by the treating physician.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Resistance Exercise + Tirzepatide
24-week home-based progressive resistance exercise program (3 sessions/week) using elastic bands and bodyweight exercises, combined with tirzepatide treatment and general lifestyle recommendations..
|
A 24-week home-based resistance exercises using elastic band and bodyweight
Lifestyle recommendations including physical activity and nutritional advice
|
|
有源比较器：Tirzepatide Alone
Standard tirzepatide treatment with usual care and general lifestyle recommendations.
|
Lifestyle recommendations including physical activity and nutritional advice
|
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 |
|---|---|---|
|
Change in muscle thickness
大体时间：Baseline, 12 weeks, 24 weeks
|
Muscle thickness of the thigh (quadriceps femoris) will be assessed using a portable ultrasound and will be presented in millimeters (mm).
|
Baseline, 12 weeks, 24 weeks
|
|
Muscle echo intensity
大体时间：Baseline, 12 weeks, 24 weeks
|
Echo intensity will be assessed via a portable muscle ultrasonography using grayscale analysis (0-255 scale) within a standardized region of interest using ImageJ software (National Institutes of Health, USA), with higher values indicating greater intramuscular fat and fibrous tissue infiltration and thus poorer muscle quality.
Assessments will include quadriceps femoris.
|
Baseline, 12 weeks, 24 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Muscle strength (handheld dynamometer)
大体时间：Baseline, 12 weeks, 24 weeks
|
Isometric muscle strength of the biceps brachii, triceps brachii, quadriceps femoris, and hamstrings will be assessed bilaterally using a Lafayette handheld dynamometer (Lafayette Instrument Company®, USA) using the make test method.
|
Baseline, 12 weeks, 24 weeks
|
|
Body weight
大体时间：Baseline, 12 weeks, 24 weeks
|
Body weight will be assessed using bioelectrical impedance analysis and presented in kilograms (kg).
|
Baseline, 12 weeks, 24 weeks
|
|
Six-minute walk test
大体时间：Baseline, 12 weeks, 24 weeks
|
Functional capacity will be assessed using the 6-minute walk test according to standardized procedures and the total distance will be recorded in meters.
|
Baseline, 12 weeks, 24 weeks
|
|
Physical activity
大体时间：Baseline, 12 weeks, 24 weeks
|
Physical activity will be measured objectively using a wearable device (Garmin Vívosmart 5), time spent for light, moderate, and vigorous activity will be recorded for 7 days.
|
Baseline, 12 weeks, 24 weeks
|
|
Nutritional status (3-day food record)
大体时间：Baseline, 12 weeks, 24 weeks
|
Dietary intake will be assessed at baseline, 12 weeks, and 24 weeks using 3-day food records (two non-consecutive weekdays and one weekend day).
Prior to assessment, participants will receive standardized verbal, written, and visual instructions - including portion size estimation aids - to ensure accurate and consistent recording.
|
Baseline, 12 weeks, 24 weeks
|
|
Quality of life (Short Form-36)
大体时间：Baseline, 12 weeks, 24 weeks
|
The Short Form-36, a validated and reliable self-reported instrument evaluating physical and mental health status across eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health will be used to determine the level of quality of life.
Physical and mental sub scales are scored from 0 to 100, higher scores indicate a better quality of life.
|
Baseline, 12 weeks, 24 weeks
|
|
Clinical parameters (blood pressure)
大体时间：Baseline, 12 weeks, 24 weeks
|
Blood pressure will be measured using a sphygmomanometer at each assessment point.
|
Baseline, 12 weeks, 24 weeks
|
|
Height
大体时间：Baseline, 12 weeks, 24 weeks
|
Height of the participants will be assessed using a stadiometer and presented in meters.
|
Baseline, 12 weeks, 24 weeks
|
|
Body mass index
大体时间：Baseline, 12 weeks, 24 weeks
|
Body mass index will be calculated using height and weight (kg/m^2)
|
Baseline, 12 weeks, 24 weeks
|
|
Body fat percentage
大体时间：Baseline, 12 weeks, 24 weeks
|
Body fat percentage will be assessed using bioelectrical impedance analysis and presented in percentage (%).
|
Baseline, 12 weeks, 24 weeks
|
|
Fat free mass
大体时间：Baseline, 12 weeks, 24 weeks
|
Fat-free mass will be assessed using bioelectrical impedance analysis and presented in kilograms.
|
Baseline, 12 weeks, 24 weeks
|
|
Chair stand test
大体时间：Baseline, 12 weeks, 24 weeks
|
Functional capacity will be assessed using 30-second chair stand test according to standardized procedures.
The number of repetitions which the participants fully raised from a chair will be recorded in numbers (n).
|
Baseline, 12 weeks, 24 weeks
|
|
Self-reported physical activity
大体时间：Baseline, 12 weeks, 24 weeks
|
Self-reported physical activity will be determined using the International Physical Activity Questionnaire-Short Form (IPAQ-SF).
Metabolic equivalent (MET) values will be calculated and participants will be categorized into inactive, moderately active, and very active based on MET values.
|
Baseline, 12 weeks, 24 weeks
|
|
Grip strength
大体时间：Baseline, 12 weeks, 24 weeks
|
Handgrip strength will be assessed using a JAMAR dynamometer (Sammons Preston, USA) following the standardized protocol.
Three maximal isometric contractions will be performed with 1-minute rest intervals, the mean of the three trials in kilograms will be used for analysis.
|
Baseline, 12 weeks, 24 weeks
|
|
Clinical measures (fasting glucose)
大体时间：Baseline, 12 weeks, 24 weeks
|
Fasting glucose will be recorded from the medical records and will be presented in mmol/L.
|
Baseline, 12 weeks, 24 weeks
|
|
Clinical parameters (lipid profile)
大体时间：Baseline, 12 weeks, 24 weeks
|
Total Cholesterol, LDL (Low-Density Lipoprotein) Cholesterol, HDL (High-Density Lipoprotein) Cholesterol, Triglycerides will be recorded from the medical records and presented in mmol/L.
|
Baseline, 12 weeks, 24 weeks
|
|
Muscle thickness
大体时间：Baseline, 12 weeks, 24 weeks
|
Muscle thickness of the biceps femoris, triceps brachii, and biceps brachia will be assessed using a portable ultrasound and will be presented in millimeters (mm).
|
Baseline, 12 weeks, 24 weeks
|
|
Muscle echo intensity
大体时间：Baseline, 12 weeks, 24 weeks
|
Echo intensity will be assessed via a portable muscle ultrasonography using grayscale analysis (0-255 scale) within a standardized region of interest using ImageJ software (National Institutes of Health, USA), with higher values indicating greater intramuscular fat and fibrous tissue infiltration and thus poorer muscle quality.
Assessments will include biceps femoris, biceps brachii, and triceps brachii.
|
Baseline, 12 weeks, 24 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年11月1日
初级完成 (估计的)
2027年11月30日
研究完成 (估计的)
2028年1月1日
研究注册日期
首次提交
2026年4月28日
首先提交符合 QC 标准的
2026年5月21日
首次发布 (实际的)
2026年5月27日
研究记录更新
最后更新发布 (实际的)
2026年6月4日
上次提交的符合 QC 标准的更新
2026年6月3日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Özgül Öztürk
- Grant proposal submitted (其他标识符：Acıbadem University)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data (IPD) will not be shared.
The study data contains personal health information.
Also, data sharing may also be limited by institutional policies and data protection legislation.
Findings will be reported in aggregate form.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.