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临床试验/NCT04195243
NCT04195243Unknown3 期

Acute Effect of Dapagliflozin vs Empagliflozin Administration on Flow Mediated Dilation in Patients With Type 2 Diabetes Mellitus

Centro Universitario de Ciencias de la Salud, Mexico1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年12月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
24
试验地点
1
主要终点
Flow Mediated Dilation

研究概览

简要总结

Type 2 diabetes mellitus (T2DM) is a considered one of the main global health challenges; the vascular endothelium plays an important role in vascular dysfunction in DM; Hyperglycemia induced by it is recognized as the main factor for the development of vascular complications of the disease, secondary to a reduction in nitric oxide production; "flow-mediated dilation" is the most commonly used technique for the evaluation of endothelial function, being the non-invasive method most widely used. It has been reported that with the use of SGLT2 inhibitors the development of cardiovascular complications in patients with T2DM is a decrease, as well the arterial stiffness, endothelial dysfunction and increasing on the shear stress and blood viscosity; and experimentally.

详细描述

The objective of this study, is to evaluate the acute effect of the administration of dapagliflozin in comparison with the administration of empagliflozin on endothelial disfunction in individuals with T2DM; we will conduct a double-blind, randomized, placebo-controlled, trial with 3 groups, each group of 24 male and female patients, between 40-65 years of age with T2DM, without hypertension, treated with insulins or thiazide diuretics. Randomization will determine who will receive the intervention during 7-days trial (Empagliflozin 25 mg 1 time daily 5 minutes or Dapagliflozin 10 mg before the first bite of each meal or approved placebo capsules), the patients will also continue with their usual treatment. The clinical findings and laboratory test and laboratory test include a metabolic profile and biosafety, baseline and at 7 days. Body weight, body fat, body mass index (BMI) and blood pressure will be determined during the initial and final visit, likewise, hemodynamics parameters of endothelial disfunction by flow mediate dilation with a high-resolution UNEX EF38G® ultrasound. Adverse events to treatment will be documented. Statistical analysis: Mann-Whitney U Test and Wilcoxon exact test. A p <0.05 will be considered statistically significant.

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
Single (Outcomes Assessor)

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

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
  • With any autoimmune disease
  • Liver disease
  • Women who do not have a safe method of contraception
  • Women who are taking oral contraceptives or under treatment with 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

Experimental

Individuals with T2DM controlled with metformin; with no hypertension neither treated with insulin.

Dapagliflozin capsules, 10 mg 1 time daily 5 minutes before the first meal

干预措施: Dapagliflozin Pill (Drug)

Empagliflozin

Experimental

Individuals with T2DM controlled with metformin; with no hypertension neither treated with insulin.

Empagliflozin capsules, 25 mg 1 time daily 5 minutes before the first meal

干预措施: Empagliflozin Pill (Drug)

Placebo

Placebo Comparator

Individuals with T2DM controlled with metformin; with no hypertension neither treated with insulin.

Dapagliflozin capsules, 400 mg 1 time daily 5 minutes before the first meal

干预措施: Placebo pill (Drug)

结局指标

主要结局

Flow Mediated Dilation

时间窗: 7 days

Change from baseline Flow mediated dilation at 7 days. Using a high-resolution UNEX EF38G ultrasound®, in a room at 22°C, with the patient lying supine, and the right arm extended

次要结局

  • Fasting plasma glucose(7 days)
  • Total cholesterol(7 days)
  • Triglycerides(7 days)
  • High-density lipoprotein cholesterol(7 days)
  • Low-density lipoprotein cholesterol(7 days)
  • Creatinine(7 days)
  • Blood pressure(7 days)

研究者

发起方
Centro Universitario de Ciencias de la Salud, Mexico
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernando Grover Paez

Investigador Principal

Centro Universitario de Ciencias de la Salud, Mexico

研究点 (1)

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