Effects of Sitaglpitin on Endothelial Function During the OGTT in T2DM
- Registration Number
- NCT02301806
- Lead Sponsor
- Dokkyo Medical University
- Brief Summary
To investigate whether single administration of sitaglitpin can restore acute endothelial dysfunction and ameliorate impaired increase of the number of endothelial progenitor cells (EPCs) after oral glucose loading in patients with T2DM.
To compare the effect of sitagliptin and glimepiride on endothelial function evaluated by flow-mediated vasodilatation (FMD) and the number of circulating EPCs in patients with T2DM.
- Detailed Description
Acute and chronic improvement of endothelial function is expected through the pleiotropic effect of DPP-4 inhibitors. A randomized, prospective, open-labeled, parallel design. The duration of treatments with sitagliptin or glimepiride is 12 weeks. The number of study centers is a single (Dokkyo Medical University Hospital). Participants will be randomized into the two treatment groups; (a) 50mg sitagliptin (N=15) and (b) 1mg glimepiride (N=15).
Anti-Hyperglycemic effect is expected to be similar according to our study
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Provision of informed consent before any study specific procedures
- Type II diabetes who have inadequate glycaemic control (6.5%≦HbA1c<9.0%)
- Age from 20 to 80 years old
- No history of using any antihyperglycemic drugs
- No history of cardiovascular complications
- No treatment or treatment with stable doses of lipid-lowering, antihypertensive, and antiplatelet agents for at least 3 months prior to randomization
- 4.5 % ≤ fasting FMD at baseline < 8.0 %
-
・Type I diabetes
- Pregnancy
- Liver disease (hepatic enzymes more than three times the upper limit of normal ranges)
- Impairared kidney function (serum crearinine greater than 1.3 mg/dl in men, 1.2 mg/dl in women)
- Cigarette smokers
- Contraindications to glimepiride and sitagliptin
- Active proliferative diabetic retinopathy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sitagliptin dieting sitagliptin 50 mg tablet by mouth 12 weeks Sitagliptin Sitagliptin sitagliptin 50 mg tablet by mouth 12 weeks Glimepiride dieting glimepiride 1 mg tablet by mouth 12 weeks Glimepiride Glimepiride glimepiride 1 mg tablet by mouth 12 weeks
- Primary Outcome Measures
Name Time Method Change in endothelial function during the OGTT evaluated by flow-mediated vasodilatation (FMD). The change is defined as below, assuming the peak value and changes of FMD will be observed at t=60 min. 12 weeks
- Secondary Outcome Measures
Name Time Method Change in endothelial function during OGTT* evaluated by endo-PAT. Change in endothelial function after 12-week treatment at the fasting state evaluated by endo-PAT and FMD. 12 weeks
Trial Locations
- Locations (1)
Dokkyo Medical University
🇯🇵Mibu, Tochigo, Japan