Changes in Body Composition Including Muscle With Anti-Obesity Medications, Both With and Without Exercise (M3-E)
13 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
198
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: John M. Jakicic, PhD
- Número de teléfono: 913-588-9078
- Correo electrónico: jjakicic@kumc.edu
Copia de seguridad de contactos de estudio
- Nombre: Renee J. Rogers, PhD
- Número de teléfono: 913-588-8580
- Correo electrónico: rrogers10@kumc.edu
Ubicaciones de estudio
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Kansas
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Kansas City, Kansas, Estados Unidos, 66160
- Reclutamiento
- University of Kansas Medical Center
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Contacto:
- John M. Jakicic, PhD
- Número de teléfono: 913-588-9078
- Correo electrónico: jjakicic@kumc.edu
-
Investigador principal:
- John M. Jakicic, PhD
-
Contacto:
- Renee J. Rogers, PhD
- Número de teléfono: 913-588-8580
- Correo electrónico: rrogers10@kumc.edu
-
Investigador principal:
- Renee J. Rogers, PhD
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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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.
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Experimental: 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.
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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.
|
|
Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Lean body mass
Periodo de tiempo: 0 and 6 months
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Porcentaje de grasa corporal
Periodo de tiempo: 0 y 6 meses
|
El porcentaje de grasa corporal se evaluará mediante una exploración corporal total mediante absorciometría de rayos X de energía dual (DXA).
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0 y 6 meses
|
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Masa de grasa corporal
Periodo de tiempo: 0 y 6 meses
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La masa grasa corporal (kg) se evaluará mediante una exploración corporal total mediante absorciometría de rayos X de energía dual (DXA).
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0 y 6 meses
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Muscle Mass
Periodo de tiempo: 0 and 6 months
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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
Periodo de tiempo: 0 and 6 months
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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
Periodo de tiempo: 0 months, week 6, week 12, week 18, 6 months
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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
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Body Mass Index
Periodo de tiempo: 0 months, week 6, week 12, week 18, 6 months
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Measurements of weight and height will be used to compute BMI (kg/m2).
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0 months, week 6, week 12, week 18, 6 months
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Bone mineral content
Periodo de tiempo: 0 and 6 months
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Bone mineral content (grams) 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 mineral density
Periodo de tiempo: 0 and 6 months
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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
Periodo de tiempo: 0 and 6 months
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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
Periodo de tiempo: 0 and 6 months
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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
Periodo de tiempo: 0 and 6 months
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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
Periodo de tiempo: 0 and 6 months
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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
Periodo de tiempo: 0 and 6 months
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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.
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0 and 6 months
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Cardiorespiratory Fitness
Periodo de tiempo: 0 and 6 months
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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
Periodo de tiempo: 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
Periodo de tiempo: 0 and 6 months
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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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 0 months, week 6, week 12, week 18, 6 months
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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
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Energy Intake (Dietary Intake)
Periodo de tiempo: 0 months, week 6, week 12, week 18, 6 months
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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.
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0 months, week 6, week 12, week 18, 6 months
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Physical Activity
Periodo de tiempo: 0 and 6 months
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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.
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0 and 6 months
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Physical Activity
Periodo de tiempo: 0 and 6 months
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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.
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0 and 6 months
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Physical Activity
Periodo de tiempo: 0 and 6 months
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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.
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0 and 6 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Historial de salud y estilo de vida
Periodo de tiempo: 0 meses (antes de la aleatorización)
|
Se utilizará un cuestionario desarrollado específicamente para este estudio que se realiza como una entrevista para evaluar el estilo de vida y los factores de salud para describir la muestra de este estudio.
La puntuación es "sí" o "no", identificando la presencia de un estilo de vida o un factor de salud.
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0 meses (antes de la aleatorización)
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Medication Reporting
Periodo de tiempo: 0 and 6 months, and weeks 3, 6, 9, 12, 15, 18, 21
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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.
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0 and 6 months, and weeks 3, 6, 9, 12, 15, 18, 21
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Obesity Management Medication Adherence
Periodo de tiempo: 0 and 6 months, and weeks 3, 6, 9, 12, 15, 18, 21
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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.
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0 and 6 months, and weeks 3, 6, 9, 12, 15, 18, 21
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Demographic Characteristics
Periodo de tiempo: 0 months
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A questionnaire developed specifically for this study will be used to assessment demographic characteristics (age, sex, race, etc.).
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0 months
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Adverse and Serious Adverse Events
Periodo de tiempo: 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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Participants will be queried using a survey developed specifically for this study will be used to assess for adverse events and serious adverse events.
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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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: John M. Jakicic, PhD, University of Kansas Medical Center
- Investigador principal: Renee J. Rogers, PhD, University of Kansas Medical Center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
31 de julio de 2026
Finalización primaria (Estimado)
31 de marzo de 2030
Finalización del estudio (Estimado)
31 de marzo de 2030
Fechas de registro del estudio
Enviado por primera vez
30 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
6 de julio de 2026
Publicado por primera vez (Actual)
13 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de julio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos Nutricionales
- Sobrenutrición
- Peso corporal
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Exceso de peso
- Obesidad
- Actividad del motor
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Terapéutica
- Modalidades de fisioterapia
- Atención al paciente
- Terapia de ejercicio
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Acondicionamiento físico, humano
- Ejercicio
- Entrenamiento de resistencia
Otros números de identificación del estudio
- STUDY00161746
- R01DK141779-01A1 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
The summary data for each of the study outcomes and other additional demographic characteristics will be made available.
Marco de tiempo para compartir 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.
Criterios de acceso compartido de 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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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