Effect of Semaglutide and Tirzepatide Combined With Exercise in Obesity

ConditionObesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-60
SponsorIstanbul Galata University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Semaglutide

    Drug

    They will use only semaglutide.

  • Tirzepatide

    Drug

    They will use only tirzepatide.

  • Tirzepatide+Exercise

    Behavioral

    This group will engage in exercise and receive tirzepatide therapy."

  • Semaglutide+Exercise

    Behavioral

    This group will engage in exercise and receive semaglutide therapy."

Treatment groups

48 Participants
are divided into 4 treatment groups
Group A: ARM 1-SemaglutideExperimental treatment 1 intervention
Group B: ARM 3-Semaglutide + ExerciseExperimental treatment 1 intervention
Group C: ARM 4-Tirzepatide + ExerciseExperimental treatment 1 intervention
Group D: ARM 2-TirzepatideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Body fat-muscle ratios (Body composition)

These measurements will be determined by bioelectrical impedance.

Time frame
Three months

Secondary outcomes

1

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).

Time frame
Three months
2

Glucose profile

Glucose profile after 12 hours of fasting will be measured. (mg/dL)

Time frame
Three months
3

Functional capacity

Submaximal functional exercise capacity of the participants will be evaluated with the six-minute walk test.

Time frame
Three months
4

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).

Time frame
Three months

Other outcomes

Sponsors and contacts

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Istanbul Galata University

Lead sponsor

Biruni University

Collaborator

Istanbul University

Collaborator

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