NCT Number: NCT07319975
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.
Trial opening soon.
Get Notified25 year–60 year
All sexes
Interventional
Not applicable
Istanbul, Zeytinburnu, Turkey (Türkiye)
Alihan Oral, PhD
SUB_INVESTIGATOR
Buket Akinci, Associate Professor, PhD
CONTACT
Buket Akinci, PhD
SUB_INVESTIGATOR
Busra Ulker Eksi, PhD
SUB_INVESTIGATOR
Fulya Calikoglu, PhD
SUB_INVESTIGATOR
Safak Yigit, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
They will use only semaglutide.
They will use only tirzepatide.
This group will engage in exercise and receive tirzepatide therapy."
This group will engage in exercise and receive semaglutide therapy."
Time frame: Three months
These measurements will be determined by bioelectrical impedance.
Time frame: Three months
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).
Time frame: Three months
Glucose profile after 12 hours of fasting will be measured. (mg/dL)
Time frame: Three months
Submaximal functional exercise capacity of the participants will be evaluated with the six-minute walk test.
Time frame: Three months
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).
Time frame: Three months
Respiratory muscle strength; It will be evaluated with an intraoral pressure measuring device in a sitting position.
Time frame: Three months
Step Count Measurement: Daily step count will be monitored to determine the physical activity level of the participants. Step count will be assessed with a wearable activity monitor, a portable, easy-to-use tool that can measure objectively (Huawei Watch Fit Special Edition). With its six-axis sensor, the device records the user's physical activity style information in its temporary memory throughout the duration of use. Participants will be asked to wear the activity monitor on their left wrist throughout and only remove it during bathing. After one week of use, the data recorded with the wearable activity monitor will be taken.
Time frame: Three months
Respiratory muscle endurance will be evaluated by incremental load test. The incremental load test will be performed using the electronic inspiratory loading device (PowerBreathe®-KHP2).
Time frame: Three months
Lipid profile after 12 hours of fasting will be measured
Contact information is provided by the study sponsor or research team.
Istanbul Galata University
Other
Comparison of the Effects of Semaglutide and Tirzepatide Treatments in Combination With Exercise in Obesity Management
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