Changes in Body Composition Including Muscle With Anti-Obesity Medications, Both With and Without Exercise

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorUniversity of Kansas Medical Center

About this trial

The goal of this clinical trial is to learn whether adding either cardiovascular exercise or resistance exercise to pharmacotherapy treatment for obesity improves the retention of lean mass compared to pharmacotherapy alone in adults with overweight or obesity who are prescribed pharmacotherapy for obesity treatment by their personal physician. It will also provide information about whether either form of exercise added to pharmacotherapy for obesity treatment 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 total lean body mass between pharmacotherapy alone and either pharmacotherapy plus cardiovascular exercise or pharmacotherapy plus resistance exercise? * Is there a difference in the change in muscle mass between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in muscle quality between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in body weight between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in body composition (fat mass, fat mass distribution) between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in cardiorespiratory fitness between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in muscle strength between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in physical function between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in bone mineral density between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in bone biomarkers between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in resting blood pressure between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in energy intake between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in physical activity between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there an effect of sex, race/ethnicity, age, menopausal status, obesity management medication type, or other demographic characteristics on the outcomes that are being measured. * What is the extent to which the retention of lean body mass or muscle mass mediates the effect of exercise on weight changes.

Participants will:

* Initiate and continue throughout the study period an eligible obesity management medication that is prescribed by their healthcare provider, and to report their adherence to this medication to the investigators. * Participant in this study for a period of 6-8 months to complete outcome assessments that occur at baseline and at the conclusion of 6 months of the intervention period, and monitoring visits that occur at weeks 3, 6, 9, 12, 15, 18, and 21. * If attend 3 supervised exercise sessions per week if assigned to either the cardiovascular exercise intervention or the resistance training intervention for a period of 24 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Both males and females of all race/ethnic groups are eligible for participation in this study.

18 to <65 years of age.

Newly prescribed FDA-approved obesity manage medication that can include Tirzepatide, Semaglutide, or up to 4 additional next-generation obesity management medications (will receive DSMB approval prior to inclusion), 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 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. We will not limit enrollment based on an upper BMI level provided that the participant meets the other eligibility requirements. However, the participant will be excluded if they exceed the weight or size limits of the dual-energy x-ray absorptiometry (DXA) system that is used to assess body composition or the MRI that is used to assess muscle quality.

Disqualifiers

Type 2 diabetes.

Report moderate-to-vigorous exercise for >60 min/week, and >1 day/week 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Medical Care with an Obesity Management Medication

    Other intervention

    Participant will receive standard medical care that includes the prescription and titration of a study eligible obesity management medication.

  • Cardiovascular Exercise Training

    Behavioral

    Participant will receive supervised cardiovascular exercise training on 3 days per week for a period of 6 months.

  • Resistance Exercise Training

    Behavioral

    Participant will receive supervised resistance exercise training on 3 days per week for a period of 6 months.

  • Nutrition Counseling

    Behavioral

    Participant will receive brief nutrition counseling specific to obesity managment medications after randomization for this study.

Treatment groups

198 Participants
are divided into 3 treatment groups
Group A: Standard Care with an Obesity Management MedicationExperimental treatment 2 interventions
Group B: Standard Care with an Obesity Management Medication Plus Cardiovascular Exercise TrainingExperimental treatment 3 interventions
Group C: Standard Care with an Obesity Management Medication Plus Resistance Exercise TrainingExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Lean body mass

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

Time frame
0 and 6 months

Secondary outcomes

1

Muscle Mass

Muscle Mass (kg) will be assessed using the deuterated creatine (D3Cr) dilution method.

Time frame
0 and 6 months
2

Muscle Quality

Muscle quality will be assessed using magnetic resonance imaging (MRI) of the mid-thigh.

Time frame
0 and 6 months
3

Body Weight

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

Time frame
0 months, week 6, week 12, week 18, 6 months
4

Body Mass Index

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

Time frame
0 months, week 6, week 12, week 18, 6 months

Other outcomes

1

Medication Reporting

A questionnaire developed specifically for this study will be used to assess medication history and use of prescribed obesity management medications. 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.

Time frame
0 and 6 months, and weeks 3, 6, 9, 12, 15, 18, 21
2

Obesity Management Medication Adherence

A questionnaire developed specifically for this study will be used to assess adherence to the prescribed obesity management medications. The data collected include the type of medication, dose of medication, and frequency that the medication is taken.

Time frame
0 and 6 months, and weeks 3, 6, 9, 12, 15, 18, 21
3

Demographic Characteristics

A questionnaire developed specifically for this study will be used to assessment demographic characteristics (age, sex, race, etc.).

Time frame
0 months
4

Lifestyle and Health History

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.

Time frame
0 months (prior to randomization)

Sponsors and contacts

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University of Kansas Medical Center

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator