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.
調査の概要
状態
募集
条件
研究の種類
介入
入学 (推定)
198
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：John M. Jakicic, PhD
- 電話番号：913-588-9078
- メール：jjakicic@kumc.edu
研究連絡先のバックアップ
- 名前：Renee J. Rogers, PhD
- 電話番号：913-588-8580
- メール：rrogers10@kumc.edu
研究場所
-
-
Kansas
-
Kansas City、Kansas、アメリカ、66160
- 募集
- University of Kansas Medical Center
-
コンタクト：
- John M. Jakicic, PhD
- 電話番号：913-588-9078
- メール：jjakicic@kumc.edu
-
主任研究者：
- John M. Jakicic, PhD
-
コンタクト：
- Renee J. Rogers, PhD
- 電話番号：913-588-8580
- メール：rrogers10@kumc.edu
-
主任研究者：
- Renee J. Rogers, PhD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Lean body mass
時間枠：0 and 6 months
|
Lean Body Mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
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0 and 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
体脂肪率
時間枠：0ヶ月と6ヶ月
|
体脂肪率は、二重エネルギー X 線吸光光度計 (DXA) による全身スキャンを使用して評価されます。
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0ヶ月と6ヶ月
|
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体脂肪量
時間枠：0ヶ月と6ヶ月
|
体脂肪量 (kg) は、二重エネルギー X 線吸光光度計 (DXA) による全身スキャンを使用して評価されます。
|
0ヶ月と6ヶ月
|
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Muscle Mass
時間枠：0 and 6 months
|
Muscle Mass (kg) will be assessed using the deuterated creatine (D3Cr) dilution method.
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0 and 6 months
|
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Muscle Quality
時間枠：0 and 6 months
|
Muscle quality will be assessed using magnetic resonance imaging (MRI) of the mid-thigh.
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0 and 6 months
|
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Body Weight
時間枠：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.
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0 months, week 6, week 12, week 18, 6 months
|
|
Body Mass Index
時間枠：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
時間枠：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
時間枠：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).
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0 and 6 months
|
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Bone Biomarkers
時間枠：0 and 6 months
|
Bone biomarkers will be assessed from blood samples collected using venipuncture.
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0 and 6 months
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Waist Circumference
時間枠：0 and 6 months
|
Circumference measures of the waist will be taken horizontally at both the iliac crest and the umbilicus.
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0 and 6 months
|
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Hip Circumference
時間枠：0 and 6 months
|
Circumference measures of the hip will be taken horizontally at the widest observed portion of the buttocks.
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0 and 6 months
|
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Cardiorespiratory Fitness
時間枠：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.
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0 and 6 months
|
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Cardiorespiratory Fitness
時間枠：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
時間枠：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.
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0 and 6 months
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Muscle Strength
時間枠：0 and 6 months
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Muscular strength will be measured from an isometric leg extension performed on a dynamometer.
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0 and 6 months
|
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Physical Function
時間枠：0 and 6 months
|
Physical function will be measured using the Short Physical Performance Protocol (SPPB) that includes balance, gait speed, and chair stands).
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0 and 6 months
|
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Muscle Power
時間枠：0 and 6 months
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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.
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0 and 6 months
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Health-Related Quality of Life
時間枠：0 and 6 months
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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.
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0 and 6 months
|
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Energy Intake (Dietary Intake)
時間枠：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.
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0 months, week 6, week 12, week 18, 6 months
|
|
Energy Intake (Dietary Intake)
時間枠：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
時間枠：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
|
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Physical Activity
時間枠：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
|
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Physical Activity
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ライフスタイルと健康歴
時間枠：0 か月 (ランダム化前)
|
この研究のために特別に開発されたアンケートは、インタビューとして実施され、この研究のサンプルを説明するためにライフスタイルと健康要因を評価するために使用されます。
スコアは「はい」または「いいえ」のいずれかで、ライフスタイルまたは健康要因の存在を特定します。
|
0 か月 (ランダム化前)
|
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Medication Reporting
時間枠：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
時間枠：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
|
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Demographic Characteristics
時間枠：0 months
|
A questionnaire developed specifically for this study will be used to assessment demographic characteristics (age, sex, race, etc.).
|
0 months
|
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Adverse and Serious Adverse Events
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：John M. Jakicic, PhD、University of Kansas Medical Center
- 主任研究者：Renee J. Rogers, PhD、University of Kansas Medical Center
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月31日
一次修了 (推定)
2030年3月31日
研究の完了 (推定)
2030年3月31日
試験登録日
最初に提出
2026年6月30日
QC基準を満たした最初の提出物
2026年7月6日
最初の投稿 (実際)
2026年7月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月15日
QC基準を満たした最後の更新が送信されました
2026年7月13日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00161746
- R01DK141779-01A1 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
The summary data for each of the study outcomes and other additional demographic characteristics will be made available.
IPD 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。