NCT05905965招募中3 期
Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment (DEMETER - SIRIO 11) Study
Collegium Medicum w Bydgoszczy1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- concentration of HbA1c (glycated hemoglobin)
研究概览
简要总结
The DEMETER - SIRIO 11 study is a phase III, multicenter, randomized, open-labled, investigator-initiated clinical trial with a 6 month follow-up.
The study population will include 200 subjects with diagnosis of metabolic syndrome.
All enrolled patients (nn=200) will be randomly assigned in 1:1 ratio to one of the two study arms:
- Empagliflozin 20 mg - experimental arm
- Empagliflozin 10 mg - control arm. Primary co-endpoints of the study include: BMI and HbA1c. Secondary endpoints include: LDL-C, triglycerides, CRP, NT-proBNP, LVEF (echocardiography), body composition, VO2max (ergospirometry), waist-hip ratio (WHR), liver steatosis assessment (LSA) by computed tomography (CT), major adverse cardiovascular events - MACE (based on medical history: heart attack, stroke, death), cardiovascular hospitalizations.
详细描述
The DEMETER - SIRIO 11 study is a phase III, multicenter, randomized, open-labled, investigator-initiated clinical trial with a 6 month follow-up.
The study population will include 200 subjects with diagnosis of metabolic syndrome.
All enrolled patients (nn=200) will be randomly assigned in 1:1 ratio to one of the two study arms:
- Empagliflozin 20 mg - experimental arm
- Empagliflozin 10 mg - control arm.
Primary co-endpoints of the study include: BMI and HbA1c.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of metabolic syndrome as follows: the presence of obesity (waist circumference ≥ 88 cm in women; ≥102 cm or body mass index (BMI) ≥30 kg/m2) and two of the three following criteria:
- •high blood pressure (systolic blood pressure - in-office measurement: ≥ 130 and/or diastolic blood pressure ≥85 mm Hg or systolic blood pressure - ambulatory measurement: ≥130 and/or diastolic blood pressure ≥ 80 mm Hg) or on anti-hypertensive treatment;
- •impaired glucose metabolism (fasting glucose ≥100 mg/dL or ≥ 140 mg/dL after 120 min in oral glucose tolerance test or HbA1c ≥5.7%) or on glucose-lowering drug treatment;
- •elevated non-high-density lipoprotein (non-HDL ≥130 mg/dL) cholesterol level (atherogenic dyslipidemia) or on lipid-lowering drug treatment
排除标准
- •current treatment with SGLT2 inhibitor
- •chronic kidney disease with estimated glomerular filtration rate (eGFR) < 30 mL/min or on dialysis
- •severely impaired liver function
- •known hypersensitivity to the active empagliflozin or to any of the excipients contained in Jardiance
- •history of ketoacidosis
- •diabetes treated with insulin
- •pregnancy
- •decompensated heart failure
- •acute coronary syndrome
- •active thromboembolic disease
- •current treatment for neoplastic disease
- •active inflammatory disease within 1 month prior to enrollment
- •expected lifetime <1 year
- •non-cooperative patients
研究组 & 干预措施
Empagliflozin 20 mg
Experimental
Patients receiving empagliflozin 20 mg daily
干预措施: Empagliflozin 20 mg (Drug)
Empagliflozin 10 mg
Active Comparator
Patients receiving empagliflozin 10 mg daily
干预措施: Empagliflozin 10 mg (Drug)
结局指标
主要结局
concentration of HbA1c (glycated hemoglobin)
时间窗: 0-6 months
change in glycated hemoglobin plasma concentration between study arms
BMI (Body Mass Index)
时间窗: 0-6 months
change in BMI between study arms
次要结局
- concentration of NT-proBNP(0-6 months)
- LVEF - left ventricle ejection fraction (echocardiography)(0-6 months)
- body composition analysis - total body water [%](0-6 months)
- liver steatosis assessment (LSA) by computed tomography (CT)(0-6 months)
- body composition analysis - lean body mass [%](0-6 months)
- body composition analysis - extracellular water [liters](0-6 months)
- concentration of CRP (c-reactive protein)(0-6 months)
- body composition analysis - body fat mass [%](0-6 months)
- body composition analysis - extracellular water [%](0-6 months)
- body composition analysis - hydration [%](0-6 months)
- concentration of LDL-C (low density cholesterol serum concentration)(0-6 months)
- concentration of triglycerides(0-6 months)
- body composition analysis - body fat mass [kg](0-6 months)
- body composition analysis - lean body mass [kg](0-6 months)
- body composition analysis - skeletal muscle mass [kg](0-6 months)
- body composition analysis - total body water [liters](0-6 months)
- body composition analysis - visceral fat level [liters](0-6 months)
- level of maximal oxygen uptake (VO2max) measured in ergospirometry(0-6 months)
- major adverse cardiovascular events - MACE(0-6 months)
- cardiovascular hospitalizations(0-6 months)
- waist-hip ratio (WHR)(0-6 months)
研究者
Jacek Kubica
Prof. dr hab.
Collegium Medicum w Bydgoszczy
研究点 (1)
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