An observational, cross-sectional study to assess the prevalence of chronic kidney disease in type 2 diabetes patients in India (START -India)
Objective: The primary objective of this study is to estimate the prevalence of chronic kidney disease (CKD) among type 2 diabetes mellitus (T2DM) patients in India. Materials and Methods: This cross-sectional, observational, epidemiological, multi-center, study is enrolling T2DM patients of either...
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doaj-0899a924cfb5449badab79405c68c4502020-11-24T21:03:45ZengWolters Kluwer Medknow PublicationsIndian Journal of Endocrinology and Metabolism2230-82102230-95002015-01-0119452052310.4103/2230-8210.157857An observational, cross-sectional study to assess the prevalence of chronic kidney disease in type 2 diabetes patients in India (START -India)M PrasannakumarRajesh RajputKrishna SeshadriPradeep TalwalkarPankaj AgarwalG GokulnathBhavesh KotakAmmar RazaHardik VasnawalaChirag TeliObjective: The primary objective of this study is to estimate the prevalence of chronic kidney disease (CKD) among type 2 diabetes mellitus (T2DM) patients in India. Materials and Methods: This cross-sectional, observational, epidemiological, multi-center, study is enrolling T2DM patients of either gender aged 30 years or above. This study aimed to enroll a total of 3000 T2DM patients at 30 participating hospitals/clinics across India and the data from a planned interim analysis of 1500 patients are presented here. The primary endpoint of the study is to estimate proportion of T2DM patients with CKD (glomerular filtration rate [GFR] <60 ml/min/1.73 m 2 or albumin creatinine ratio [ACR] ≥30 mg/g or ≥3 mg/mmol or both). Routine treatment, as administered by the treating physician, was continued without any study specific intervention. Patients′ data pertaining to demographic characteristics, medical history, current medication and physical examination were recorded. The blood/plasma and urine samples, were collected for estimation of hemoglobin A1c, microalbuminuria, serum creatinine, urine creatinine, and routine urine analysis. ACR was calculated from urine creatinine and albumin while GFR was estimated by using a modification of diet in the renal disease equation. Results: Study recruited 1500 patients from 18 centers across India. The study population included 840 (56.05%) males. Mean age, body mass index and systolic blood pressure were 55.1 years, 27.4 kg/m 2 and 134.5 mmHg respectively. The mean duration of diabetes was 102.2 months. History of co-morbid diseases such as dyslipidemia, hypertension, microvascular complications and macrovascular complications was present in 657 (43.8%), 655 (43.7%), 268 (17.9%) and 104 (6.93%), respectively. This interim analysis revealed that about 46% of the T2DM patients had CKD (urinary albumin creatinine ratio (UACR) ≥30 mg/g and/or estimated GFR [eGFR] <60 mL/min/1.73 m 2 ). The renal dysfunction as per eGFR criteria (<60 mL/min/1.73 m 2 ) was reported in about 23% while as per UACR criteria (≥30 mg/g) it was reported in about 35% patients. Conclusion: This interim analysis results suggests that over 40% of T2DM patients have CKD. Despite this high number of T2DM patients with CKD, eGFR analysis shows there are almost 80% of T2DM patients still have reasonably good renal function (eGFR above 60 ml/min), which ensures less restrictions in selecting oral anti-diabetic drugs. Full study results from Start-India study will provide detail insights into the occurrence of CKD in patients with T2DM in India.http://www.ijem.in/article.asp?issn=2230-8210;year=2015;volume=19;issue=4;spage=520;epage=523;aulast=PrasannakumarAlbumin creatinine ratiochronic kidney diseasediabetes mellitusglomerular filtration raterenal dysfunction |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
M Prasannakumar Rajesh Rajput Krishna Seshadri Pradeep Talwalkar Pankaj Agarwal G Gokulnath Bhavesh Kotak Ammar Raza Hardik Vasnawala Chirag Teli |
spellingShingle |
M Prasannakumar Rajesh Rajput Krishna Seshadri Pradeep Talwalkar Pankaj Agarwal G Gokulnath Bhavesh Kotak Ammar Raza Hardik Vasnawala Chirag Teli An observational, cross-sectional study to assess the prevalence of chronic kidney disease in type 2 diabetes patients in India (START -India) Indian Journal of Endocrinology and Metabolism Albumin creatinine ratio chronic kidney disease diabetes mellitus glomerular filtration rate renal dysfunction |
author_facet |
M Prasannakumar Rajesh Rajput Krishna Seshadri Pradeep Talwalkar Pankaj Agarwal G Gokulnath Bhavesh Kotak Ammar Raza Hardik Vasnawala Chirag Teli |
author_sort |
M Prasannakumar |
title |
An observational, cross-sectional study to assess the prevalence of chronic kidney disease in type 2 diabetes patients in India (START -India) |
title_short |
An observational, cross-sectional study to assess the prevalence of chronic kidney disease in type 2 diabetes patients in India (START -India) |
title_full |
An observational, cross-sectional study to assess the prevalence of chronic kidney disease in type 2 diabetes patients in India (START -India) |
title_fullStr |
An observational, cross-sectional study to assess the prevalence of chronic kidney disease in type 2 diabetes patients in India (START -India) |
title_full_unstemmed |
An observational, cross-sectional study to assess the prevalence of chronic kidney disease in type 2 diabetes patients in India (START -India) |
title_sort |
observational, cross-sectional study to assess the prevalence of chronic kidney disease in type 2 diabetes patients in india (start -india) |
publisher |
Wolters Kluwer Medknow Publications |
series |
Indian Journal of Endocrinology and Metabolism |
issn |
2230-8210 2230-9500 |
publishDate |
2015-01-01 |
description |
Objective: The primary objective of this study is to estimate the prevalence of chronic kidney disease (CKD) among type 2 diabetes mellitus (T2DM) patients in India. Materials and Methods: This cross-sectional, observational, epidemiological, multi-center, study is enrolling T2DM patients of either gender aged 30 years or above. This study aimed to enroll a total of 3000 T2DM patients at 30 participating hospitals/clinics across India and the data from a planned interim analysis of 1500 patients are presented here. The primary endpoint of the study is to estimate proportion of T2DM patients with CKD (glomerular filtration rate [GFR] <60 ml/min/1.73 m 2 or albumin creatinine ratio [ACR] ≥30 mg/g or ≥3 mg/mmol or both). Routine treatment, as administered by the treating physician, was continued without any study specific intervention. Patients′ data pertaining to demographic characteristics, medical history, current medication and physical examination were recorded. The blood/plasma and urine samples, were collected for estimation of hemoglobin A1c, microalbuminuria, serum creatinine, urine creatinine, and routine urine analysis. ACR was calculated from urine creatinine and albumin while GFR was estimated by using a modification of diet in the renal disease equation. Results: Study recruited 1500 patients from 18 centers across India. The study population included 840 (56.05%) males. Mean age, body mass index and systolic blood pressure were 55.1 years, 27.4 kg/m 2 and 134.5 mmHg respectively. The mean duration of diabetes was 102.2 months. History of co-morbid diseases such as dyslipidemia, hypertension, microvascular complications and macrovascular complications was present in 657 (43.8%), 655 (43.7%), 268 (17.9%) and 104 (6.93%), respectively. This interim analysis revealed that about 46% of the T2DM patients had CKD (urinary albumin creatinine ratio (UACR) ≥30 mg/g and/or estimated GFR [eGFR] <60 mL/min/1.73 m 2 ). The renal dysfunction as per eGFR criteria (<60 mL/min/1.73 m 2 ) was reported in about 23% while as per UACR criteria (≥30 mg/g) it was reported in about 35% patients. Conclusion: This interim analysis results suggests that over 40% of T2DM patients have CKD. Despite this high number of T2DM patients with CKD, eGFR analysis shows there are almost 80% of T2DM patients still have reasonably good renal function (eGFR above 60 ml/min), which ensures less restrictions in selecting oral anti-diabetic drugs. Full study results from Start-India study will provide detail insights into the occurrence of CKD in patients with T2DM in India. |
topic |
Albumin creatinine ratio chronic kidney disease diabetes mellitus glomerular filtration rate renal dysfunction |
url |
http://www.ijem.in/article.asp?issn=2230-8210;year=2015;volume=19;issue=4;spage=520;epage=523;aulast=Prasannakumar |
work_keys_str_mv |
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