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NCT Number: NCT07818434

Prevalence of Renal Insufficiency in Patients With Type 2 Diabetes : A Retrospective Study.

the prevalence of renal insufficiency in patients with type 2 diabetes (T2D) visiting a large diabetes care center in Southern India. The prevalence estimates reported previously have shown variability to a large extent due to differences in selection criteria, cut-off values for diagnosis of renal insufficiency and the type of population selected.

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Key information

About this study

This was a retrospective cross-sectional analysis of data collected during 2022 and 2023 in patients with T2D and persistent renal insufficiency for at least a period of 3 months. The data was extracted from the electronic medical records of Dr.A. Ramachandran's Diabetes Hospitals, Chennai. We excluded patients with other forms of diabetes, renal complications (end stage renal disease, pylonephritis) and with missing data.

Patient records with the following data were included in the analysis. Anthropometry (height, weight and body mass index), systolic and diastolic blood pressure (measured thrice in a time-gap of 5 minutes each), laboratory parameters (fasting blood glucose, postprandial blood glucose, HbA1c, lipid profile (total cholesterol, triglycerides, HDL, LDL and VLDL) and renal function tests (serum creatinine, spot urine albumin to creatinine ratio)).

Renal insufficiency was defined as an eGFR of <60ml/min/1.73m2. calculated using the CKD EPI equation3. Presence of albuminuria was classified as microalbuminuria (UACR 30-300 mg/g) or macroalbuminuria (UACR > 300 mg/g). The cut-off values for assessing renal insufficiency were based on the Kidney Disease Outcomes Quality Initiative (KDOQI) recommendations 3.

Data was presented as mean ± SD for continuous variables and as n (%) for categorical variables. Intergroup differences between sub-categories of renal insufficiency were done using chi-square tests or Fisher's exact tests for categorical variables and student t-test or ANOVA for continuous variables.

To study the factors associated with renal insufficiency a logistic regression analysis was performed. The dependent variable was presence of renal insufficiency defined as an eGFR of <60ml/min/1.73m2 and or albuminuria ≥30 mg/g of creatinine. Independent variables included in the equation were age, duration of diabetes, gender, BMI, HbA1c, presence of hypertension, triglycerides, total cholesterol and HDLc. A p value of <0.05 was considered statistically significant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Type 2 diabetes patients who attended the outpatient department of the hospital during 2022 and 2023 will be included in the study.

Exclusion criteria

Type 1 Diabetes and other forms.

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Treatment and study plan

Primary outcomes

  1. Prevalence of renal insufficiency in type 2 diabetes

    Time frame: 1 Year

    To estimate the prevalence of renal insufficiency in patients with type 2 diabetes visiting a diabetes care centre in Southern India.

Secondary outcomes

  1. Prevalence of renal insufficiency in the following subcategories • Age • Gender • BMI • HbA1c • Hypertension

    Time frame: 6 months

    Anthropometric measurements (height, weight, body mass index), blood pressure, biochemical parameters (fasting blood glucose, postprandial blood glucose, HbA1c, lipid profile (total cholesterol, triglycerides, HDL, LDL and VLDL) and renal function test (creatinine, albumin creatinine ratio, proteinuria and eGFR)) will be included in the analysis.

    Renal insufficiency defined as: eGFR < 90 mL/min/1.73 m2, ≥ 90 mL/min/1.73 m2 with albuminuria or proteinuria

Sponsors and collaborators

Lead sponsor

India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

Other

Registry information

Acronym: CKD

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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