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Changes in Body Composition Including Muscle With Anti-Obesity Medications, Both With and Without Exercise (M3-E)

13 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

198

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • Kansas
      • Kansas City, Kansas, Stany Zjednoczone, 66160
        • Rekrutacyjny
        • University of Kansas Medical Center
        • Kontakt:
        • Główny śledczy:
          • John M. Jakicic, PhD
        • Kontakt:
        • Główny śledczy:
          • Renee J. Rogers, PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Inny: Standard Medical Care with an Obesity Management Medication
Participant will receive standard medical care that includes the prescription and titration of a study eligible obesity management medication.
Behawioralne: Nutrition Counseling
Participant will receive brief nutrition counseling specific to obesity managment medications after randomization for this study.
Eksperymentalny: 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.
Inny: Standard Medical Care with an Obesity Management Medication
Participant will receive standard medical care that includes the prescription and titration of a study eligible obesity management medication.
Behawioralne: Nutrition Counseling
Participant will receive brief nutrition counseling specific to obesity managment medications after randomization for this study.
Behawioralne: Cardiovascular Exercise Training
Participant will receive supervised cardiovascular exercise training on 3 days per week for a period of 6 months.
Eksperymentalny: 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.
Inny: Standard Medical Care with an Obesity Management Medication
Participant will receive standard medical care that includes the prescription and titration of a study eligible obesity management medication.
Behawioralne: Nutrition Counseling
Participant will receive brief nutrition counseling specific to obesity managment medications after randomization for this study.
Behawioralne: Resistance Exercise Training
Participant will receive supervised resistance exercise training on 3 days per week for a period of 6 months.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Lean body mass
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Procent tkanki tłuszczowej
Ramy czasowe: 0 i 6 miesięcy
Procent tkanki tłuszczowej będzie oceniany za pomocą skanu całego ciała wykonanego metodą absorpcjometrii rentgenowskiej o podwójnej energii (DXA).
0 i 6 miesięcy
Masa Tłuszczowa
Ramy czasowe: 0 i 6 miesięcy
Masę tkanki tłuszczowej (kg) ocenia się za pomocą skanu całego ciała wykonanego metodą absorpcjometrii rentgenowskiej o podwójnej energii (DXA).
0 i 6 miesięcy
Muscle Mass
Ramy czasowe: 0 and 6 months
Muscle Mass (kg) will be assessed using the deuterated creatine (D3Cr) dilution method.
0 and 6 months
Muscle Quality
Ramy czasowe: 0 and 6 months
Muscle quality will be assessed using magnetic resonance imaging (MRI) of the mid-thigh.
0 and 6 months
Body Weight
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Bone mineral density
Ramy czasowe: 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
Bone Biomarkers
Ramy czasowe: 0 and 6 months
Bone biomarkers will be assessed from blood samples collected using venipuncture.
0 and 6 months
Waist Circumference
Ramy czasowe: 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
Hip Circumference
Ramy czasowe: 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
Cardiorespiratory Fitness
Ramy czasowe: 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
Ramy czasowe: 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
Cardiorespiratory Fitness
Ramy czasowe: 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
Muscle Strength
Ramy czasowe: 0 and 6 months
Muscular strength will be measured from an isometric leg extension performed on a dynamometer.
0 and 6 months
Physical Function
Ramy czasowe: 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
Muscle Power
Ramy czasowe: 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
Health-Related Quality of Life
Ramy czasowe: 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
Energy Intake (Dietary Intake)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Styl życia i historia zdrowia
Ramy czasowe: 0 miesięcy (przed randomizacją)
Kwestionariusz opracowany specjalnie na potrzeby tego badania i przeprowadzony w formie wywiadu zostanie wykorzystany do oceny stylu życia i czynników zdrowotnych w celu opisania próby do tego badania. Wynik to „tak” lub „nie”, identyfikujący obecność stylu życia lub czynnika zdrowotnego.
0 miesięcy (przed randomizacją)
Medication Reporting
Ramy czasowe: 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
Obesity Management Medication Adherence
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Kansas Medical Center

Współpracownicy

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Śledczy

  • Główny śledczy: John M. Jakicic, PhD, University of Kansas Medical Center
  • Główny śledczy: Renee J. Rogers, PhD, University of Kansas Medical Center

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

31 lipca 2026

Zakończenie podstawowe (Szacowany)

31 marca 2030

Ukończenie studiów (Szacowany)

31 marca 2030

Daty rejestracji na studia

Pierwszy przesłany

30 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 lipca 2026

Pierwszy wysłany (Rzeczywisty)

13 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

15 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

13 lipca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • STUDY00161746
  • R01DK141779-01A1 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

The summary data for each of the study outcomes and other additional demographic characteristics will be made available.

Ramy czasowe udostępniania IPD

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.

Kryteria dostępu do udostępniania IPD

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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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