Clinical trial NCT04195243: Dapagliflozin vs Empagliflozin on Flow Mediated Dilation in Type 2 Diabetes Mellitus
Official title: Acute Effect of Dapagliflozin vs Empagliflozin Administration on Flow Mediated Dilation in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Dapagliflozin
Empagliflozin
FMD
T2DM
Endothelial disfunction
Lead sponsor: Centro Universitario de Ciencias de la Salud, Mexico
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of T2DM
* HbA1c \> 7 y \< 10
* BMI 25 - 34.9 kg/m2
* Signature of consent under information

Exclusion Criteria:

* Hypertension
* Treated with insulin and / or loop diuretics and thiazides
* T1DM
* 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)

Primary outcomes:
measure: Flow Mediated Dilation
timeFrame: 7 days
Secondary outcomes:
measure: Fasting plasma glucose
timeFrame: 7 days
measure: Total cholesterol
timeFrame: 7 days
measure: Triglycerides
timeFrame: 7 days
measure: High-density lipoprotein cholesterol
timeFrame: 7 days
measure: Low-density lipoprotein cholesterol
timeFrame: 7 days
measure: Creatinine
timeFrame: 7 days
measure: Blood pressure
timeFrame: 7 days
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
state: Jalisco
Study officials:
affiliation: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS
name: Fernando Grover Paez, PhD
role: STUDY_DIRECTOR
References: