Subject: Renal Function Parameters in Indian patients with Type 2 Diabetes Mellitus on oral antidiabetic agents (REDORA-III) - A multicenter, retrospective, cross sectional study
The kidney is arguably the most important target of microvascular damage in diabetes. A substantial proportion of individuals with diabetes will develop kidney disease owing to their disease and/or other co- morbidity, including hypertension and ageing-related nephron loss. Thus, preventing and managing CKD in patients with diabetes is now a key aim of overall management of diabetes
Guidelines recommend that diabetic patients should undergo annual testing for kidney function using serum creatinine-based eGFR and urine tests for abnormal levels of albumin excretion to evaluate presence of any dysfunction. The history of glycemic and blood pressure control should also be considered as factors predisposing to diabetic kidney disease in patients with longstanding diabetes
Age, duration of diabetes, ethnicity, and family history diabetes, hypertension & kidney disease are some of the non-modifiable risk factors, while obesity, uncontrolled diabetes, dyslipidemia, and hypertension are some of modifiable risk factors that have been identified.
KDOQI guidelines recommends all patients with type 2 diabetes should have their renal function screened at least annually post diagnosis, using both ACR and eGFR. More frequent monitoring is appropriate for individuals with established renal impairment and those at increased risk of progressive kidney disease
Several glucose-lowering agents are purported to have pleiotropic Reno protective actions in patients with diabetes and CKD beyond glucose lowering These drugs include metformin, dipeptidyl peptidase 4 (DPP4) inhibitors, glucagon-like peptide 1 (GLP1) analogues, thiazolidinediones and sodium/glucose co-transporter 2 (SGLT2) inhibitors
The present study is planned to evaluate effect of duration of diabetes and associated risk factors on renal function, and also understand utilization pattern of antidiabetic drugs in T2DM with CKD.
We invite you to participate in this study. On acceptance, you will need to capture the relevant data as mentioned in the standard Data Collection Form (DCF) provided, from the patient's medical records (case papers and investigational reports - hereafter referred as source documents).
We would recommend you to capture data fulfilling the criteria as outlined in the protocol and whose relevant laboratory investigations are available for the preceding 3 months.
We wish to inform you that the DCF will capture all data in de-identified form and any identifiable parameters which may potentially disclose the identity of the patient such as name or address will strictly not be captured so as to ensure we maintain patient confidentiality. We would encourage you to carefully fill all available information to the fullest as recommended in the DCF.
In alignment with good clinical research practices, an independent Contract Research Organization (CRO) will monitor this study and do the source data verification of the data captured in the DCF with copies of the patients' source medical records (case papers and investigational reports) to ensure that the data entered in the DCFs are accurate and in alignment with the patients' medical records. The study is approved by independent ethics committee.
If you agree to participate in the said study, we would request you to sign and return the enclosed reply along with your visiting card for accuracy of records.
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