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NCT Number: NCT06645470

Muscle and Movement With Anti-Obesity Medications

The goal of this clinical trial is to learn about changes in body composition related to obesity medication use, and whether aerobic or resistance exercise training will impact these body composition changes. It will also provide information about whether aerobic or resistance exercise training 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 body composition (fat mass, lean mass, muscle mass, and bone content) between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in body weight and BMI between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in cardiorespiratory fitness between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in how much physical activity is completed between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in physical function between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in muscle strength between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in resting blood pressure between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in food intake between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in health-related quality of life between the standard medical care and the exercise conditions (aerobic training and resistance training)?

Participants will:

* Participate in an intervention for a period of 6 months that involves being assigned to a no exercise/standard medical care condition, or a supervised exercise condition (aerobic training or resistance training). * Visit the clinical before starting the study and at 6 months to complete study measurements of their body composition and other measurements to monitor their progress. * Complete a brief monitoring session at weeks 6, 12, and 18 across the 6 months. * Complete supervised exercise sessions at the research center 3x per week for 6 months (Participants in the exercise groups only: aerobic training or resistance training).

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Key information

Conditions

Obesity and Overweight Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both males and females of all race/ethnic groups are eligible for participation in this study.
  • Age: Randomized Study: Adults that are 18 to <60 years of age. Observational Study: Adults that are >60 years of age.
  • Newly prescribed AOM (semaglutide, tirzepatide) for the treatment of obesity, 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 this 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. Enrollment will not be limited based on an upper BMI level provided that the participant meets the other eligibility requirements. However, weight or size limits of the dual-energy x-ray absorptiometry (DXA) system that is used to assess body composition must not be exceeded.
  • 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 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, pregnant within the past 6 months, 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.).
  • 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.

Treatment and study plan

Standard Medical Care (SMC)

Other

Standard Medical Care will continue to receive their regular standard clinical care during the 6-month intervention period of this study.

Monitoring Contacts

Behavioral

Participants will receive contacts with the research staff at weeks 6, 12, and 18.

Aerobic training

Behavioral

Aerobic Training will be supervised exercise. It 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, alternative forms of cardiovascular exercise (upright cycling, elliptical, etc.) are allowed to accommodate any physical limitations that may be present for a participant. Heart rate will be monitored throughout these exercise sessions.

Resistance training

Behavioral

Resistance Training will be supervised exercise. It will occur 3 days per week and includes 8 exercises performed in a prespecified order. Week 1-2 sessions focus on familiarization to acclimate the participant to the equipment, proper form, to establish initial weight (load) for training, and with performing multiple sets per day. For Weeks 3-8, participants will engage in 2 sets per exercise with the weight adjusted to elicit muscle fatigue in 8-12 repetitions per set. This progresses to 3 sets per exercise from Week 9 until the end of the intervention period. When 12 repetitions for a specific exercise can be achieved, the resistance will increase for that exercise at the next session. There is a 90 second rest period between each set of an exercise. Heart rate will be monitored throughout these exercise sessions.

Nutrition education

Other

A single counseling session to discuss the dietary recommendations when taking an obesity medication.

Primary outcomes

  1. Lean Body Mass

    Time frame: 0 and 6 months

    Lean body mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).

Secondary outcomes

  1. Body Fat Mass

    Time frame: 0 and 6 months

    Body fat mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).

  2. Percent Body Fat

    Time frame: 0 and 6 months

    Percent body fat will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).

  3. Body Weight

    Time frame: 0 and 6 months; 6, 12, 18 weeks

    Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg.

  4. Body Height

    Time frame: 0 and 6 months; 6, 12, and 18 weeks

    Body height will be assessed in duplicate using a wall mounted stadiometer to the nearest 0.1 cm.

  5. Body Mass Index

    Time frame: 0 and 6 months; 6, 12, 18 weeks

    Measurements of weight and height will be used to compute BMI (kg/m2).

  6. Bone Mineral Content

    Time frame: o and 6 months

    Bone mineral content (grams) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).

  7. Muscle Mass

    Time frame: 0 and 6 months

    Muscle mass will be assessed using the deuterated creatine (D3Cr) dilution method. A 30mg capsule of D3Cr is ingested and 48-72 hrs later, a fasting urine sample is provided for analysis.

  8. Muscular Strength

    Time frame: 0 and 6 months

    Muscular strength will be assessed using isometric leg extension on a Biodex.

  9. Muscular Strength

    Time frame: 0 and 6 months

    Muscular strength will be assessed using grip strength with a hand grip dynamometer.

  10. Physical Function

    Time frame: 0 and 6 months

    Physical Function will be assessed using the Short Physical Performance Battery (SPPB) that includes balance, gait speed, and chair stands. A composite score with a range from 0 to 12 (no units) of these measures is used. A higher score represents better physical functioning.

  11. Cardiorespiratory Fitness

    Time frame: 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.

  12. Cardiorespiratory Fitness

    Time frame: 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.

  13. Cardiorespiratory Fitness

    Time frame: 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.

  14. Resting Blood Pressure

    Time frame: 0 and 6 months; 6, 12, and 18 weeks

    Resting seated blood pressure, both systolic and diastolic (mmHg), will be assessed using an automated system.

  15. Energy Intake (Dietary Intake)

    Time frame: 0 and 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.

  16. Physical Activity

    Time frame: 0 and 6 months

    Physical activity is measured by the Global Physical Activity Questionnaire (GPAQ). This assesses time spent in recreational, occupational, household, and transportation physical activities and is represented as minutes per week. Higher minutes per week indicate greater physical activity participation. The range is 0 to 10,080 minutes per week.

  17. Health-Related Quality of Life

    Time frame: 0 and 6 months

    Health-Related Quality of Life will be measured with a 36-item questionnaire (RAND 36-Item Health Survey) that includes 8 subscales of vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health or emotional wellbeing. All items are scored so that a high score defines a more favorable health state. The range of the final score for each subscale is 0-100.

Other outcomes

  1. Demographic Characteristics

    Time frame: 0 months

    Demographic Characteristics will be assessed using a survey.

  2. Lifestyle and Health History

    Time frame: 0 months

    A questionnaire developed specifically for this study that is conducted as an interview will be used to assess lifestyle and health factors to describe the sample for this study. The score is either "yes" or "no" identifying the presences of a lifestyle or health factor.

  3. Medication History

    Time frame: 0 and 6 months; 6, 12, and 18 weeks

    A questionnaire developed specifically for this study will be used to assessment medication history. 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.

  4. Adverse and Serious Adverse Events

    Time frame: 0 and 6 months; 6, 12, and 18 weeks

    Participants will be queried using a survey developed specifically for this study will be used to assess for adverse events and serious adverse events.

Study contacts

Contact information is provided by the study sponsor or research team.

John M. Jakicic, Ph.D.

CONTACT

[email protected]

913-588-9078

Renee J. Rogers, Ph.D.

CONTACT

[email protected]

913-588-8580

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

Muscle Quantity and Quality, With and Without Exercise, Combined With Anti-Obesity Medications

Acronym: M3

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2024
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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