|Year : 2022 | Volume
| Issue : 4 | Page : 243-246
Community assessment of incidence of quantitative microalbuminuria at the time of first diagnosis of type 2 diabetes mellitus – kumbakonam urban–rural epidemiological study – kures 9
MR Suchitra1, Monica Anand2, Balachandar Saravanan3, S Parthasarathy4
1 Department of Chemistry and Biosciences, SASTRA (SRC), Thanjavur, Kumbakonam, Tamil Nadu, India
2 Department of Internal and General Medicine, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth, Puducherry, India
3 Department of Anaesthesiology, JIPMER, Puducherry, India
4 Department of Anaesthesiology, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth, Puducherry, India
|Date of Submission||12-Nov-2022|
|Date of Decision||08-Dec-2022|
|Date of Acceptance||09-Dec-2022|
|Date of Web Publication||16-Dec-2022|
Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth, Puducherry
Source of Support: None, Conflict of Interest: None
Background: Diabetic nephropathy (DN) is a condition defined by persistent albuminuria and progressive loss of kidney function, with the term implying the occurrence of a typical described pattern of glomerular disorder. The early marker of the disease is detecting microalbuminuria in the urine. Methods: The patients who consented for the sampling was considered when they were diagnosed with diabetes mellitus (DM) for the first time. The first hundred adult patients who consented to participate were included. Established methods were used to estimate quantitative microalbumin in the urine from the first sample of the morning. All the positive reports were counter-checked. The initiation of drugs was left to the physician's choice. Any other events were recorded. On arrival, random blood sugar and blood pressures were recorded. Descriptive analyses and Pearson correlation analyses were used. Results: A total of 101 patients were analyzed. There were 58 males and 43 females. The microalbuminuria was positive in 44.6% of newly diagnosed cases. There was no relationship between the random sugar values, age, or sex with the incidence of microalbuminuria. The mean ages of both the positive and negative cases were similar. Conclusion: There was a high incidence of microalbuminuria in our study among newly diagnosed DM. With such a high incidence of early renal damage on diagnosis, we suggest that the initial management should switch from other drugs to inhibitors of the sodium-glucose cotransporter 2 (SGLT2). We theorize that the high incidence may be due to a delayed diagnosis of diabetes in our area and a poor control of the disease. With such a high incidence of early renal damage on diagnosis, we suggest that the initial management should switch from other drugs to inhibitors of the SGLT2. This is the first such study on the incidence of early nephropathy on first diagnosis of DM.
Keywords: Diabetes mellitus, diagnosis, kidney, microalbumin
|How to cite this article:|
Suchitra M R, Anand M, Saravanan B, Parthasarathy S. Community assessment of incidence of quantitative microalbuminuria at the time of first diagnosis of type 2 diabetes mellitus – kumbakonam urban–rural epidemiological study – kures 9. Asian J Pharm Res Health Care 2022;14:243-6
|How to cite this URL:|
Suchitra M R, Anand M, Saravanan B, Parthasarathy S. Community assessment of incidence of quantitative microalbuminuria at the time of first diagnosis of type 2 diabetes mellitus – kumbakonam urban–rural epidemiological study – kures 9. Asian J Pharm Res Health Care [serial online] 2022 [cited 2023 Feb 6];14:243-6. Available from: http://www.ajprhc.com/text.asp?2022/14/4/243/363937
| Introduction|| |
Diabetes is one of the most serious global health crises of the 21st century, placing it above in the top ten causes of death alongside cardiovascular disease, respiratory disease, and cancer. According to the World Health Organization, noncommunicable diseases contributed to 74% of global deaths in 2019, with diabetes accounting for 1.6 million deaths, making it the ninth most common cause of death worldwide., Diabetic nephropathy (DN) is a condition defined by persistent albuminuria and progressive loss of kidney function, with the term implying the occurrence of a typical described pattern of glomerular disorder. Diabetes is said to affect the kidneys in 20%–50% of those who have the disease. Modifiable risk factors, such as alcohol and tobacco use, physical exercise, stress, body mass index, hemoglobin A1C (HbA1c) level, hypertension (blood pressure [BP]), blood lipid profile, GFR, and albuminuria, must be managed to avoid the development of and progression of chronic kidney disease (CKD) in diabetes. Diabetic renal disease is infrequent if diabetes has been present for a little <10 years. The highest annual incidence rates of 3% are seen 10–20 years ever since the onset of diabetes, after which the proportion of nephropathy begins to decline. It is prudent to state that a diabetic patient who has been diabetic for 20–25 years with no clinical signs of diabetic kidney disease (DKD) has a low risk of developing such a problem. In clinical settings, DKD is diagnosed by assessing kidney function, typically by determining the estimated glomerular filtration rate (eGFR), and kidney damage can be assessed typically by checking urinary albumin-to-creatinine ratio, urine albumin (mg/L)/urine creatinine (mmol/L) in random spot samples of urine. Early diagnosis of microalbuminuria and prevention of progression to CKD remains a critical step in the epidemiology of DN. Hence, in this study, we aimed to detect the urinary microalbumin level at the time of diagnosis of the disease and establish the incidence for the same.
| Materials and Methods|| |
The study was done in a center in South India between December 2021 and August 2022. After an ethical committee approval and informed consent from patients (ethics number IRBSTH/103/2021), the study was conducted in accordance with the declaration of Helsinki. The risk is a minimal risk according to ICMR guidelines 2017.
Inclusion and exclusion criteria
A consecutive sampling technique was used in consented patients with the first diagnosis of type 2 diabetes mellitus (DM) were included in the study. Patients with any symptoms of urinary infection, any other comorbid illness or any drugs which can alter the tests were excluded from the study. Any history suggestive of earlier diagnosis and discontinuation of drugs were excluded. The patients with urinary infection were also excluded from the study.
Diagnosis of diabetes mellitus
Patients should have a fasting plasma venous glucose of >126 mg/dl (fasting means a no-calorie intake of 8 h or a post-prandial plasma venous glucose of >200 mg/dl. As the patients are coming for the first time, the diagnosis based on HbA1C was not considered. A random sugar of more than 200 mg/dl with symptoms other than urinary symptoms peculiar to DM was also considered for the diagnosis.
The basic variables such as blood sugar values, BP, age, and sex at the time of presentation were noted. All patients were instructed to get a quantitative assay of random urine microalbumin by a validated microalbumin analyzer. An estimate of 30–300 mcg in the morning specimen of urine was confirmed as microalbuminuria positive. All positive cases were checked again in around 30 min to confirm the diagnosis. Any change in more than 5% between the two levels was noted. The plan was to counsel all positive cases with initiation of sartans and an advice for a rigorous specialist follow-up.
Using Raosoft software 2004 by (Raosoft, Inc.. Seattle USA) for epidemiological studies, with a population of one lakh, alpha error of 0.05 and power of 80%, the sample size was estimated to be 96. To avoid dropouts, we did take 101 samples. All data were collected in an excel sheet and transferred to IBM SPSS Statistics for Windows, Version 28.0. (Armonk, NY: IBM Corp) and analyzed A descriptive analysis was done for the incidence and Pearson correlation was done for the influencing factors.
Risk of bias
The history regarding the first diagnosis of Type 2 DM was taken from the patient and from the attendants. This was done with the utmost attention. Still the patient need not reveal an earlier diagnosis and left uncared.
| Results|| |
All the 101 patients complied with the instructions and completed the study. In none of the positive patients, the values on two occasions varied more than 5%. They were positive on both occasions. There were only two hypertensives in this study before diagnosis of diabetes whose microalbumin was negative. There were no dropouts. The microalbumin levels and the number of patients are depicted in [Table 1].
This shows a very high incidence of microalbuminuria at the time of diagnosis. Regarding the gender variation, the results are detailed in [Table 2].
There is no correlation in the incidence of microalbumuria with age, systolic, and diastolic BPs [Table 3].
There is neither a correlation between systolic and diastolic BPs [Table 4].
Considering the correlation analyses, there was no significance between the incidence of microalbuminuria and age, systolic or diastolic BPs. There was no correlation between the incidence of microalbumuria and the blood sugar values.
- Correlation values and P value
- Age and microalbuminuria −0.761
- Systolic BP and microalbuminuria −0.245
- Diastolic BP and microalbuminuria −0.9
- The Pearson correlation coefficient was not significant with the described variables.
| Discussion|| |
Our study has revealed a very high incidence of microalbuminuria. Selby and Taal have discussed in the review the need for Albumin creatinine ratio (ACR) testing and confirm the diagnosis of early kidney disease. It is pertinent to consider biological variance in ACR values while monitoring sequential changes or response to therapy, and vigilance should be exercised when trying to interpret differences between two measures. Examining sequential trends is a more dependable method. In our study, we have studied only spot urine sample and the quantitative estimation of microalbumin. Yet in positive cases, we have repeated the test with different and sample and arrived at a value. Microalbuminuria (30-300 mg/g) is largely viewed as a forerunner of DN, both suggesting early risk and serving as a target for intervention. However, in certain cases, microalbuminuria can go into remission, either naturally or as a result of therapy. The above concept of Gaede et al. was applied in our study with a possible remission with early drug initiation. Hussain et al. in their exhaustive review have found out that a cross-sectional study from a risk evaluation action plan in China discovered 38.8% prevalence of CKD in 15856 diabetic patients. A population-based study found that DKD was present in 2.9% of Chinese rural dwellers. One more group discovered a 34.4% occurrence of DKD in India in a study. A multi-center study in India found that the composite presence of diabetic-CKD was around 62.3%. All these studies have concentrated more on prevalence rather than incidence at the time of diagnosis. Ours is the rare study which discusses incidence on diagnosis of type 2 DM. Sana et al. have described the prevalence of microalbuminuria as around 25% in patients with diabetes of a mean duration of 6.2 years. Even though the prevalence is high in their studies, its 6 years after diagnosis. We propose a few reasons for the high incidence. The first one is the time delay in the diagnosis of DM. The international diabetes federation has detected a 40% incidence of undiagnosed diabetes in the community. This varies with country to country and region to region. This undiagnosed diabetes and the ongoing mild renal damage could have resulted in such incidence of early nephropathy in our cases. In our earlier study, we have found out that the control of type 2 DM is poor even in known cases. In our area with random HbA1c of 8.91, this fact along with other combined factor of late diagnosis may be the possible reasons for high values in our study. The other reason is the dependability of testing. We have validated the instrument before initiation of the study. The second confirmative test was unique for us. Yet we did not give a time delay of 6 h for the tests for want of compliance. The ACR testing could have been done in these cases and confirmed which was not done in our work. In their study by Ahmed et al., the prevalence of microalbuminuria was 31.56%, strongly linked with high BP, and poor glycemic control, and in it was strongly linked with high BP, poor glycemic control, as well as other diabetic complications such as neuropathy and retinopathy. Although it is consistent with other parts of the world, the high prevalence of diabetes in our country predicts a substantial number of people with renal and other diabetic complications. In short time, immediate treatment to prevent any future mayhem is needed. The most important limitation in our study is that its single centered with a sample size of 101. The findings cannot be totally extrapolated immediately to a large country with a population in billions. We cared for the diagnosis at the first visit than the number. We did not test for HbA1C at the time of visit which is our limitation. The significant other finding in our case is 33 patients out of 101 were below the age of 45 years. This alerts us the possibility of more severe surveillance at the community level in middle aged adults. Another significant factor is there is not much difference between males and females (58 vs. 43) unlike in the past decade. Nespoux and Vallon have found the usefulness of gliflozins in renoprotection in patients type 2 diabetes. With such a high incidence of early renal damage on diagnosis, the initial management should switch from other drugs to inhibitors of the sodium-glucose cotransporter 2 (SGLT2). The plan in our cases was to follow up the cases with renal function tests and ultrasound abdomen every 6 months and an expert opinion if needed. All the positive patients were suggested sartans according to the BP the dosage was adjusted. They were advised eGFR estimations at regular intervals. There is no literature on the percentage of patients ignoring a mild disorder of diabetes and trying to get medical attention after 1 or 2 years when they become symptomatic.
| Conclusion|| |
In a single-center prospective epidemiological study, the incidence of spot microalbuminuria is around 44.6% among newly diagnosed type 2 DM. There was no correlation between age, sex, initial blood sugar, and BP on the incidence. We had two cases of hypertension before recognition of DM but both were negative for urinary microalbumin. With such a high incidence of early renal damage on diagnosis, we propose that the initial management should switch from other drugs to inhibitors of the SGLT2. We theorize that a delayed diagnosis and a possible lack of adequate diabetic control in our area may be the possible causes of such high incidence.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]