Diabetes Mellitus Type 2 Without Complication
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGDapagliflozin 10Mg Tab
Daily morning dose per oral of Dapagliflozin 10 mg for 7 days
DRUGEmpagliflozin 25 MG
Daily morning dose per oral of Empagliflozine 25 mg for 7 days
OTHERPlacebo
Daily morning dose per oral of Calcined magnesite 500 mg for 7 days
Sponsors
Centro Universitario de Ciencias de la Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
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 * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulse wave velocity | 7 days | Change from baseline carotid-femoral pulse wave velocity at 7 days. Using a PulsePen tonometer by DiaTechne. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total cholesterol | 7 days | Change from baseline, using the BioSystems® Glucose Oxidase / Peroxidase kit. |
| Triglycerides | 7 days | Change from baseline, using the BioSystems® Glycerol phosphate Oxidase / Peroxidase kit. |
| High-density lipoprotein cholesterol | 7 days | Change from baseline, using the BioSystems® Direct / Detergent HDL kit |
| Fasting plasma glucose | 7 days | Change from baseline, using the BioSystems® Glucose Oxidase / Peroxidase kit; in an automated clinical chemistry analysis equipment brand XL-100Erba |
| Creatinine | 7 days | Change from baseline, using the BioSystems® kit Modified Jaffe's no deproteinization |
| Blood pressure | 7 days | Change from baseline, using an OMRON calibrated electronic digital sphygmomanometer model HEM 907 XL. 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 | Change from baseline, using the BioSystems® Cholesterol Oxidase / Peroxidase kit |
Countries
Mexico
Outcome results
None listed