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Muscle and Movement With Anti-Obesity Medications

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how obesity medicines change body fat, muscle, and bone over 6 months. It compares usual medical care with supervised heart and lung exercise or strength training to see how they affect these changes and overall health. It is for adults who are about to start semaglutide or tirzepatide for obesity.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Adults ages 18–59 may join the study that assigns treatment groups. Adults older than 60 may join the observation study.
  • People of any sex, race, or ethnic group may join.
  • You must be newly prescribed semaglutide or tirzepatide, have approval to get it, and agree to take it for at least 6 months. You must join before starting it.
  • Your BMI, a measure of weight compared with height, must be above 27 with a weight-related health problem, or above 30 without one.
  • Weight-related problems may include high blood pressure, unhealthy blood fats, blocked breathing during sleep, or heart disease. You must be able to safely complete study tests and exercise.
  • Your weight and size must fit within the limits of the body scan machine.
  • You must be able to understand and agree to take part.
  • The study doctor must approve your participation.

Who can't join

  • You have type 2 diabetes, have had weight-loss surgery, or have lost more than 3% of your weight and kept it off in the past 3 months.
  • Over the past 3 months, you report more than 60 minutes a week of moderate-to-hard exercise AND more than 1 day a week of planned heart and lung exercise or strength training.
  • You are pregnant, were pregnant in the past 6 months, or plan to become pregnant during the study.
  • You have a condition or treatment that affects weight or makes study activities unsafe, or a past muscle disease that could affect your response.
  • You have certain serious heart problems, past heart attack or heart muscle disease, past heart bypass surgery or a procedure to open heart arteries, or a condition needing long-term blood thinners.
  • Your resting blood pressure is above 160 for the top number or 100 for the bottom number. If you take blood pressure medicine, your dose must have been stable for more than 6 months.
  • You have an eating disorder that makes weight loss or exercise unsafe, alcohol or drug abuse, an untreated mental health condition, a mental health hospital stay in the past year, or a mental health medicine dose that has not been stable for at least 6 months.
  • You plan to move too far from the study site, or work, personal, or travel plans would keep you from attending study visits.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

KS