Diabetic Nephropathies
Conditions
Keywords
Gemigliptin, Diabetic Nephropathy, Acute Kidney Injury, Vascular Calcification
Brief summary
Dipeptidyl peptidase-4 (DPP-4) inhibitors improve glycemic control and contain pleiotropic actions on kidney injury, albuminuria and vascular inflammation especially in animal models. We plan to evaluate the efficacy of potent DPP4-inhibitors (gemigliptin) in response to these aspects in diabetic nephropathy patients.
Detailed description
This is a multi-center, prospective, randomized, placebo-controlled trial. A total of 201 participants were enrolled and randomly assigned to gemigliptin 50 mg daily and standard care of diabetes mellitus for 6 months. The changes of coronary calcium score (CAC score), cardio-ankle vascular index (CAVI), estimated glomerular filtration rate (GFR), markers of vascular calcification and markers of tubular renal injury were evaluated at baseline and 6 months.
Interventions
DRUGGemigliptin
We collected baseline data from all participants for demographic characteristics,comorbid conditions and biochemistry indexes.The biomarkers for vascular calcification and renal injury were collected.Baseline CAC score and CAVI were done.The patients then were randomized into 2 groups: Group 1 received gemigliptin 50 mg /day for 6 months in addition to standard treatment ,Group 2 will have standard treatment for diabetes mellitus (DM) and chronic kidney disease (CKD).The patients will be followed up every eight weeks.Fasting plasma glucose ,BUN creatinine and 24 hour urine protein were measured at each study visit.Patients were scheduled for follow-up visits at months 2,4,and 6.After 6 months ,all the blood tests,CAC score and CAVI will be done again.
Sponsors
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multi-center, prospective, randomized, placebo-controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with CKD stage 1-3 (eGFR 15-60 ml/min/1.73mL) * Non-insulin dependent diabetes mellitus , blood glucose level 30-250 mg/dL * Had clinical features compatible with diabetic nephropathy (urine micro albuminuria \> 30 g/g creatinine or has evidence of diabetic retinopathy
Exclusion criteria
* History of allergy to DPP4-inhibitor * Concurrent infectious disease * Inflammatory diseases * Post kidney transplantation * Receiving cinacalcet, bisphosphonate ,previously treated with DPP4-Inhibitors and sodium-glucose cotransporter-2 inhibitor (SGLT2-i).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Markers of renal injury | 6 months | urine NGAL/Cr,urine Kim-1/Cr,urine LFABP/Cr (pg/mL) |
| Markers of vascular calcification | 6 months | serum bone alkaline phosphatase(pg/mL),osteopontin (pg/mL) |
Countries
Thailand
Outcome results
None listed