Not yet recruitingPhase 3

The Effect of Exercise and Tirzepatide on Weight and Health Outcomes (EXER-MED)

Who can join

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

Age
30 Years to 65 Years
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

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "We will evaluate the impact of the study groups on weight, body composition (percent fat, percent lean mass), blood pressure, arterial stiffness, blood work (cholesterol, blood pressure, glucose, insulin) and quality of life."
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

This is clinical trials is to evaluate the effect of exercise with weight loss medication compared to weight loss alone. The study will enroll 24 adults from 30-65 years old with overweight or obesity. The main questions it will answer includes: * Does exercise combined with weight loss medication reduce body weight and body fat more than weight loss medication alone * Does exercise combined with weight loss medication improve other risk factors more such as the sugar in the blood, cholesterol, fitness, and quality of life Participants will: * Take a weight loss medication (tirzepatide) monthly under the supervision of their primary care physician * (Exercise group only) Will perform exercise \~3 times a week at the University of Virginia). Walking on a treadmill and resistance training * Visit the study site at the beginning of the study and after the study to evaluate weight, body fat, and other health measures

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

Eligibility

Official eligibility criteria

Inclusion Criteria: * Men and women 30-65 years of age, postmenopausal women included * 27-29.9 with an additional CVD risk factor or 30-40 kg/m2 * For overweight adults only: additional cardiometabolic risk factor (diagnosed dyslipidemia, hypertension) * Willingness and adequate health to go on weight loss medication * The capability and willingness to provide written informed consent * Approval of their primary care provider to go on weight loss medication Exclusion Criteria: * Including but not limited to serious arrhythmias * Cardiomyopathy * Congestive heart failure * Stroke or transient ischemic attacks * Peripheral vascular disease * Previous history of myocardial infarction or stroke * Previous diagnosis or taking medication for type 1 or 2 diabetes, fasting glucose \>125 mg/dL or HbA1C ≥6.5% * Systolic blood pressure \>160 mmHg and diastolic blood pressure \>100 mmHg. * Hospitalization for mental illness within the past 5 years or currently undergoing treatment for severe mental illness * Conditions that can be aggravated or are contraindicated by exercise training * Plans to be out of town more than 3 weeks in the next 4 months. * Currently pregnant or plans to become pregnant * Currently in a diet or exercise program * Non-compliance during screening or extreme difficulty in obtaining baseline blood samples * Enrolled in a different exercise program * Previous weight loss surgery * Use of weight loss medication within the last year * hypo/hyper thyroid (medicated or unmedicated)

Study sites (1)

VA

  • University of Virginia · Charlottesville, VA 22901Damon L Swift, Ph.D. · Study contact · (434) 924-1436Damon L Swift, Ph.D. · Principal investigatorCatherine Varney, DO · Sub-investigatorJay Hertel, Ph.D. · Sub-investigatorMore trials in Charlottesville