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Not yet recruiting NCT07298915

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

Phase III Interventional Obesity & Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tirzepatide, Exercise.
Who it may be relevant to
Registry conditions: Obesity & Overweight. Basic parameters: 30 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

Detailed description

The new type class of weight loss medications called GLP-1 medications have been shown to cause weight loss and improve risk factors for heart disease and diabetes. One thing that is currently unknown is whether exercise augments the impact of weight loss in people taking GLP-1 medication. The EXER-MED study is a pilot study evaluating the effect of 16 weeks of exercise training with GLP-1 medication compared to taking the medication alone. 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.

Interventions

  • Drug Tirzepatide
    Participants will take tirzepatide under the care of their primary care provider for 16 weeks
  • Behavioral Exercise
    Participants will perform a combination of aerobic and resistance training for 16 weeks

Primary outcome measures

  • Weight [Time frame: Baseline and 16 Weeks]
Secondary outcome measures (12)
  • Physical activity level [Time frame: Baseline and 16 weeks]
  • Changes in Blood Lipids Concentrations [Time frame: Baseline to 16 weeks]
  • Resting Metabolic Rate [Time frame: Baseline and 16 Weeks]
  • Change in Fasting Glucose Level [Time frame: Baseline to 16 Weeks]
  • Change in Fasting Insulin Level [Time frame: Baseline to 16 Weeks]
  • Change in Augmentation Index [Time frame: Baseline to 16 Weeks]
  • Changes in Blood Pressure (mmHg) [Time frame: Baseline to 16 weeks]
  • Change in hemoglobin A1C [Time frame: Baseline and Week 16]
  • Change in Waist Circumference [Time frame: Baseline to Week 16]
  • Change in Body Composition (Fat mass or Lean Mass) [Time frame: Baseline to Week 16]
  • Change in Cardiorespiratory Fitness [Time frame: Baseline and 16 Weeks]
  • Change in dietary quality [Time frame: Baseline to Week 16]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Virginia — Charlottesville

Identifiers

NCT: NCT07298915 · 302929

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗