Effects of the DPP-4 Inhibitors or SGLT2 Inhibitors on the Protective Actions for Diabetic Complications
Conditions
Brief summary
Inhibition of dipeptidyl peptidase-4 (DPP-4) or sodium-glucose co-transporter type 2 (SGLT2) has been proposed as a therapeutic target for type 2 diabetes. However, how DPP-4 inhibitors or SGLT2 inhibitors exert protective actions for diabetic complications in addition to their glucose-lowering effects remains unknown.
Interventions
Sponsors
Kurume University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of type 2 diabetic patients * Must be able to swallow tablets * never received DPP-4 inhibitors or SGLT2 inhibitors
Exclusion criteria
* uncontrolled diabetes (fasting plasma glucose\>200 mg/dL) * receiving insulin therapy * hepatic disorders (2.5 fold or greater increases in aspartate transaminase or alanine transaminase levels above the upper limits of normal) * inflammatory disorders * neoplastic disorders * recent (\<3months) acute coronary syndrome and stroke * any acute infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effects of treatment on the nominal change in arterial stiffness from baseline after 6 months of treatment as measured by cardio-ankle vascular index | 6 months of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in subcutaneous and visceral fat volume | 6 months of treatment |
| Change from baseline in lipid profile including malondialdehyde-modified low-density lipoprotein and remnant-like particle cholesterol | 6 months of treatment |
| Change from baseline in circulating inflammatory markers | 6 months of treatment |
Countries
Japan
Contacts
Primary ContactNobuhiro Tahara, MD, PhD
Outcome results
None listed