Diabetic Kidney DiseaseCKDNCT07818434
Prevalence of Renal Insufficiency in Patients With Type 2 Diabetes
An observational study of Diabetic Kidney Disease, run by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals at 1 site in India.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Kidney Disease
- How many people
- 12,000 participants
- Where
- 1 siteIndia
- Study dates
- 1 Feb 2022to 9 May 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who had visited the Diabetes care centre during the study period.
Who may be able to join
- Type 2 diabetes patients who attended the outpatient department of the hospital during 2022 and 2023 will be included in the study.
Who cannot join
- .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Diabetic Kidney Disease
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Persons with renal insuffiency | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of renal insufficiency in type 2 diabetes
To estimate the prevalence of renal insufficiency in patients with type 2 diabetes visiting a diabetes care centre in Southern India.
Measured: 1 Year
Secondary outcomes (1)
Prevalence of renal insufficiency in the following subcategories • Age • Gender • BMI • HbA1c • Hypertension
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Feb 2022
- Primary completion10 Mar 2024
- Study completion9 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 12,000 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818434
- Sponsor's protocol ID
- IDRFARH016
- Acronym
- CKD
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The patients had T2D and persistent renal insufficiency for at least a period of 3 months. Renal insufficiency was defined as an eGFR of \<60ml/min/1.73m2. and / or presence of microalbuminuria (UACR 30-300 mg/g) or macroalbuminuria (UACR \> 300 mg/g) based on the Kidney Disease Outcomes Quality Initiative (KDOQI) recommendations.
Publications
Hussain S, Habib A, Najmi AK. Limited Knowledge of Chronic Kidney Disease among Type 2 Diabetes Mellitus Patients in India. Int J Environ Res Public Health. 2019 Apr 23;16(8):1443. doi: 10.3390/ijerph16081443.
PubMed 31018581