Exploring the effects of obesity medications combined with exercise on body composition

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• IBI3046 in Overweight or Obesity

  This study tests how safe and tolerable IBI3046 is in adults with overweight or obesity in China.

  Recruiting Phase 1 Innovent Biologics (Suzhou) Co. Ltd. · Beijing, Beijing Municipality · NCT07809945

• Sleep behavioral program for adolescents with overweight or obesity

  This trial will test whether adding a sleep-focused behavioral program to usual weight treatment helps teens (13–17) with overweight or obesity who have poor sleep improve body composition and health markers.

  Recruiting University of Beira Interior · Covilha and 1 other locations · NCT07255274

• Robotic versus laparoscopic conversion to RYGB for revision bariatric surgery

  We will see if robotic surgery or laparoscopy leads to fewer postoperative complications for people having revision bariatric surgery converted to RYGB.

  Recruiting GCS Ramsay Santé pour l'Enseignement et la Recherche · Lyon and 1 other locations · NCT07180316

• Bone health, vitamin D, weight, and fractures in children

  See if blood markers (alkaline phosphatase, calcium, PTH, vitamin D), body weight, and calcium intake are linked to fractures in children aged 3–15 after low-energy trauma.

  Recruiting at 2 sites Paracelsus Medical University · Brixen, Bolzano and 1 other locations · NCT07143552

• Efsubaglutide alfa for adults with overweight or obesity (SPARKLE)

  This trial will test whether efsubaglutide alfa injections given weekly or every few weeks help adults with overweight or obesity lose weight safely.

  Recruiting at 5 sites Phase 2 Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. · Brookvale and 4 other locations · NCT07114419

• Cardiovascular health in children and young adults with chronic conditions

  This project will see if children and young adults (ages 6-25) with chronic health conditions show early signs of aging in large and small blood vessels using noninvasive imaging and clinical tests.

  Recruiting Semmelweis University · Budapest and 2 other locations · NCT07086989

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.