Comparison of the Effects of Semaglutide and Tirzepatide Treatments in Combination With Exercise in Obesity Management
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Body fat-muscle ratios (Body composition)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Individuals with a history of lower extremity injury or surgery in the last six months
- •Diagnosed with diabetes and complications such as nephropathy, retinopathy, and neuropathy
- •Individuals with concomitant chronic respiratory disease
- •Individuals with acute infections
- •Individuals with middle ear pathologies (such as tympanic membrane rupture, otitis media)
- •Individuals with a history of spontaneous or trauma-related pneumothorax
- •Pregnancy
- •Individuals with a STOP-bang score of 3 or higher
- •Individuals on a structured diet program for weight loss during the study period
- •Individuals who have had endoscopic intervention and/or bariatric surgery within the last year
研究组 & 干预措施
ARM 1-Semaglutide
Drug: Semaglutide
干预措施: Semaglutide (Drug)
ARM 3-Semaglutide + Exercise
干预措施: Semaglutide+Exercise (Behavioral)
ARM 4-Tirzepatide + Exercise
干预措施: Tirzepatide+Exercise (Behavioral)
ARM 2-Tirzepatide
Drug: Tirzepatide
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Body fat-muscle ratios (Body composition)
时间窗: Three months
These measurements will be determined by bioelectrical impedance.
次要结局
- Peripheral muscle strength(Three months)
- Glucose profile(Three months)
- Functional capacity(Three months)
- Pulmonary function(Three months)
- Incremental load test (Respiratory Muscle Endurance)(Three months)
- Respiratory muscle strength(Three months)
- Physical activity level(Three months)
- Lipid Profile(Three months)
研究者
Safak Yigit
Assistant Professor
Istanbul Galata University