GLP-RA , DIABETIC , NON-DIABETIC , BMI ,TYG-index , HDL-C
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- change in body weight at 3 and 6 months
研究概览
简要总结
titel : Comparative Study of Different Weekly GLP-1 Receptor Agonists Among Diabetic and Non-Diabetic Patients: Clinical Trial
Abstract :
Background: This study that highlights the different effects of most used three GLP-RA Dulaglutide, Semaglutide, Tirazepetide among diabetic and non -diabetic participant as the well-known fact that they don't have only weight recuing effect but also many different effects on metabolic process including insulin sensitivity, lipid profile and NASH.
Materials and Methods:
This is a randomized controlled study involving a total of 159 participants, divided into 75 non-diabetic and 84 diabetic obese individuals. Participants were assigned to three drug groups, each receiving a once-weekly dose of Dulaglutide, Semaglutide, or Tirzepatide for a period of 24 weeks. Each drug group consisted of 53 individuals, subdivided into 25 non-diabetic and 28 diabetic participants.
Measurements were taken at three time points: pretreatment, 3 months post-treatment, and 6 months post-treatment. Each participant underwent a complete physical exam, and data was collected on weight, BMI, age, and sex and Laboratory tests. , also repeated measurements were taken at 3 and 6 months post-treatment. on metabolic processes, weight reduction, and insulin sensitivity, particularly in diabetic individuals, as well as effects on lipid profiles and liver enzymes, weight reduction, BMI, HbA1c, TYG-index, triglycerides, and HDL-C levels. total cholesterol (Tc) and liver enzymes.
Data were collected, and statistical analyses were conducted afterward.
详细描述
Methods
Study and population:
This was a randomized controlled clinical trial study conducted at Al-Zafer hospital Najran KSA October 2025. The study received approval from the Institutional Ethics Committee (king Khaled hospital) Najran health cluster KSA on 27 October 2024. IRB registration number with KACST, KSA: H-11-N-136.
Definition of overweight and obesity in adults using Body mass index (BMI): BMI ≥ 25 kg/m² (overweight) and BMI ≥ 30 kg/m² (obesity).
Formula: Body mass index, kg/m2 = weight, kg / (height, m)2 [24] Facts & Figures Simental-Mendia et al. (2008) developed the TyG (Triglyceride-Glucose Index), a mathematical equation that indirectly evaluates IR based on laboratory data: fasting plasma triglycerides and glucose levels [25].
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •overweight or obese, diabetic, or non-diabetic
排除标准
- •Patients who will refuse to be enrolled in the study or refuse to sign the consent
研究组 & 干预措施
obese , non diabetic ,recieve dulaglutide
GLP1-RA
干预措施: Dulaglutide 0.75mg subcutaneous injection (Drug)
obese , non diabetic ,receive SEMAGLUTIDE
GLP1-RA
干预措施: Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution (Drug)
obese , non diabetic ,receive TIRAZEPETIDE
GLP1-RA
干预措施: Tirzepatide is administered as part of routine clinical care for obesity management, according to standard prescribing practices. Dosing and treatment duration are determined by the treating physician (Drug)
obese , non diabetic ,receive TIRAZEPETIDE
GLP1-RA
干预措施: Tirzepatide (Flexible titration) (Drug)
obese , diabetic ,receive SEMAGLUTIDE
GLP1-RA
干预措施: Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution (Drug)
obese , diabetic ,receive TIRAZEPETIDE
GLP1-RA
干预措施: Tirzepatide is administered as part of routine clinical care for obesity management, according to standard prescribing practices. Dosing and treatment duration are determined by the treating physician (Drug)
obese , diabetic ,receive TIRAZEPETIDE
GLP1-RA
干预措施: Tirzepatide (Flexible titration) (Drug)
obese , non diabetic ,recieve dulaglutide
GLP1-RA
干预措施: Dulaglutide 1.5 MG/ML (Drug)
obese , diabetic ,receive SEMAGLUTIDE
GLP1-RA
干预措施: Semaglutide 1.0 mg (Drug)
obese , diabetic ,recieve dulaglutide
GLP1-RA
干预措施: Dulaglutide 1.5 MG/ML (Drug)
obese , non diabetic ,receive SEMAGLUTIDE
GLP1-RA
干预措施: Semaglutide 1.0 mg (Drug)
结局指标
主要结局
change in body weight at 3 and 6 months
时间窗: 6-MONTH STUDY PERIOD
Change from baseline in body weight (kg) at 3 and 6 months among diabetic and non-diabetic participants receiving weekly GLP-1 receptor agonists.
次要结局
- Change in Body Mass Index (BMI)(3 months, and 6 months)
- Change in Glycated Hemoglobin (HbA1c)(Baseline, 3 months, and 6 months)
- Change in Low-Density Lipoprotein Cholesterol (LDL-C)(Baseline, 3 months, and 6 months)
- Change in Triglycerides(Baseline, 3 months, and 6 months)
- Change in Alanine Aminotransferase (ALT)(Baseline, 3 months, and 6 months)
- Change in Aspartate Aminotransferase (AST)(Baseline, 3 months, and 6 months)
- Change in High-Density Lipoprotein Cholesterol (HDL-C)(Baseline, 3 months, and 6 months)
- Change in Total Cholesterol (TC)(Baseline, 3 months, and 6 months)
研究者
Osama Ibraheem husini Moustafa
Dr.
Zagazig University