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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemigliptin group | Experimental | The participants will receive gemigliptin 50 mg daily |
|
| Control | Placebo Comparator | The control received standard care of diabetes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemigliptin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Markers of renal injury | urine NGAL/Cr,urine Kim-1/Cr,urine LFABP/Cr (pg/mL) | 6 months |
| Markers of vascular calcification | serum bone alkaline phosphatase(pg/mL),osteopontin (pg/mL) | 6 months |
| Markers of renal injury | Protienuria (mg/day) | 6 months |
| Markers of renal injury | eGFR (mL/min/1.73m2) | 6 months |
| Markers of vascular calcification | Reactive oxygen species (ng/mL) | 6 months |
| Markers of vascular calcification | CAVI,CAC score(unit) ,CAVI normal less than8 ,CAC score normal less than 100 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thananda Trakarnvanich, M.D. | Navamindradhiraj University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine ,Vajira Hospital | Bangkok | 10300 | Thailand | |||
| 2 Division of Nephrology,Department of Medicine Pramongkutklao Hospital and College of Medicine,Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34697593 | Derived | Trakarnvanich T, Satirapoj B, Suraamornkul S, Chirananthavat T, Sanpatchayapong A, Claimon T. Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibition on Biomarkers of Kidney Injury and Vascular Calcification in Diabetic Kidney Disease: A Randomized Controlled Trial. J Diabetes Res. 2021 Oct 16;2021:7382620. doi: 10.1155/2021/7382620. eCollection 2021. |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D058186 | Acute Kidney Injury |
| D061205 | Vascular Calcification |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C534891 | LC15-0444 |
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Multi-center, prospective, randomized, placebo-controlled trial
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|
|
| Bangkok |
| 10400 |
| Thailand |
| Department of Medicine,Police General Hospital,Thailand | Bangkok | 10500 | Thailand |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |