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Table of Contents
ORIGINAL ARTICLE
Year : 2021  |  Volume : 9  |  Issue : 3  |  Page : 159-166

Assessment of symptoms and complications in treatment naive newly diagnosed type 2 diabetes mellitus and their correlation with glycemic parameters: A cross-sectional study from kalyana Karnataka


1 Department of Medicine, M R Medical College, Kalaburagi, Karnataka, India
2 Department of Pediatrics, M R Medical College, Kalaburagi, Karnataka, India

Date of Submission05-Dec-2020
Date of Decision13-Jan-2021
Date of Acceptance01-Mar-2021
Date of Web Publication16-Jul-2021

Correspondence Address:
Dr. Swaraj Waddankeri
MD, Associate Professor, Department of Medicine, M R Medical College and Chief Consultant, Karnataka - 585 105
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ajim.ajim_97_20

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  Abstract 


Background and Objectives: The Assessment of symptoms in newly diagnosed type 2 diabetes mellitus (T2DM) and determine its correlation with glycemic parameters such as General random blood sugar (GRBS) Fasting blood sugar (FBS), Post prandial blood sugar (PPBS), and Glycated hemoglobin (HbA1c) at diagnosis. Methodology: Cross-sectional, observational, single-arm study of 73 consecutive cases of treatment naïve, newly diagnosed T2DM with a baseline HbA1c >9. Hyperglycemic symptoms and complications were assessed at diagnosis and evaluated for their association with glycemic parameters (FBS, PPBS, and HbA1c). Results: Nocturia and weight loss were positively correlated (P < 0.05) to FBS, PPBS, and HbA1c. The most frequently observed symptoms in patients with complication were weight loss (16/18, 88.9%), followed by nocturia (14/18, 77.8%), polyuria (12/18, 66.6%), and balanitis (10/18, 55.5%). Furthermore, nocturia was associated with higher GRBS and polyuria/polyphagia with higher HbA1c at diagnosis. The mean General Random Blood Sugar (GRBS) was 335.4 mg/dl. The mean FBS and PPBS were 272 mg/dl and 397.1 mg/dl, respectively. The mean of HbA1c at diagnosis was 12.6%. Conclusions: Hypertension was the most common comorbidity. Chronic kidney disease and nonproliferative diabetic retinopathy were the commonly observed complications. In newly diagnosed T2DM patients, nocturia, polyuria, and weight loss were the most common symptoms associated with higher glycemic levels at presentation. Hypertension with higher creatinine at diagnosis is one of the ominous signs of harboring one or more underlying complication.

Keywords: Microvascular complications and glycemic control, new onset type 2 diabetes mellitus, prevalence, symptoms


How to cite this article:
Waddankeri S, Meenakshi S W, Mangshetty B. Assessment of symptoms and complications in treatment naive newly diagnosed type 2 diabetes mellitus and their correlation with glycemic parameters: A cross-sectional study from kalyana Karnataka. APIK J Int Med 2021;9:159-66

How to cite this URL:
Waddankeri S, Meenakshi S W, Mangshetty B. Assessment of symptoms and complications in treatment naive newly diagnosed type 2 diabetes mellitus and their correlation with glycemic parameters: A cross-sectional study from kalyana Karnataka. APIK J Int Med [serial online] 2021 [cited 2021 Sep 24];9:159-66. Available from: https://www.ajim.in/text.asp?2021/9/3/159/321667




  Introduction Top


Diabetes mellitus (DM) is a potentially disabling chronic metabolic disorder with multiple complications. It is characterized by defects in insulin secretion and action.[1] The incidence of type 2 DM (T2DM) has risen rapidly over the recent years and the expanding burden of diabetes and its complications puts burden on the public in general and the health-care facilities of the nation at large.[2] T2DM is the most prevailing form of diabetes assimilating 90% of the diabetic population. Glycemic control in diabetes is the cornerstone in reducing morbidity and mortality.[3] Accomplishing glycemic control significantly reduces the vascular complications of diabetes.[4] Glycosylated hemoglobin (HbA1c), fasting blood glucose (FBS), and postprandial blood glucose (PPBS) are the measurements which are routinely used for the assessment of glycemic control in people with diabetes.[5] Clinical manifestations commonly seen in poor glycemic control are nocturia, polyuria, genital itching, and weight loss.[6] Other symptoms that may suggest hyperglycemia include blurred vision, lower extremity paraesthesia's, balanitis in men, or vulvovaginitis in females.[1]

Globally, a rough estimate points to 463 million people with diabetes representing a prevalence rate of 9.3% of the total population. India was home to around 77 million people with diabetes in 2019 and this number is anticipated to rise to 101 million by 2030.[3] Another worrying aspect is close to 50% of the people with diabetes are unaware of their diagnosis due to the indolent nature of the disease. People with diabetes run the risk of being in a latent, asymptomatic period which often remains undiagnosed for several years.[3] Owing to a delay in diagnosis by an average of 3–5 years which leads to a significant proportion of people with complications at the time of diagnosis, which is often detected on routine screening.[7] Among patients with T2DM in the United Kingdom Prospective Diabetes Study (UKPDS), 25% had retinopathy; 9%, neuropathy; and 8%, nephropathy at the time of diagnosis.[8] Therefore, several studies have led efforts to increase awareness of early diagnosis in the treatment of T2DM.[9] As of today, there are very few studies on the prevalence, symptoms in new-onset diabetes, and its association with HbA1c levels.[10],[11]

The present study is intended to determine the multiple symptoms of newly diagnosed T2DM and its correlation with glycemic parameters based on the presence and absence of vascular complications at the time of diagnosis.

Objectives of the study

  1. Assessment of clinical and glycemic parameters in treatment naïve newly diagnosed type 2 diabetes with HbA1c >9%
  2. To correlate the symptoms of diabetes with GRBS, FBS, PPBS, and HbA1c
  3. To assess the demographics and clinical characteristics of the patients based on the presence and absence of vascular complications at the time of presentation.



  Methodology Top


This was a prospective, cross-sectional, single-arm observational study from Karnataka. We determined the clinical and glycemic parameters in treatment naïve newly diagnosed type 2 diabetes with HbA1c >9% at diagnosis. Institutional clearance from the ethics board was obtained as per the standard protocol.

Inclusion criteria

The study population was the consecutive outpatients presenting to a general tertiary care hospital over a period of 8 months between January 2019 and August 2019. The study comprised a total of 73 cases of treatment naïve patients with new-onset type 2 diabetes between the age group of 20 and 70 years of either gender with HbA1c >9% at the time of diagnosis.

Exclusion criteria

  • Type 1 diabetes/pancreatic diabetes/fibrocalculous pancreatic diabetes
  • Age younger than 20 years or older than 70 years
  • Patients with emergencies-acute myocardial infarction/unstable angina/non-ST-elevation myocardial infarction/stroke/pancreatitis/diabetic ketoacidosis/hyperosmolar nonketotic coma/surgical emergencies
  • Patients on chronic steroid medications for malignancy/asthma/rheumatoid arthritis
  • HbA1c <9% at diagnosis.


Clinical data

All the history and basic clinical examination were done by the same observer. A preset, pro forma was used to maintain the uniformity in the history collection and physical examination. The data for this cross-sectional study contained patients' age, gender, family history of diabetes, history of comorbid illness, and symptoms at the time of presentation. For each patient, we screened for the presence or absence of diabetes complications. Height was measured from a wall-mounted and fixed stadiometer, nearest to 0.1 cm was taken as the height of the subject with the subjects' head in the Frankfurts plane. Weight was measured with an electronic weighing scale by Omron. Reading to the nearest of 0.1 kg was recorded as the weight of the subject. Body mass index (BMI) was calculated as weight in kg divided by height in meters squared.

Blood pressure was recorded to the nearest 2 mmHg in the sitting position in the right arm with a mercury sphygmomanometer. Two readings were taken 5 min apart, and the mean of the two was calculated. Variations in blood pressure measurements were minimized by (1) ensuring 10 min rest before the recording, (2) using appropriate adult cuffs for lean and overweight individuals, and (3) having the same observer recording blood pressure. Fundoscopy was performed by an ophthalmologist after dilatation of pupils with tropicamide, the ophthalmologist was blinded to the study.

All patients were examined, with special attention for the presence or absence of markers of insulin resistance skin tags and acanthosis nigricans, goitre – graded according to WHO criteria along with examination of peripheral pulses.

Biochemical

Glucometer RBS was measured irrespective of the meal status using the commercially available Alere Glucometer. FBS and PPBS (glucose oxidase-peroxidase method) were measured on a Autoanalyzer (Turbo-Chem 100 by CPC diagnostics). HbA1c was estimated by high-pressure liquid chromatography using the Variant machine (Bio Rad D-10). Creatinine was measured in the commercially available Autoanalyzer Turbo-Chem 100.

Statistical analysis

Statistical analysis was done by estimating the symptoms in treatment naïve newly diagnosed type 2 diabetes and correlating with glucose parameters. All the statistical analysis were done using the software STATA 13.0 (StataCorp LP, USA). Descriptive statistics such as percentages and frequencies were used in the data summaries. Relationship between two variables was done using Pearson correlation test. The correlation coefficient value ranges from −1 to +1, the negative value represents that the parameters are inversely proportional to each other, and the positive value represents that the parameters are directly proportional to each other. The extent to which this correlation coefficient can show a significance was given in terms of P value. P < 0.05 was taken as statistically significant and the data were represented in the form of tables and graphs.


  Results Top


Over the 8-month study period (January 2019 to August 2019), a total of 73 treatment naïve newly diagnosed T2DM patients were included. Demographics and clinical characteristics of subjects were categorized based on the presence or absence of complications at the time of diagnosis. Out of total of 73 subjects, 18 subjects (24.7%) had complication and 55 subjects (75.3%) did not have any complications. [Table 1] describes the summary statistics of complications. The most frequently observed complications in our study was hypertension (21.82%) followed by chronic kidney disease (CKD) (10.9%) and nonproliferative diabetic retinopathy (9.09%), respectively.
Table 1: Summary statistics of Complications Observed in Subjects

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Demographics and clinical characteristics of the subjects with complications

We had a total of 18 cases associated with various complications, of which ten (55.56%) were males with a mean age of the patients was about 45 years. [Table 2] presents the demographic and anthropometric characteristics of the patients with complications. The mean BMI was noticed to be 25 kg/m2.
Table 2: Demographics and anthropometry in subjects with complications

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The mean systolic and diastolic blood pressure was found to be 136.67 mmHg and 82.78 mmHg, respectively. [Table 3] outlines the summary of the statistics of glycemic parameters in subjects with complications. The average of glycemic parameters including GRBS, FBS, and PPBS was reported to be 335.4, 272.3 mg/dl, and 397.1 mg/dl, respectively. The mean of HbA1c at diagnosis was 12.6% ranging from 9.4% to 19.5% and the mean creatinine was found to be 1.53 mg/dl.
Table 3: Summary statistics of glycemic parameters in subjects with complications

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As shown in [Table 4], the most observed symptoms in subjects with complications were weight loss (16/18, 88.9%) followed by nocturia (14/18, 77.8%), polyuria (12/18, 66.6%), balanitis (10/18, 55.5%), paraesthesia (9/18, 50%), giddiness (6/18, 33.4%), and retinopathy (1/18, 5.6%).Out of total 18 patients with complications, varying grades of acanthosis nigricans was observed in 13 patients (72.2%) and skin tags were observed in six patients (33.3%).
Table 4: Summary statistics of symptoms and conditions in subjects with complications

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Demographics and clinical characteristics of the subjects without complications

Among 73 patients, 55 patients did not have any complications at the time of presentation. Out of 55 patients, 37 (67.27%) were males with a mean age of the patients was about 44.05 years. The mean BMI was observed to be 25.43 kg/m2. [Table 5] presents the demographic characteristics of the patients without complications.
Table 5: Summary of patients Demographics without complications

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The mean systolic and diastolic blood pressure was found to be 128.6 mmHg and 82.6 mmHg, respectively. [Table 6] describes the summary statistics of vital signs and diabetes-related parameters in subjects without complications. The average of glycemic parameters including GRBS, FBS, and PPBS was noticed to be 300.7 mg/dl, 239.48 mg/dl, and 371.83 mg/dl, respectively. The mean of HbA1c at diagnosis was 11.7% ranging from 9.1% to 16.9% and the mean creatinine was found to be 0.9 mg/dl.
Table 6: Summary statistics of Vital signs and Diabetes Related Parameters in subjects without complications

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As shown in [Table 7], the most commonly observed symptoms in subjects without complications were weight loss (41/55, 74.5%) followed by polyuria (40/55, 72.7%), nocturia (40/55, 72.7%), paraesthesia (23/55, 41.8%), balanitis (20/55, 36.3%), giddiness (11/55, 20%), decreased vision/retinopathy (7/55, 12.7%), and febrile illness (4/55, 7.27%), respectively. Family history was noticed in 26 patients (47.28%). Out of 55 subjects without complications, acanthosis nigricans was present in 27 patients (49%) and skin tags were observed in 13 patients (23.6%).
Table 7: Summary statistics of Symptoms and Conditions Observed in Subjects without complications

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Correlation of symptoms of diabetes with glycemic parameters at diagnosis

We evaluated the correlation between glycemic parameters and multiple symptoms of treatment naïve newly diagnosed T2DM patients. [Table 8] presents the correlation between glycemic parameters and multiple symptoms. Nocturia and weight loss were positively correlated (P < 0.05) to FBS, PPBS, and HbA1c. Furthermore, only nocturia was associated with GRBS and polyuria/polyphagia with HbA1c. Out of eight commonly observed symptoms at diagnosis, only three symptoms were frequently associated with the higher glycemic levels.
Table 8: Correlation Coefficients of Glycemic parameters with Multiple symptoms

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As seen in the [Table 9], although most of the parameters showed no significant correlation between complication versus no complications group, systolic blood pressure, fasting blood sugars, HbA1c showed near significant correlation. Creatinine was statistically associated with complications.
Table 9: Summary of Comparison of key Clinical and Glycemic variables in the Complication Vs No Complication Group

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  Discussion Top


Significant proportion of individuals with T2DM remains undiagnosed and untreated before the onset of diabetes complications.[12] The study data from the fourth National Family Health Survey a population-based household survey conducted in 2015 and 2016 among Indians aged 15–49 years which contained the blood glucose measurement of 730,000 adults from 29 states and seven union territories revealed that almost half (47.5%) of them unaware of their diabetic condition and have diagnosis of micro and/or macrovascular complications already present at time of diagnosis.[13] These estimates confirm that lack of detection of diabetes persists across all regions and income groups. Therefore, we aimed to estimate the symptoms and complications of treatment naïve newly diagnosed type 2 diabetes along with determining its correlation with glycemic parameters.

In the present study, demographics and clinical characteristics of subjects were categorized based on the presence and absence of complications at the time of diagnosis. Out of total of 73 subjects, 18 subjects (24.7%) were presented with complication which was far lesser to a study conducted by Mitra et al.,[14] which observed that the incidence of complications at the time of presentation was 51% in treatment naïve newly diagnosed T2DM patients. The most frequently observed comorbidity in our study was hypertension (21.82%) followed by microvascular complication of CKD (10.9%) and nonproliferative diabetic retinopathy (9.09%), respectively. UKPDS on T2DM patients, reported that about 25% had retinopathy; 9%, neuropathy; and 8%, nephropathy at the time of diagnosis.[8]

In a total of 18 cases with complications, ten (55.56%) were males with a mean age of 45 years. The average of glycemic parameters including GRBS, FBS, and PPBS was 335.4 mg/dl, 272.3 mg/dl, and 397.1 mg/dl, respectively. The mean of HbA1c at diagnosis was 12.6% ranging from 9.4% to 19.5%. The most commonly observed symptoms in subjects with complications were weight loss (16/18, 88.9%) followed by nocturia (14/18, 77.8%), polyuria (12/18, 66.6%), balanitis (10/18, 55.5%), paraesthesia (9/18, 50%), giddiness (6/18, 33.4%), and decreased vision/retinopathy (1/18, 5.6%), respectively. Out of total 18 cases with complication, acanthosis nigricans was observed in 13 patients (72.2%) and skin tags were observed in six patients (33.3%).

Out of 55 cases with no complications, 37 (67.27%) were males with a mean age of 44.05 years. The average of glycemic parameters including GRBS, FBS, and PPBS was 300.7 mg/dl, 239.48 mg/dl and 371.83 mg/dl, respectively. The mean of HbA1c at diagnosis was 11.7%. The most frequently observed symptoms in subjects without complications were weight loss (41/55, 74.5%) followed by polyuria (40/55, 72.7%), nocturia (40/55, 72.7%), paraesthesia (23/55, 41.8%), balanitis (20/55, 36.3%), giddiness (11/55, 20%), retinopathy (7/55, 12.7%), and febrile illness (4/55, 7.27%), respectively. Compared to our findings, an epidemiological population-based study of 1137 Danish patients with newly diagnosed type 2 diabetes by general practitioners have noticed that frequent urination, weight loss, abnormal thirst, genital itching, stomatitis, visual disturbances, fatigue, confusion, and balanitis were common in newly diagnosed type 2 diabetic patients, but they didn't focused on demographics and clinical characteristics of patients based on the presence and absence of complication at diagnosis.[15] A similar study in the Dutch population between 1999 and 2001 found that approximately 75% of newly diagnosed diabetic patients had one or more symptoms typical of diabetes,[16] implying that proportion of symptomatic patients has not changed within the last decade despite changes in diagnostic measures and increasing focus on the disease.

Correlation of symptoms of diabetes with glycemic parameters at diagnosis

In the present study, nocturia and weight loss showed positive correlation (P < 0.05) with FBS, PPBS, and HbA1c levels. Furthermore, only the lone symptom nocturia was associated with higher GRBS and polyuria/polyphagia associated with higher HbA1c. Out of eight commonly observed symptoms at diagnosis, only three symptoms were frequently associated with the glycemic levels. Our findings were equivalent to the study conducted by Bulpitt et al.[17] in determining the association of symptoms of T2DM with severity of disease, obesity, and blood pressure. The study suggests that dry mouth (P < 0.001), thirst (P < 0.01), and pain abdomen (P = 0.02) were positively related to FBS independent of sex and age and only one of these symptoms, i.e., dry mouth was statistically related to HbA1c.[17] An epidemiological population-based study reported that majority of symptoms including abnormal thirst, frequent urination, weight loss, genital itching, stomatitis, and visual disturbances were associated with both FBS and HbA1c.[15] Based on these studies, it is confirmed that most of the symptoms were associated to glycemic levels at the time of type 2 diabetes diagnosis.

The strengths of the study – prospective study, enter the unchartered territory of correlating hyperglycemia with hyperglycemic symptoms and vascular complications. The drawbacks of the study – small sample size, did not assess the impact of dyslipidemia and hypertension on the vascular complications, which are frequently associated with diabetes. We did not assess microalbuminuria as a marker for CKD, as microalbuminuria requires a follow-up repeat assessment to establish a diagnosis hyperglycemia as an etiology for CKD.


  Conclusions Top


This cross-sectional and observational study in newly diagnosed type 2 diabetes evaluated the correlation between symptoms and glycemic parameters at diagnosis and their correlation with vascular complications. Out of eight commonly observed symptoms at diagnosis only three symptoms nocturia, weight loss, and polyuria were associated with higher glycemic levels at presentation.

We concluded that about 24.7% of patients presented with complications at the time of diagnosis. Hypertension was the most common associated comorbidity whereas complications such as CKD and nonproliferative diabetic retinopathy were the commonly observed microvascular complications in our study. Although both patient with and without complications present with similar set of symptoms at diagnosis, clinical screening for target organ damage – retinopathy, neuropathy, and nephropathy is essential in newly diagnosed people with diabetes. Hypertension with higher creatinine at diagnosis is one of the ominous signs of harboring one or more underlying complication.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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King P, Peacock I, Donnelly R. The UK prospective diabetes study (UKPDS): Clinical and therapeutic implications for type 2 diabetes. Br J Clin Pharmacol 1999;48:643-8.  Back to cited text no. 8
    
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Prenissl J, Jaacks LM, Mohan V, Manne-Goehler J, Davies JI, Awasthi A, et al. Variation in health system performance for managing diabetes among states in India: A cross-sectional study of individuals aged 15 to 49 years. BMC Med 2019;17:92.  Back to cited text no. 13
    
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Mitra V, Ram T, Neusha D, Sanghani S, Anusha Y, Tanv N. Incidence of microvascular complications in newly diagnosed diabetes mellitus. J Evid Based Med Healthc 2019;6:2760-4.  Back to cited text no. 14
    
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Drivsholm T, de Fine Olivarius N, Nielsen AB, Siersma V. Symptoms, signs and complications in newly diagnosed type 2 diabetic patients, and their relationship to glycaemia, blood pressure and weight. Diabetologia 2005;48:210-4.  Back to cited text no. 15
    
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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9]



 

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