Health TrialsbyHealthPanel

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

ConditionObesity & Overweight
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age30-65
SponsorUniversity of Virginia

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Including but not limited to serious arrhythmias

Cardiomyopathy

Congestive heart failure

Stroke or transient ischemic attacks

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tirzepatide

    Drug

    Participants will take tirzepatide under the care of their primary care provider for 16 weeks

  • Exercise

    Behavioral

    Participants will perform a combination of aerobic and resistance training for 16 weeks

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: ExerciseExperimental treatment 2 interventions
Group B: Standard CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Weight

Measurement will be taken 3 times and measured in kg. A positive value indicates an increase in weight and a negative value indicates a reduction in weight

Time frame
Baseline and 16 Weeks

Secondary outcomes

1

Physical activity level

Physical activity will measured via accelerometry (total steps and light, moderate, vigorous physical activity) and steps for 7 consecutive days

Time frame
Baseline and 16 weeks
2

Changes in Blood Lipids Concentrations

A fasting blood sample will be used to measure low density lipoprotein, high density lipoprotein, total cholesterol, and triglycerides will be measured. It will be quantified as the specific amount of the lipoprotein within the blood in mg/dL for all lipid variables. Participants will be fasted at least 12 hours prior to the blood draw. Change will be quantified as the week 16 value subtracted from the baseline value. A positive value indicates an increase in the blood lipid variable and a negative value is associated with a reduction in the variable.

Time frame
Baseline to 16 weeks
3

Resting Metabolic Rate

Resting metabolic rate (RMR) will be measured in a quiet, temperature-controlled room using indirect calorimetry with a clear ventilated canopy and dilution pump. An increase represents a positive change and a decrease represents a negative change

Time frame
Baseline and 16 Weeks
4

Change in Fasting Glucose Level

Change in fasting glucose level. Fasting glucose level refers to the concentration of glucose within the blood (mg/dL). The change in fasting glucose level is quantified by subtracting the week 16 value from the baseline value. Thus, a positive value indicates an increase in glucose level and a negative value indicates a decrease in glucose.

Time frame
Baseline to 16 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: