Changes in Body Composition Including Muscle With Anti-Obesity Medications, Both With and Without Exercise (M3-E)
2026年7月13日 更新者：John M. Jakicic, PhD、University of Kansas Medical Center
The goal of this clinical trial is to learn whether adding either cardiovascular exercise or resistance exercise to pharmacotherapy treatment for obesity improves the retention of lean mass compared to pharmacotherapy alone in adults with overweight or obesity who are prescribed pharmacotherapy for obesity treatment by their personal physician. It will also provide information about whether either form of exercise added to pharmacotherapy for obesity treatment has additional benefits on other health and fitness measurements. The main questions it aims to answer are:
- Is there a difference in the change in total lean body mass between pharmacotherapy alone and either pharmacotherapy plus cardiovascular exercise or pharmacotherapy plus resistance exercise?
- Is there a difference in the change in muscle mass between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in muscle quality between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in body weight between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in body composition (fat mass, fat mass distribution) between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in cardiorespiratory fitness between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in muscle strength between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in physical function between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in bone mineral density between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in bone biomarkers between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in resting blood pressure between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in energy intake between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in physical activity between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there an effect of sex, race/ethnicity, age, menopausal status, obesity management medication type, or other demographic characteristics on the outcomes that are being measured.
- What is the extent to which the retention of lean body mass or muscle mass mediates the effect of exercise on weight changes.
Participants will:
- Initiate and continue throughout the study period an eligible obesity management medication that is prescribed by their healthcare provider, and to report their adherence to this medication to the investigators.
- Participant in this study for a period of 6-8 months to complete outcome assessments that occur at baseline and at the conclusion of 6 months of the intervention period, and monitoring visits that occur at weeks 3, 6, 9, 12, 15, 18, and 21.
- If attend 3 supervised exercise sessions per week if assigned to either the cardiovascular exercise intervention or the resistance training intervention for a period of 24 weeks.
研究概览
地位
招聘中
条件
研究类型
介入性
注册 (估计的)
198
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：John M. Jakicic, PhD
- 电话号码：913-588-9078
- 邮箱：jjakicic@kumc.edu
研究联系人备份
- 姓名：Renee J. Rogers, PhD
- 电话号码：913-588-8580
- 邮箱：rrogers10@kumc.edu
学习地点
-
-
Kansas
-
Kansas City、Kansas、美国、66160
- 招聘中
- University of Kansas Medical Center
-
接触：
- John M. Jakicic, PhD
- 电话号码：913-588-9078
- 邮箱：jjakicic@kumc.edu
-
首席研究员：
- John M. Jakicic, PhD
-
接触：
- Renee J. Rogers, PhD
- 电话号码：913-588-8580
- 邮箱：rrogers10@kumc.edu
-
首席研究员：
- Renee J. Rogers, PhD
-
-
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
接受健康志愿者
不
描述
Inclusion Criteria:
- Both males and females of all race/ethnic groups are eligible for participation in this study.
- 18 to <65 years of age.
- Newly prescribed FDA-approved obesity manage medication that can include Tirzepatide, Semaglutide, or up to 4 additional next-generation obesity management medications (will receive DSMB approval prior to inclusion), approval for treatment (pharmacy, insurance, etc.), and the participant agreeing to start this treatment and continue treatment for at least 6 months (the participant will be recruited prior to this medication being initiated).
- Body mass index (BMI) of >=27.0 kg/m2 with at least one weight-related complication (hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease) provided it does not compromise the ability to safely complete the screening or outcome measures or to engage in the prescribed exercise interventions), or >=30 kg/m2 without weight-related complications. We will not limit enrollment based on an upper BMI level provided that the participant meets the other eligibility requirements. However, the participant will be excluded if they exceed the weight or size limits of the dual-energy x-ray absorptiometry (DXA) system that is used to assess body composition or the MRI that is used to assess muscle quality.
- Ability to provide informed consent prior to participation in this study.
- Clearance from the study physician for meeting all eligibility criteria for this study.
Exclusion Criteria:
- Type 2 diabetes.
- Report moderate-to-vigorous exercise for >60 min/week, and >1 day/week of structured cardiovascular or resistance exercise over the past 3 months.
- Report sustained weight loss of >=3% in the past 3 months.
- History of metabolic/bariatric surgery.
- Females who are pregnant or breastfeeding or reporting a planned pregnancy during the study period.
- Report a current medical condition or treatment for a medical condition that could affect body weight or contradict engagement in any aspect of the outcome measures or interventions.
- History of muscle conditions that may impact the quality of muscle or response to the study interventions (e.g., myopathy, muscular dystrophy, rhabdomyolysis, etc.).
- Contraindications to MRI (e.g., metal implants that are not MRI safe, etc.). NOTE: Participants who are otherwise eligible other than being contraindicated for the MRI scan will be eligible and the MRI scan will not be performed as a research procedure.
- Current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of an increased acute risk for a cardiovascular event, prior myocardial infarction or history of cardiomyopathy, coronary artery bypass grafting or angioplasty, conditions requiring chronic anticoagulation (i.e., recent or recurrent DVT).
- Resting systolic blood pressure of >=160 mmHg or resting diastolic blood pressure of >=100 mmHg. If medicated for blood pressure control, the medication dose needs to be stable for >=6 months.
- Eating disorders that would contraindicate weight loss or physical activity.
- Alcohol or substance abuse.
- Current psychological condition that is untreated, hospitalization for a psychological condition within the past 12 months, or not being on a stable dose of treatment for at least 6 months.
- Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance at scheduled intervention sessions or assessments.
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：Standard Care with an Obesity Management Medication
Participants will receive standard medical care from their personal physician related to their obesity management medication for a period of 6 months.
Progression of this medication will be monitored as part of the participation in this study.
Participants will undergo screening and baseline assessments prior to initiating the use of the medication and after a period of 6 months.
Upon randomization, participants will receive a "Nutrition 101" session where dietary considerations while taking this medication will be discussed.
We will also have a brief contact (weeks 3, 6, 9, 12, 15, 18, and 21) with the participant to monitor changes in weight, blood pressure, health status, and medication adherence and use (including the dose of the obesity management medication that they have been prescribed).
Participants will be instructed to maintain their current level of physical activity throughout the 6-month study period.
|
Participant will receive standard medical care that includes the prescription and titration of a study eligible obesity management medication.
Participant will receive brief nutrition counseling specific to obesity managment medications after randomization for this study.
|
|
实验性的：Standard Care with an Obesity Management Medication Plus Cardiovascular Exercise Training
Participants will receive the same standard of care as described for the "Standard Care with an Obesity Management Medication" condition; however, participants will also engage in supervised cardiovascular exercise training.
This will occur on 3 days per week and will progress to 50 minutes per session (150 minutes per week).
The intensity of the exercise will progress from 60%±5% to 70%±5% of age-predicted maximal heart rate (if taking beta-blocker medication intensity will progress from a Rating of Perceived Exertion of 11-13 to 12-14 based on the 6-20 Borg scale).
While walking will be the preferred mode of exercise, we will allow for alternative forms of cardiovascular exercise (upright or recumbent cycling, elliptical, etc.) to accommodate any physical limitations that may be present for a participant.
Heart rate will be monitored throughout these exercise sessions.
|
Participant will receive standard medical care that includes the prescription and titration of a study eligible obesity management medication.
Participant will receive brief nutrition counseling specific to obesity managment medications after randomization for this study.
Participant will receive supervised cardiovascular exercise training on 3 days per week for a period of 6 months.
|
|
实验性的：Standard Care with an Obesity Management Medication Plus Resistance Exercise Training
Participants will receive the same standard of care as described for the "Standard Care with an Obesity Management Medication" condition; however, participants will also engage in supervised resistance exercise training.
This will occur 3 days per week and involve 9 different exercises.
Each exercise will progress to 3 sets with a rest period of 60 to 90 seconds between each set.
Warm-up sets will include 10 repetitions, and all remaining sets will perform repetitions until volitional fatigue.
Heart rate will be monitored throughout these exercise sessions.
|
Participant will receive standard medical care that includes the prescription and titration of a study eligible obesity management medication.
Participant will receive brief nutrition counseling specific to obesity managment medications after randomization for this study.
Participant will receive supervised resistance exercise training on 3 days per week for a period of 6 months.
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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 |
|---|---|---|
|
Lean body mass
大体时间：0 and 6 months
|
Lean Body Mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
|
0 and 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
身体脂肪百分比
大体时间：0 和 6 个月
|
将使用双能 X 射线吸收测定法 (DXA) 进行全身扫描来评估身体脂肪百分比。
|
0 和 6 个月
|
|
身体脂肪量
大体时间：0 和 6 个月
|
将使用双能 X 射线吸收测定法 (DXA) 进行全身扫描来评估身体脂肪量 (kg)。
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0 和 6 个月
|
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Muscle Mass
大体时间：0 and 6 months
|
Muscle Mass (kg) will be assessed using the deuterated creatine (D3Cr) dilution method.
|
0 and 6 months
|
|
Muscle Quality
大体时间：0 and 6 months
|
Muscle quality will be assessed using magnetic resonance imaging (MRI) of the mid-thigh.
|
0 and 6 months
|
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Body Weight
大体时间：0 months, week 6, week 12, week 18, 6 months
|
Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg.
|
0 months, week 6, week 12, week 18, 6 months
|
|
Body Mass Index
大体时间：0 months, week 6, week 12, week 18, 6 months
|
Measurements of weight and height will be used to compute BMI (kg/m2).
|
0 months, week 6, week 12, week 18, 6 months
|
|
Bone mineral content
大体时间：0 and 6 months
|
Bone mineral content (grams) will be assessed using total body, femur, and spine scans from dual-energy x-ray absorptiometry (DXA).
|
0 and 6 months
|
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Bone mineral density
大体时间：0 and 6 months
|
Bone mineral density (g/cm2) will be assessed using total body, femur, and spine scans from dual-energy x-ray absorptiometry (DXA).
|
0 and 6 months
|
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Bone Biomarkers
大体时间：0 and 6 months
|
Bone biomarkers will be assessed from blood samples collected using venipuncture.
|
0 and 6 months
|
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Waist Circumference
大体时间：0 and 6 months
|
Circumference measures of the waist will be taken horizontally at both the iliac crest and the umbilicus.
|
0 and 6 months
|
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Hip Circumference
大体时间：0 and 6 months
|
Circumference measures of the hip will be taken horizontally at the widest observed portion of the buttocks.
|
0 and 6 months
|
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Cardiorespiratory Fitness
大体时间：0 and 6 months
|
Cardiorespiratory fitness will be represented as milliliters of oxygen consumed per kilogram of body weight per minute (ml/kg/min) measured with a metabolic cart during a submaximal graded exercise test that is terminated when the participant achieves 85% of age-predicted maximal heart rate or if taking a medication that will impact heart rate response to exercise, then achieving a Rating of Perceived Exertion (RPE) of 16 on the 6-20 scale.
|
0 and 6 months
|
|
Cardiorespiratory Fitness
大体时间：0 and 6 months
|
Cardiorespiratory fitness will be represented as total liters of oxygen consumed per minute (L/min) measured with a metabolic cart during a submaximal graded exercise test that is terminated when the participant achieves 85% of age-predicted maximal heart rate or if taking a medication that will impact heart rate response to exercise, then achieving a Rating of Perceived Exertion (RPE) of 16 on the 6-20 scale.
|
0 and 6 months
|
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Cardiorespiratory Fitness
大体时间：0 and 6 months
|
Cardiorespiratory fitness will be the duration measured in minutes to achieve 85% of age-predicted maximal heart rate during a submaximal graded exercise test performed on a treadmill or if taking a medication that will impact heart rate response to exercise, then achieving a Rating of Perceived Exertion (RPE) of 16 on the 6-20 scale.
|
0 and 6 months
|
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Muscle Strength
大体时间：0 and 6 months
|
Muscular strength will be measured from an isometric leg extension performed on a dynamometer.
|
0 and 6 months
|
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Physical Function
大体时间：0 and 6 months
|
Physical function will be measured using the Short Physical Performance Protocol (SPPB) that includes balance, gait speed, and chair stands).
|
0 and 6 months
|
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Muscle Power
大体时间：0 and 6 months
|
Muscle Power is measured using the Margaria Power Stair Climb Task that requires the participant to walk up a standardized flight of stair, with the score being the time it takes to walk from the 3rd step to the 9th step.
A faster time at a given body mass indicates a greater level of muscle power.
|
0 and 6 months
|
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Health-Related Quality of Life
大体时间：0 and 6 months
|
Health-related quality of life is assessed with a standardized questionnaire.
This questionnaire consists of 8 scales (physical functioning, role limitations caused by health problems, role limitation caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, general health perceptions) with each scale score between 0-100.
This also consists of 2 subscales (physical and mental health) with these being scored as the average of the scores from the scales that are factored into each measure.
This also provides an overall score, which is the average of the scores for each of the 8 scales.
A higher score on a scale or subscale indicates a higher health-related quality of life.
|
0 and 6 months
|
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Energy Intake (Dietary Intake)
大体时间：0 months, week 6, week 12, week 18, 6 months
|
Energy Intake (Dietary Intake) expressed as kilocalories eaten per day (kcal/day) will be measured using the Diet History Questionnaire (DHQ) developed by NCI.
A higher score represents more calories eaten.
|
0 months, week 6, week 12, week 18, 6 months
|
|
Energy Intake (Dietary Intake)
大体时间：0 months, week 6, week 12, week 18, 6 months
|
Energy Intake (Dietary Intake) expressed as kilocalories eaten per day (kcal/day) will be measured using a 3-day dietary recall (2 weekdays and 1 weekend day).
A higher score represents more calories eaten.
|
0 months, week 6, week 12, week 18, 6 months
|
|
Physical Activity
大体时间：0 and 6 months
|
Physical activity will be measured using the Physical Activity and Exercise Questionnaire.
A higher score represents more physical activity expressed as minutes per week or calories of energy expenditure per week.
|
0 and 6 months
|
|
Physical Activity
大体时间：0 and 6 months
|
Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ).
A higher score represents more physical activity expressed as minutes per week or calories of energy expenditure per week.
|
0 and 6 months
|
|
Physical Activity
大体时间：0 and 6 months
|
Physical activity will be measured Garmin wrist worn activity tracker that will be provided to each participant to wear throughout the entire 6 month intervention period.
A higher score represents more physical activity.
|
0 and 6 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
生活方式和健康史
大体时间：0 个月（随机化前）
|
专门为本研究开发的调查问卷以访谈形式进行，将用于评估生活方式和健康因素，以描述本研究的样本。
分数为“是”或“否”，表明生活方式或健康因素是否存在。
|
0 个月（随机化前）
|
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Medication Reporting
大体时间：0 and 6 months, and weeks 3, 6, 9, 12, 15, 18, 21
|
A questionnaire developed specifically for this study will be used to assess medication history and use of prescribed obesity management medications.
The data collected include the type of medication, dose of medication, and frequency that the medication is taken, and what condition the medication is indicated to treat.
|
0 and 6 months, and weeks 3, 6, 9, 12, 15, 18, 21
|
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Obesity Management Medication Adherence
大体时间：0 and 6 months, and weeks 3, 6, 9, 12, 15, 18, 21
|
A questionnaire developed specifically for this study will be used to assess adherence to the prescribed obesity management medications.
The data collected include the type of medication, dose of medication, and frequency that the medication is taken.
|
0 and 6 months, and weeks 3, 6, 9, 12, 15, 18, 21
|
|
Demographic Characteristics
大体时间：0 months
|
A questionnaire developed specifically for this study will be used to assessment demographic characteristics (age, sex, race, etc.).
|
0 months
|
|
Adverse and Serious Adverse Events
大体时间：0 and 6 months, and weeks 3, 6, 9, 12, 15, 18, 21 and at other times when reported by the participant
|
Participants will be queried using a survey developed specifically for this study will be used to assess for adverse events and serious adverse events.
|
0 and 6 months, and weeks 3, 6, 9, 12, 15, 18, 21 and at other times when reported by the participant
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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。
调查人员
- 首席研究员：John M. Jakicic, PhD、University of Kansas Medical Center
- 首席研究员：Renee J. Rogers, PhD、University of Kansas Medical Center
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7月31日
初级完成 (估计的)
2030年3月31日
研究完成 (估计的)
2030年3月31日
研究注册日期
首次提交
2026年6月30日
首先提交符合 QC 标准的
2026年7月6日
首次发布 (实际的)
2026年7月13日
研究记录更新
最后更新发布 (实际的)
2026年7月15日
上次提交的符合 QC 标准的更新
2026年7月13日
最后验证
2026年6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
- STUDY00161746
- R01DK141779-01A1 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The summary data for each of the study outcomes and other additional demographic characteristics will be made available.
IPD 共享时间框架
The data will be made available no later than the time of an associated publication of study outcomes or at the end of the performance period, whichever comes first.
The data provided to the repository will be available indefinitely while that repository continues to exist.
IPD 共享访问标准
The information included with the IPD will be made available to appropriate individuals only after the requester confirms their willingness to comply with an appropriate "Data Use Agreement" that complies with NIH policies, the policies of the institution where the study has been conducted, and the elements of informed consent.
IPD 共享支持信息类型
- 研究方案
- 树液
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
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.