Dapagliflozin vs Empagliflozin on Flow Mediated Dilation in Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04195243
• Other study ID #: CUCS-INTEC-MV-HADES-001
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 2, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: December 2019
• Source: Centro Universitario de Ciencias de la Salud, Mexico
• Contact: Fernando Grover Paez, PhD
• Phone: (33) 10585200
• Email: fgroverp[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 30, 2020
• Est. primary completion date: June 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Dapagliflozin Pill
The patient will take one pill, every 24 hr, during 7 days
• Empagliflozin Pill
The patient will take one pill, every 24 hr, during 7 days
• Placebo pill
The patient will take one pill, every 24 hr, during 7 days

Locations

Country	Name	City	State
Mexico	Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitario de Ciencias de la Salud, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow Mediated Dilation	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	7 days
Secondary	Fasting plasma glucose	Before and after intervention, using the BioSystems® Glucose Oxidase / Peroxidase kit; in an automated clinical chemistry analysis equipment brand XL-100Erba	7 days
Secondary	Total cholesterol	Before and after intervention, using the BioSystems® Glucose Oxidase / Peroxidase kit.	7 days
Secondary	Triglycerides	Before and after intervention, using the BioSystems® Glycerol phosphate Oxidase / Peroxidase kit.	7 days
Secondary	High-density lipoprotein cholesterol	Before and after intervention, using the BioSystems® Direct / Detergent HDL kit	7 days
Secondary	Low-density lipoprotein cholesterol	Before and after intervention using the BioSystems® Cholesterol Oxidase / Peroxidase kit	7 days
Secondary	Creatinine	Before and after intervention the BioSystems® kit Modified Jaffe's no deproteinization	7 days
Secondary	Blood pressure	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	7 days