Acute Effect of Empagliflozin vs Dapagliflozin vs Placebo Administration Over Pulse Wave Velocity in Patients With Type Two Diabetes
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Pulse wave velocity
研究概览
简要总结
To date one of the main independent biomarkers of cardiovascular disease is the arterial stiffness parameters measured by carotid-femoral pulse wave velocity. It is known that SGLT2 inhibitors develop cardiac protection over long term administration, but there's not enough studies about acute effects in early administration.
详细描述
Measure basal carotid-femoral Pulse Wave Velocity through a Pulse Pen tonometer by DiaTecne among basic physical examination, blood test, anthropometric and hemodynamic measurements; then administrate randomly dapagliflozin 10 mg, empagliflozin 25 mg or placebo for 7 days and then perform all of the measurements and blood test again.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of T2DM
- •HbA1c > 7 y < 10
- •BMI 25 - 34.9 kg/m2
- •Signature of consent under information
排除标准
- •Hypertension
- •Treated with insulin and / or loop diuretics and thiazides
- •Hypotension
- •Any autoimmune disease
- •Liver disease
- •Women whitout birth control method
- •Women taking oral birth control or under hormone replacement therapy
- •Woman pregnant or breastfeeding
- •Untreated thyroid disease
- •Patients with a cardiovascular disease that contraindicates the use of this pharmacological class
- •Glomerular filtration rate <60ml/min (Cockcroft-Gault)
研究组 & 干预措施
Dapagliflozin 10 mg
Dapagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to a sodium-glucose cotransporter 2 (SGLT2) inhibitors.
干预措施: Dapagliflozin 10Mg Tab (Drug)
Empagliflozin 25 mg
Empagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to sodium-glucose cotransporter 2 (SGLT2) inhibitors.
干预措施: Empagliflozin 25 MG (Drug)
Placebo
Calcinated magnesium is a white powdery compound, MgO, used in pharmaceuticals as binder.
干预措施: Placebo (Other)
结局指标
主要结局
Pulse wave velocity
时间窗: 7 days
Change from baseline carotid-femoral pulse wave velocity at 7 days. Using a PulsePen tonometer by DiaTechne.
次要结局
- Total cholesterol(7 days)
- Low-density lipoprotein cholesterol(7 days)
- Creatinine(7 days)
- Fasting plasma glucose(7 days)
- Triglycerides(7 days)
- High-density lipoprotein cholesterol(7 days)
- Blood pressure(7 days)
研究者
Fernando Grover Paez
Principal Investigator
Centro Universitario de Ciencias de la Salud, Mexico