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Dear
Dr. {{ $doctorName }},
Subject:
{{ $ActivityName }}
Diabetes is the leading
cause of chronic kidney disease (CKD) and end-stage kidney disease
(ESKD) in India. Diabetic kidney disease is a clinical diagnosis
based upon the presence of albuminuria, decreased estimated
glomerular filtration rate (eGFR), or both, in diabetes. The average
annual rate of decline in eGFR due to age in otherwise healthy
individuals is 0.5-1 ml/min/1.73 m2 per year by third to
fourth
decade, but is more rapid in patients with long-standing diabetes.
Reduced eGFR can also occur in the absence of albuminuria.
Progression of diabetic kidney disease appears to be slower in
patients with non-albuminuric disease. However, patients with
non-albuminuric CKD have a high risk for eventual progression, even
if slower than in patients with albuminuric disease. While the
decline of kidney function in diabetes is well established, defining
the natural history of kidney function decline is difficult and
variable because of inter-individual variability, clinical risk
factors, and use of effective therapies to slow progression.
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
taken into account as factors predisposing to diabetic kidney
disease in patients with longstanding diabetes. The most common
agents used to slow the decline in renal function include the RAAS
blockers, and recently, SGLT22 inhibitors have
demonstrated their
effectiveness in several trials. SGLT2 inhibitors have
been shown to
be useful even among patients whose eGFR ultimately falls below 30
mL/min/1.73 m2. The absolute risk reduction with these
agents is
greater among those with severely increased albuminuria, since such
patients have a higher absolute risk of developing a major kidney
event. The data on the renal function parameters in Indian diabetic
patients on oral anti-diabetic agents with or without co-morbidities
affecting kidney function is sparse. Early detection of CKD is
critical to slow the disease progression, prevent long term
morbidity and mortality.
Thus in lieu of the above
the present study is planned to evaluate renal function parameters
in Indian diabetic patients on oral anti-diabetic agents.
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 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.
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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