Type 2 Diabetes Mellitus
Conditions
Keywords
Dapagliflozin, Empagliflozin, FMD, T2DM, Endothelial disfunction
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.
Interventions
DRUGDapagliflozin Pill
The patient will take one pill, every 24 hr, during 7 days
DRUGEmpagliflozin Pill
The patient will take one pill, every 24 hr, during 7 days
DRUGPlacebo pill
The patient will take one pill, every 24 hr, during 7 days
Sponsors
Centro Universitario de Ciencias de la Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow Mediated Dilation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total cholesterol | 7 days | Before and after intervention, using the BioSystems® Glucose Oxidase / Peroxidase kit. |
| Triglycerides | 7 days | Before and after intervention, using the BioSystems® Glycerol phosphate Oxidase / Peroxidase kit. |
| High-density lipoprotein cholesterol | 7 days | Before and after intervention, using the BioSystems® Direct / Detergent HDL kit |
| Fasting plasma glucose | 7 days | Before and after intervention, using the BioSystems® Glucose Oxidase / Peroxidase kit; in an automated clinical chemistry analysis equipment brand XL-100Erba |
| Creatinine | 7 days | Before and after intervention the BioSystems® kit Modified Jaffe's no deproteinization |
| Blood pressure | 7 days | Before and after intervention using an OMRON calibrated electronic digital sphygmomanometer model HEM 907 XL will be used. The patient will remain seated in a chair resting his back on the backrest, with a minimum rest of 5 minutes, The average of 3 measurements such as BP will be taken |
| Low-density lipoprotein cholesterol | 7 days | Before and after intervention using the BioSystems® Cholesterol Oxidase / Peroxidase kit |
Countries
Mexico
Contacts
Primary ContactFernando Grover Paez, PhD
Outcome results
None listed