Muscle and Movement With Anti-Obesity Medications
- Conditions
- Obesity and Overweight
- Registration Number
- NCT06645470
- Lead Sponsor
- University of Kansas Medical Center
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Lean Body Mass 0 and 6 months Lean body mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
- Secondary Outcome Measures
Name Time Method Muscle Mass 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.
Body Fat Mass 0 and 6 months Body fat mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Percent Body Fat 0 and 6 months Percent body fat will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Body Weight 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.
Body Height 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.
Body Mass Index 0 and 6 months; 6, 12, 18 weeks Measurements of weight and height will be used to compute BMI (kg/m2).
Bone Mineral Content o and 6 months Bone mineral content (grams) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Muscular Strength 0 and 6 months Muscular strength will be assessed using grip strength with a hand grip dynamometer.
Physical Function 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.
Cardiorespiratory Fitness 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.
Resting Blood Pressure 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.
Energy Intake (Dietary Intake) 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.
Physical Activity 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.
Health-Related Quality of Life 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.
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States