Exploring the effects of obesity medications combined with exercise on body composition
Muscle Quantity and Quality, With and Without Exercise, Combined With Anti-Obesity Medications
This study is testing if combining obesity medications with different types of exercise can help people lose fat and gain muscle over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT06645470 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to investigate how obesity medications, specifically semaglutide and tirzepatide, affect body composition changes when combined with different types of exercise, such as aerobic and resistance training. Participants will be randomly assigned to receive standard medical care or engage in exercise interventions alongside their medication. The study will measure changes in fat mass, lean mass, muscle mass, bone content, body weight, BMI, and cardiorespiratory fitness over a period of six months. The goal is to determine if exercise enhances the benefits of obesity medications on health and fitness outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with a BMI over 27 and at least one weight-related complication, or a BMI over 30 without complications, who are newly prescribed obesity medications.
Not a fit: Patients who are not newly prescribed obesity medications or those with contraindications to exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing obesity treatment by combining medication with tailored exercise programs.
How similar studies have performed: Other studies have shown promising results in combining obesity medications with exercise, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kansas City, Kansas
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Renee J. Rogers, Ph.D. — University of Kansas Medical Center
- Study coordinator: Renee J. Rogers, Ph.D.
- Email: rrogers10@kumc.edu
- Phone: 913-588-8580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.