About this trial
Obesity is a growing global health problem that affects people of all ages. It can lead to serious health issues such as cardiovascular disease, insulin resistance, inflammation, and reduced physical function. New medications, including GLP-1 receptor agonists like semaglutide and dual GLP-1/GIP agonists like tirzepatide, have been shown to help people lose significant weight. However, some of this rapid weight loss may come from a reduction in muscle mass rather than fat. Losing muscle can lower physical performance, impair metabolic health, and increase the risk of developing sarcopenic obesity. This study aims to compare the effects of pharmacological treatment alone with a combined treatment program that includes both medication and exercise in individuals with obesity. The primary objective is to evaluate how these two approaches influence body composition.
The secondary objective is to examine the effects of pharmacological treatment versus combined treatment on cardiometabolic markers, peripheral muscle strength, functional capacity, respiratory function, respiratory muscle performance, and physical activity levels. The study seeks to determine whether adding structured exercise to medication can provide additional health benefits beyond weight loss.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Those between the ages of 25 and 60 years
Those with a body mass index (BMI) between 30 and 40 kg/m2 according to the World Health Organization (WHO) classification
Individuals who volunteered to participate in the study
Disqualifiers
Individuals with a BMI greater than 40 kg/m2 according to the WHO classification
Individuals with a Charlson comorbidity index score of 3 or higher
Uncontrolled arrhythmia, hypertension, heart failure, diabetes, and unstable angina pectoris
Cooperation impairment, orthopedic, and neurological problems that may interfere with evaluation and treatment
Trial design
Parallel
Treatments tested in this trial
Semaglutide
DrugThey will use only semaglutide.
Tirzepatide
DrugThey will use only tirzepatide.
Tirzepatide+Exercise
BehavioralThis group will engage in exercise and receive tirzepatide therapy."
Semaglutide+Exercise
BehavioralThis group will engage in exercise and receive semaglutide therapy."
Treatment groups
Trial outcomes
Primary outcomes
Body fat-muscle ratios (Body composition)
These measurements will be determined by bioelectrical impedance.
Secondary outcomes
Peripheral muscle strength
M. Quadriceps muscle strength and hand grip strength measurement will be used to evaluate peripheral muscle strength (kg). Hand-held dynamometer will be used to evaluate quadriceps muscle strength and hand grip strength (kg).
Glucose profile
Glucose profile after 12 hours of fasting will be measured. (mg/dL)
Functional capacity
Submaximal functional exercise capacity of the participants will be evaluated with the six-minute walk test.
Pulmonary function
Spirometric assessment will be performed to determine participants' forced expiratory volume in one second (FEV1). Spirometric assessment will be performed to determine participants' forced vital capacity (FVC).
Sponsors and contacts
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