Diabetes Mellitus, Endothelial Dysfunction
Conditions
Keywords
Endothelial dysfunction, Diabetes mellitus, glimepiride, metformin
Brief summary
The Purpose of this study was to evaluate the effect of the combination glimepiride/metformin over endothelial dysfunction (ED) in asymptomatic patients with type 2 diabetes mellitus (DM) using 13N-ammonia-positron emission tomography (PET).
Interventions
4/1000 mg tablets once a day foe eight weeks
DRUGMetformin
1000 mg tablets once daily for eight weeks
Sponsors
Laboratorios Silanes S.A. de C.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Both genders * At least 18 years old * Type 2 diabetes mellitus diagnosis * Signed Informed Consent
Exclusion criteria
* History of smoking, hypertension, dyslipidemia, ischemic heart disease or autoimmune rheumatic diseases * Pregnancy or lactation * History of abuse and/or substance dependence within 6 months preceding the survey. * History of glimepiride or metformin allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EDVI | 8 weeks | endothelial-dependent vasodilation index |
| MFR | 8 weeks | myocardial flow reserve |
| %ΔMBF | 8 weeks | percentage of the change between rest and CPT |
Secondary
| Measure | Time frame |
|---|---|
| Fasting glucose | 8 weeks |
| Glycated hemoglobin | 8 weeks |
| Adverse effects | 8 weeks |
Countries
Mexico
Outcome results
None listed