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MAGNITUDE OF AUTONOMIC NEUROPATHY IN TYPE 2 DIABETES MELLITUS PATIENTS OF MORE THAN 5 YEARS DURATION IN A TERTIARY CARE HOSPITAL OF ODISHA.

BACKGROUND

Diabetes mellitus (DM) is a heterogeneous chronic metabolic disorder principally characterised by persistent hyperglycaemia resulting from defects in insulin secretion, decreased glucose utilization, and increased glucose production. It also involves abnormality in carbohydrate, fat and protein metabolism. [1,2,3]

Diabetes mellitus is classified on the basis of the pathogenic process that leads to hyperglycaemia. [1,2]

1. Type 1 DM.

2. Type 2 DM.

3. Other specific types of DM.

4. Gestational DM.

The chronic hyperglycaemia of diabetes is associated with long term damage, dysfunction, and failure of different organs, especially the eyes, kidneys, nerves, heart and blood vessels. Most of the mortality in diabetic population is due to its complication. [2]

Diabetic autonomic neuropathy (DAN) is a serious and common complication of diabetes that is most often ignored by most of the clinicians. [2]

Diabetic autonomic neuropathy (DAN) is among the least recognized and understood complication of diabetes de-spite its significant negative impact on survival and qual-ity of life in people with diabetes. [4] DAN goes completely unrecognised by patient and physician because of its insidious onset and protean multiple organ involvement. DAN can involve multiple systems including cardiovascular, gastrointestinal, genito-urinary, sudomotor, metabolic systems, pupillary dysfunction. [4,5]

Cardiac autonomic neuropathy (CAN) is the most studied and clinically important form of DAN because of its life-threatening consequences and the availability of direct noninvasive tests of cardiovascular autonomic functions. CAN results from damage to the autonomic nerve fibers that innervate the heart and blood vessels and results in abnormalities in heart rate control and vascular dynamics.

The present study has been undertaken to determine the prevalence of autonomic neuropathy in diabetes mellitus patients of more than 5 years duration and correlation of autonomic neuropathy with references to age, sex, and duration of diabetes. This study will through light on the importance of assessment of autonomic neuropathy during the course of type 2 diabetes mellitus, so that necessary therapeutic measures may be initiated early to decrease the morbidity and mortality associated with autonomic neuropathy.

Aims and Objective

* Magnitude of autonomic neuropathy in type 2 diabetes mellitus patient of more than five-year duration

* Correlation of diabetic autonomic neuropathy with age, sex, body mass index and duration of diabetes.

MATERIALS AND METHODS

Study Design

Cross Sectional Study.

Sampling Technique

Convenient sampling.

The present study is a tertiary care hospital based cross sectional study.

This study includes type 2 diabetes mellitus patients who attain OPD or

Emergency or admit in IPD at SCBMCH, Cuttack, Odisha. All the patients from either sex who meet the following inclusion criteria are consider for inclusion in this study.

Sample size was taken based on the convenience of the study.

Inclusion Criteria

1. Age above 30 years.

2. Duration of type 2 diabetes mellitus -5 years or more.

All the patients from either sex who meet the following exclusion criteria are exclude from the study.

Exclusion Criteria

1. Patients with hypotension, congestive cardiac failure, ischaemic heart disease, hyperthyroidism, chronic renal failure, multiple system atrophy, Addison's disease.

2. Patients on medications such as vasodilators, diuretics, antiarrhythmic, beta blockers, alpha-agonist or alpha blocker.

3. Patient presented as fever due to any cause.

An informed consent for inclusion in this study will be obtained from all the patients. Each patient will undergo detailed history, through clinical examination, and biochemical tests as required. History regarding patient biodata, present illness, past illness, personal history, family history will be noted. Clinical examination including general examination and systemic examination will be performed.

All patients will be explained about the different manoeuvres like standing, hand grip and squeeze of ball. All recruited patients will be tested for--

1. Heart Rate--A resting heart rate of more than 100 beats per minute considered abnormal

2. Orthostatic Hypotension--Blood pressure will be first measured in right arm supine position by using the sphygmomanometer and then instruct the patient to stand up. Again, blood pressure will be measured as the same way. A fall in systolic blood pressure > 20 mm Hg and/or in diastolic blood pressure >10 mm of Hg will be considered abnormal.

3. Hand Gripping Test-blood pressure of the patient will be first measured in supine position. Instruct to the patient to squeeze a small ball in his/her hand for about 5 min while lying in bed and again blood pressure will be measured by using sphygmomanometer. An increase in diastolic blood pressure < 15 mm hg is abnormal.

4. ECG Recording-QTc interval >= 440 ms will be considered as abnormal.

5. Exercise Intolerance--all patients undergo trade mill test to know the reduced response in heart rate and blood pressure during exercise. Those patients whose heart rate is not achieved target heart rate during exercise considered as abnormal and whose blood pressure is not achieved target during exercise considered as abnormal.

No Autonomic Neuropathy

All five tests normal

Mild Autonomic Neuropathy

One of the three heart rate tests abnormal

Moderate Autonomic Neuropathy

Two or more of the heart rate tests Abnormal or one of the blood pressure tests normal.

Severe Involvement

Two or more of the heart rate tests abnormal plus one of the blood pressure tests is normal or both blood pressure tests abnormal.

For gastrointestinal autonomic neuropathy, genitourinary autonomic neuropathy, hypoglycaemic unawareness, pupillary abnormality, sweating disturbances, only sign and symptoms will be noted as most part of the evaluation done only in research laboratory, requires specialized equipment. For erectile dysfunction patient will be asked questionnaire according to IIEF-5. (6)

Statistical Analysis

A master chart was prepared by collecting all the information in Microsoft office excel sheet. Then data are analysed by using SPSS software. P value was calculated by chi-square analysis and independent "t test".

Evaluation of Autonomic Neuropathy

A) Cardiovascular autonomic neuropathy

1. Resting tachycardia.

2. Orthostatic hypotension.

3. Abnormal Hand gripping test.

4. Qtc interval > 440 msec.

5. Exercise intolerance (by TMT).

B) Gastrointestinal autonomic neuropathy

1. Gastroparesis.

2. Constipation.

3. Diarrhoea.

4. Nocturnal diarrhoea alternating with constipation.

5. Faecal incontinence.

C) Genitourinary autonomic neuropathy

1. Sign and symptoms of neurogenic bladder.

2. Erectile dysfunction in male.

3. Retrograde ejaculation in male.

4. Sexual dysfunction in female.

D) Sudomotor

1. Anhidrosis.

2. Gustatory sweating.

3. Heat intolerance.

4. Dry skin.

E) Hypoglycaemic unawareness

F) Pupillary dysfunction

1. Impaired adaptation to ambient light.

2. Argyll Robertson pupil.

RESULTS

Out of 88 cases of type 2 diabetes mellitus 59 (67%) were male and 29(33%) are female. Mean age of male population is 57.5 [+ or -] 7.28 and for female is 53.4 [+ or -] 8.45.

Highest no. of patients was in the age group of 51-60 yrs. 38 patients (43.1%) were in this group, among them 25 (28.4%) were male and 13(14.7%) were female.

Lowest no. of patients was in the extreme age group i.e., 31-40 yrs., and 71-80 yrs. Both groups had 3 patients (3.04%).

Out of 59 male diabetic cases, 9 (10.2%) had no autonomic neuropathy, 15 (17.0%) had mild autonomic neuropathy, 22 (25%) had moderate autonomic neuropathy, 13 (14%) had severe autonomic neuropathy.

Out of 29 female diabetic cases, 6 (6.8%) had no autonomic neuropathy, 7 (7.9%) had mild autonomic neuropathy, 11 (12.5%) had moderate autonomic neuropathy, 5 (5.6%) had severe autonomic neuropathy.

By chi-square analysis, the p value is 0.524. The result is not significant at p <0.05. So, we found sex is not a risk factor for autonomic neuropathy in diabetes mellitus patient.

In the age group 31-40, 1 patient had severe and 2 patients had mild autonomic neuropathy. In the age group of 41-50, 6 patients had no autonomic neuropathy, 5 patients had mild autonomic neuropathy, 7 patients had moderate autonomic neuropathy, 7 patients had severe autonomic neuropathy. In the age group of 51-60, 6 patients had no autonomic neuropathy, 9 patients had mild autonomic neuropathy, 15 patients had moderate autonomic neuropathy, 8 patients had severe autonomic neuropathy. In the age group of 61-70, 3 patients had no autonomic neuropathy, 2 patients had mild autonomic neuropathy, 12 patients had moderate autonomic neuropathy, 2 patients had severe autonomic neuropathy. In the age group of 71-80, 1 patient had mild autonomic neuropathy, 2 patients had moderate autonomic neuropathy.

By using independent t test the p value is calculated as 0.643 which is not significant at p <0.05. By using binary logistic regression, so we found that age is not a risk factor for development of autonomic neuropathy in diabetes mellitus patient.

In the 5-8 years duration of diabetes group, 16 patients had no autonomic neuropathy, 5 patients had mild autonomic neuropathy, 6 patients had moderate autonomic neuropathy, 11 patients had severe autonomic neuropathy. In the 8.1-12 years duration of diabetes group, 9 patients had no autonomic neuropathy, 12 patients had mild autonomic neuropathy, 16 patients had moderate autonomic neuropathy, 11 patients had severe autonomic neuropathy. In the >=12.1 years duration of diabetes group, 4 patients had moderate autonomic neuropathy, 1 patient had severe autonomic neuropathy.

The p value is calculated as 0.003 which is significant at p <0.05. So, duration of diabetes is a risk factor for development of autonomic neuropathy in type 2 diabetes mellitus patient. With increase in duration of diabetes, chances of development of autonomic neuropathy increase.

In BMI group of <= 24.9 kg/[m.sup.2], 2 patients had no autonomic neuropathy, 2 patients had mild autonomic neuropathy, 2 patients had moderate autonomic neuropathy, 1 patient had severe autonomic neuropathy. In BMI group of <=25-29.9 Kg/[m.sup.2], 11 patients had no autonomic neuropathy, 15 patients had mild autonomic neuropathy, 16 patients had moderate autonomic neuropathy, 8 patient had severe autonomic neuropathy. In BMI group of 30-34.9 kg/[m.sup.2], 2 patients had no autonomic neuropathy, 5 patients had mild autonomic neuropathy, 14 patients had moderate autonomic neuropathy, 8 patient had severe autonomic neuropathy. In BMI group of 35-39.9 kg/[m.sup.2], 1 patient had moderate autonomic neuropathy, 1 patient had severe autonomic neuropathy.

BY using independent t test, p value is calculated as 0.0005 which is significant at p <0.05. We found that BMI is a risk factor for development of autonomic neuropathy. With increase in BMI, chances of development of autonomic neuropathy increases.

Out of total 88 cases, 15 patients (17.0%) didn't have autonomic neuropathy, 22 patients (24.0%) had mild autonomic neuropathy, 33 patients (37.5%) had moderate autonomic neuropathy, 18 patients (20.3%) had severe autonomic neuropathy.

So, the prevalence of autonomic neuropathy in our study is 81.8%. Among them mild is 24%, moderate is 37.5%, and severe is 20.3%.

DISCUSSION

In our study we found that the prevalence of autonomic neuropathy (TABLE-A) of diabetes patients of more than 5 years duration is 81.8%. Among them among them mild is 24%, moderate is 37.5%, and severe is 20.3%. In a study of S Aggarwal, et al found that the prevalence of DAN in the cohort studied was 70%. Amongst these, 22.9% had severe autonomic dysfunction with prevalence of definite and early neuropathy being 40% and 37% respectively. [7] Studies by Ewing et al [8] had found its prevalence as 63.93% with 39 out of 61 diabetics' examined testing positive for DAN whereas Valensi P. et al [9] in his French multicentre study in the year 2003 reported its prevalence as 51%. Nijhawan et al [10] documented its prevalence in 60% diabetics in India. The reported prevalence of DAN varies widely depending on the cohort studied and methods of assessment.

By chi-square analysis of Table-2. The p value is 0.524. The result is not significant at p <0.05. By using binary regression analysis so we found sex is not a risk factor for autonomic neuropathy in diabetes mellitus patient and there is no correlation of autonomic neuropathy with respect to sex of the diabetic patient. In a study of S Aggarwal, et al no correlation of DAN could be assessed with respect to sex of the patients. Valensi P, et al in his study they could not find any correlation of DAN with respect to sex of the diabetic patients. [9] By using independent t test of Table-4. The p value is 0.643. The result is not significant at p <0.05. By using binary logistic regression, so we found that age is not a risk factor for development of autonomic neuropathy in diabetes mellitus patient and there is no correlation of autonomic neuropathy with respect to age of the diabetic patient. In a study of S Aggarwal, et al no correlation of DAN could be assessed with respect to age of the patients. Valensi P, et al in his study they could not find any correlation of DAN with respect to age of the diabetic patients.

Development and degree of DAN is not an all or none phenomenon but a continuation of the progression of a disease process, its incidence increasing in direct proportion to the duration of the disease. [11] Table 6 shows, The p value is 0.003 (By using independent t test).the result is significant at p <0.05. So we found that duration of diabetes is a risk factor for the development of autonomic neuropathy. With increase in duration of diabetes there is increase in proportion of moderate and severe autonomic neuropathy. Only moderate and severe autonomic neuropathy found in patients those had >= 12-year duration of diabetes only moderate and severe autonomic neuropathy. Valensi P. et al [9] and Kempler et al [12] showed a significant correlation between prevalence of CAN and duration of diabetes (p= 0.026 and p<0.0001 respectively). P Feifer [13] even concluded that after a mean duration of 25 years of diabetes almost all diabetics will have autonomic dysfunction. A higher prevalence rate of CAN (70%) was observed with an early age of onset having mean duration of diabetes 2.67 [+ or -] 1.67 yrs. This further rose with increasing duration and all the cases with mean duration 14.25 [+ or -] 2.5 yrs. had autonomic dysfunction. Studies of S. Aggarwal et al, also found a linear relationship between the duration of disease and severity of dysautonomia. But in the present work, there was an increase in the severity of autonomic dis-function, 56.6% in 5-8 yrs duration of diabetes group to 82.9% in 9-12 yrs., duration group, to 100% in >12 yrs., duration group.

Table-8 shows, the p value is 0.0005 (By using independent t test). The result is significant at p <0.05. So, we found that BMI is a risk factor for the development of autonomic neuropathy. With increase in BMI of diabetic patient chances of development of autonomic neuropathy increases. There is no such study in which BMI is correlated with autonomic neuropathy in diabetes patient.

CONCLUSION

Diabetic autonomic neuropathy (DAN) is a common complication of type 2 diabetes mellitus. In our study, we found that the prevalence of DAN is 81.8%. So, DAN should be evaluated in all type 2 DM patients of > 5-year duration as most often ignored by most of the clinicians. DAN goes completely unrecognised by patients and physicians because of its insidious onset and protean multiple organ involvement. In our study, we found that high prevalence of autonomic neuropathy associated with increase in duration of diabetes and BMI. However, the present study involves a small number i.e. 88 cases; thus further studies involving larger number of cases is likely to throw better insight into the prevalence of diabetic autonomic neuropathy and its correlation over glycaemic control.

REFERENCES

[1] Paturi RV, Tripathy BB. Definition, diagnosis and classification of diabetes mellitus. RSSDI Text book of medicine. 3rd edn. Jaypee Brothers Medical Publishers Pvt. Ltd., 2014: p. 87-8.

[2] American Diabetic Association. Diagnosis and classification of diabetes mellitus. Diabetes Care 2013;36(Suppl 1):S67-74.

[3] Powers AC. Diabetes mellitus: diagnosis, classification and pathophysiology. Chap--417. In: Kasper D, Fauci A, Hauser S, et al. eds. Harrison's Principles of Internal Medicine. 19th edn. New York: McGraw-Hill Publication 2015: p. 2399-400.

[4] Wild S, Roglic G, Green A, et al. Global prevalence of diabetes: estimates for the year 2000 and projection for 2030. Diabetes Care 2004;27(5):1047-53.

[5] Anjana RM, Pradeepa R, Deepa M, et al. Prevalence of diabetes and prediabetes (impaired fasting glucose and/or impaired glucose tolerance) in urban and rural India: phase I results of the Indian Council of Medical Research-INdia DIABetes (ICMR-INDIAB) study. Diabetologia 2011;54(12):3022-7.

[6] Tang Z, Li D, Zhang X, et al. Comparison of the simplified International Index of Erectile Function (IIEF-5) in patients of erectile dysfunction with different pathophysiologies. BMC Urol 2014;14:52.

[7] Aggarwal S, Tonpay PS, Trikha S, et al. Prevalence of autonomic neuropathy in diabetes mellitus. Current Neurobiology 2011;2(2):101-5.

[8] Ewing DJ, Clarke BF. Diagnosis and management of diabetic autonomic neuropathy. BMJ (Clin Res Ed) 1982;285(6346):916-8.

[9] Valensi P, Paries J, Attali JR, et al. Cardiac autonomic neuropathy in diabetic patients: influence of diabetes duration, obesity, and microangiopathic complications--the French multicenter study. Metabolism 2003;52(7):815-20.

[10] Nijhawan S, Mathur A, Singh V, et al. Autonomic and peripheral neuropathy in insulin dependent diabetes. J Assoc Physicians India 1993;41(9):565-6.

[11] Diabetes Control and Complications Trial Research Group, Nathan DM, Genuth S, et al. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329(24):977-86.

[12] Kempler P, Tesfaye S, Chaturvedi N, et al. Autonomic neuropathy is associated with cardiovascular risk factors: The EURODIAB IDDM complications study group. Diabet Med 2002;19(11):900-9.

[13] Greene DA, Sima AF, Pfeifer MA, et al. Diabetic neuropathy. Annu Rev Med 1990;41:303-17.

Meghanad Meher (1), Jayanta Kumar Panda (2), Siddhartha Dash (3), Lavina Patnaik (4)

(1) Senior Resident, Department of General Medicine, AIMS, BBSR, Khordha, Odisha, India.

(2) Professor, Department of General Medicine, SLNMCH, Koraput, Odisha, India.

(3) Junior Resident, Department of General Medicine, SCBMCH, Cuttack, Odisha, India.

(4) Junior Resident, Department of General Medicine, SCBMCH, Cuttack, Odisha, India.

'Financial or Other Competing Interest': None.

Submission 23-02-2019, Peer Review 14-03-2019, Acceptance 18-03-2019, Published 25-03-2019.

Corresponding Author: Dr. Meghanad Meher, LIG-2/9, Nandighush Enclave, Ranasinghapur, BBSR, Khordha-751019, Odisha, India.

E-mail: megha.hrt@gmail.com

DOI: 10.14260/jemds/2019/192
Table 1. Gender Distribution of Study Population

Gender      Number   Percentage    Mean Age (Years)

Male          59        67%       57.5 [+ or -] 7.28
Female        29        33%       53.4 [+ or -] 8.45
Total         88        100%

Table 2. Age Wise Distribution Among Cases

Age Groups (Yrs.)       Male        Female       Total

31-40                 1 (1.1%)     2 (2.2%)    3 (3.04%)
41-50                19 (21.5%)    6 (6.8%)    25 (28.4%)
51-60                25 (28.4%)   13 (14.7%)   38 (43.1%)
61-70                12 (13.6%)    7 (7.9%)    19 (21.5%)
71-80                 2 (2.2%)     1 (1.1%)    3 (3.04%)

Table 1. Prevalence of Autonomic Neuropathy in Both
Sexes

  Sex               Diabetic Autonomic Neuropathy             Total

           Absent        Mild       Moderate      Severe

Male      9 (10.2%)   15 (17.0%)    22 (25%)    13 (14.7%)   59 (66%)
Female    6 (6.8%)     7 (7.9%)    11 (12.5%)    5 (5.6%)    29 (33%)

Table 2. Correlation of Autonomic Neuropathy with
References to Sex

                     DAN
Sex                                p-Value
               Absent   Present

Male             9        50        0.524
Female           6        23

Table 3. Prevalence of Autonomic Neuropathy in Different
Age Groups

                  Diabetic Autonomic Neuropathy            Total
Age
(Years)    Absent      Mild       Moderate     Severe

31-40        0       2 (2.2%)        0        1 (1.1%)    3 (3.4%)
41-50     6 (6.8%)   5 (5.6%)     7 (7.9%)    7 (7.9%)   25 (28.4%)
51-60     6 (6.8%)   9 (10.2%)    15 (17%)    8 (9.0%)   38 (43.1%)
61-70     3 (3.4%)   2 (2.2%)    12 (13.6%)   2 (2.2%)   19 (28.4%)
71-80        0       1 (1.1%)     2 (2.2%)       0        3 (3.4%)

Table 4. Correlation of Autonomic Neuropathy with
Reference to Age

                                      DAN
                                                              p-Value
                          Absent              Present

Age in Years        54.53 [+ or -] 7.5   55.63 [+ or -] 8.4    0.643
Mean [+ or -] SD

Table 5. Prevalence of Autonomic Neuropathy with
Reference to Duration of Diabetes

Duration             Diabetic Autonomic Neuropathy
of                                                           Total
Diabetes     Absent       Mild      Moderate     Severe
(Years)

5-8        16 (18.0%)   5 (5.6%)    6 (6.8%)   11 (12.5%)  38 (40.9%)
8.1-12     9 (10.2%)   12 (13.6%)  16 (18.0%)  11 (12.5%)  47 (53.4%)
>= 12.1        0           0        4 (4.5%)    1 (1.1%)    5 (5.6%)

Table 6. Correlation of Autonomic Neuropathy with
Reference to The Duration of Diabetes

                                      DAN
                                                              p-Value
                          Absent              Present

Duration of         6.20 [+ or -] 1.78   8.36 [+ or -] 2.55    0.003
Diabetes in Years
Mean [+ or -] SD

Table 7. Prevalence of Autonomic Neuropathy with
References to BMI

                     Diabetic Autonomic Neuropathy
BMI (Kg/m2)                                            Total
               Absent     Mild    Moderate   Severe

=< 24.9           2        2         2         1         7
               (2.2%)    (2.2%)    (2.2%)    (1.1%)   (7.9%)

25-29.9          11        15        16        8        50
               (12.5%)   (17%)    (18.0%)    (9.0%)   (56.8%)

30-34.9           2        5         14        8        29
               (2.2%)    (5.6%)   (15.8%)    (9.0%)    (33%)

35-39.9           0        0         1         1         2
                                   (1.1%)    (1.1%)   (2.2%)

>= 40             0        0         0         0         0

Table 8. Correlation of Autonomic Neuropathy with
References to BMI

                                   DAN
                                                            p-Value
                      Absent                Present

BMI in KG/M2    27.34 [+ or -] 2.32   29.15 [+ or -] 2.79   0.0005
Mean [+ or -]
SD

Table A. Overall Prevalence of Categories of Autonomic

Autonomic          Male          Female         Total
Neuropathy

Absent          9 (10.4%)       6 (7.8%)      15 (18.2%)
Mild           15 (17.04%)      7 (7.9%)      22 (24.0%)
Moderate         22 (25%)      11 (12.5%)     33 (37.5%)
Severe          13 (14.7%)      5 (5.6)       18 (20.3%)
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Article Details
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Title Annotation:Original Research Article
Author:Meher, Meghanad; Panda, Jayanta Kumar; Dash, Siddhartha; Patnaik, Lavina
Publication:Journal of Evolution of Medical and Dental Sciences
Article Type:Report
Geographic Code:9INDI
Date:Mar 25, 2019
Words:3634
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