European Journal of Cardiovascular Medicine

Type 2 DM is the predominant form of diabetes worldwideaccounting for 90% of cases globally.[1] India is in the midst of an everincreasing epidemic of DM. Type 2 DM accounts for >90% of all patientswith Diabetes in India.[2]

Peripheral arterial disease (PAD) is one of the macrovascular complications of type 2 diabetes mellitus. Unlike other complications, it has received little attention in the Indian medical literature. There is significant difference in the reported prevalence of PAD and its associated risk factors between Indian and Western studies.[3]

PAD is not uncommon but commonly neglected condition. Thecardinal symptom is Intermittent Claudication (IC) but majority of patientsare asymptomatic.Epidemiological studies show that there will be a rise in thePrevalence of Diabetes Mellitus (DM) by 2025. The diabetic populations already the largest in the world, will double reaching more than 57 million inIndia. People with diabetes are prone to develop Peripheral Neuropathy,PAD, Nephropathy and Retinopathy. [4]

The correct prevalence of PAD in persons with diabetes has beencomplex to establish because of the lack of symptoms and insensitive meansof diagnosis. The ABI Ankle Brachial Index (ABI) has a high sensitivity and specificity forangiographicallyproven disease. Diagnosing PAD through ABI, theprevalence in individuals with DM > 40 years of age was 20%.[5]

Peripheral arterial disease, which is caused by atherosclerotic occlusion of the arteries to the legs, is an important manifestation of systemic atherosclerosis. The age adjusted prevalence of peripheral arterial disease is approximately 12 percent, and the disorder affects men and women equally.[6, 7]

Patients with peripheral arterial disease, even in the absence of a history of myocardial infarction or ischemic stroke, have approximately the same relative risk of death from cardiovascular causes as do patients with a history of coronary or cerebrovascular disease. Prevalence of PVD, although less compared to the white population, may also pose a major problem due to the large number of diabetic patients with foot infections in India.[8, 9]

In patients with peripheral arterial disease, the rate of death from all causes is approximately equal in men and women and is elevated even in asymptomatic patients. The severity of peripheral arterial disease is closely associated with the risk of myocardial infarction, ischemic stroke, and death from vascular causes. The lower the Ankle Brachial Index (ABI), the greater the risk of cardiovascular events. Patients with critical leg ischemia (the most severe clinical manifestation of peripheral arterial disease) who have the lowest ABI values, have an annual mortality of 25 percent.[10, 11]

PAD is said to be the third leading cause of atherosclerotic cardiovascular morbidity, following coronary artery disease (CAD) and stroke.[5]

In present study we have screened one hundred fifty (150) patients of Type2 Diabetes Mellitus for PAD and assessed their relation with degree and duration of hyperglycemia as well as with Coronary Artery Disease(CAD).

Study Centre: The present study was conducted in the Department of Medicine, R. D. Gardi Medical College and C. R. Gardi Hospital, Ujjain, M.P.

Study Duration: 1.5 Year

Sample Size: 150 cases

Study Design: Cross sectional study

Sampling Method: Simple random sampling

Ethical Clearance: Ethical clearance for the study was obtained from Institutional Ethics Committee, R. D. Gardi Medical College, Ujjain.

Inclusion Criteria

1. All type 2 Diabetes Mellitus patients attending Medicine OPD andIPD of R. D. GARDI MEDICAL COLLEGE AND C. R. GARDIHOSPITAL, UJJAIN (M.P.) irrespective of age, sex and duration ofdiabetes were included in the present study.

Exclusion Criteria

1. Patients with Symptoms including intermittent claudication asexertional leg pain relieved by resting
2. Patients with Symptoms of ischemic limb, cutaneous ulceration,gangrene and wound healing failure
3. History of revascularization procedure, amputation and PAD relatedhospitalization
4. Smokers (ex-smokers and current smokers)
5. Type 1 Diabetes mellitus

Statistical Analysis

The data regarding history, clinical examination, routine and special investigations of study cases and controls were entered in pretested proforma and observations were tabulated. Statistical software namely SPSS 23.0 was used for the analysis of data and Microsoft word and excel have been used to generate graphs, tables and descriptive statistics.

All 150 patients were subjected to detailed history, thorough clinical examination and laboratory investigations as per proforma especially designed for the study, which included examination of risk factors and detailed assessment of peripheral arterial system. Patients were also examined for coronary artery disease and microvascular complications of Type 2 Diabetes Mellitus.

The study result comprised of one hundred fifty cases of type 2 diabetes mellitus that were asymptomatic for Peripheral Arterial Disease (PAD) and their association with HbA1c, duration of DM & CAD were studied and tabulated as under.

In the present study, out of one hundred fifty study cases, maximum sixty eight (59.1%) males and forty seven (40.9%) females were in the fifth and sixth decade followed by eleven (39.3%) males and seventeen (60.7%) females in the seventh and eighth decade whereas four (57.14%) males and three (42.86%) females were below the age of forty years .

The Mean age with SD in males was 53 ± 9.5 years while that in females 54.9 ± 10.5 years. (Table 1, Graph 1)

Table 1: Age wise Gender Distribution of Study Cases (n=150)

Graph 1. Bar diagram showing Age Wise Gender Distribution Of Study Cases

Study cases were screened for PAD using ABI and Color Doppler. Amongst the study cases Using ABI 21 (14%) cases while using Color Doppler 24 (16%) cases were diagnosed to have PAD.  Color Doppler is more sensitive diagnostic tool than ABI to diagnose PAD.

Prevalence of PAD in our study was 16%.

In present study of one hundred fifty cases, one hundred two (68%) were hypertensives while forty eight (32%) were normotensives whereas forty one (27.33%) cases had evidence coronary artery disease while one hundred nine (72.67%) had no CAD. Hence Prevalence of Hypertension was 68% while that of CAD 27.33% in study cases.(Table 2)

Table 2. Prevalence of Hypertension and Coronary Artery Disease in Study Cases (n=150)

In present study of one hundred fifty cases, seventy seven (51.33%) were having HbA1c > 7% while seventy three (48.67%) had HbA1c > 7%.Mean HbA1c value with SD was 7.9±1.4%.

Seventy three (48.67%) were having Duration of DM less than five years while forty five (30%) had it more than ten years and thirty two (21.33%) had duration of DM from five to ten years.Mean duration of DM with SD was 7.1 ± 5.6 years. (Table 3)

Table3. HbA1c Levels and Duration of Diabetes Mellitus of StudyCases(Table 12) (n=150)

In the present study of One hundred fifty cases, maximum seventy three cases had duration of DM less than five years and among them only two(2.7%) cases had PAD, followed by forty five cases having duration more than ten years, eighteen (40.0%) had PAD. Duration of DM varying from five to ten years, the number of cases were thirty two and among them four (12.5%) cases had PAD. It was observed that the duration of DM and the chances of PAD increase hand in hand.

After application of Chi square test to the above observations, the Chi square value 29.128 and p value 0.000 which was much less than 0.05. Hence there was strong statistically significant association of Duration of DM with PAD in study cases. (Table 4, Graph 2)

Table 4 : Association of Duration of Diabetes Mellitus with PAD inStudy Cases (n=150)

Graph 2. Bar Diagram showing Association Of Duration of Diabetes Mellitus With PAD In Study Cases

In the present study of One hundred fifty cases, seventy three cases had HbA1c < 7% and among them only six (8.2%) cases had PAD while seventy seven cases had HbA1c >7% and among them eighteen (23.4%) had PAD. It was observed that as the HbA1c level increased, the chances of PAD also increased.

After application of Chi square test to the above observations, the Chi square value 6.406 and p value 0.011 which was less than 0.05. Hence there was statistically significant association of HbA1c level with PAD in study cases. (Table 5, Graph 3)

Table 5. Association of HbA1c with PAD In Study Cases (n=150)

Graph 3. Bar Diagram Showing Association OfHbA1c with PAD In Study Cases

In the present study of One hundred fifty cases, one hundred and nine cases had no evidence of CAD and among them only ten (9.2%) cases had PAD while forty-one cases had the evidence of CAD andamong them fourteen (34.1%) had PAD. It was observed that the chances of PAD increased in presence of CAD in study cases. (Table 6)

After application of Chi Square test to the above observations, the Chi square value 13.824 and p value 0.000 which was much less than 0.05. Hence there was strong statistically significant association of presence of CAD with PAD in study cases.(Table 6, Graph 4)

Table 6. Association of Coronary Artery Disease with PAD In Study Cases (n=150)

Graph 4. Bar Diagram ShowingAssociation Of Coronary Artery Disease With PAD In Study Cases

In the present study of 150 patients we went through the assessment of Degree and duration of Hyperglycemia and we also examined for asymptomatic PAD and development of CAD.

Degree of Hyperglycemia (HbA1c) and its association with Asymptomatic PAD

In present study, seventy seven (51.33%) were having HbA1c > 7% while seventy three (48.67%) had HbA1c < 7%. Mean HbA1c value with SD was 7.9 ± 1.4 %.

Agarwal AK et al[3] in 2012 obtained HbA1c > 7% in 47.95% of his study cases. Soyoye DO et al[12] in 2016 and Agarwal AK et al[3] in 2012, obtained mean HbA1c with SD 7.9 ± 2.1% and 7.1 ± 0.9% respectively in his study.

In the present study, it was observed that as the HbA1c level increased, the Prevalence of PAD also increased. The Chi square value 6.406 and p value 0.011 showing statistically significant association of HbA1c level with PAD in study cases.

Table 7. Comparative statement of mean HbA1c of various authors with study result

Duration Of Diabetes and its association with Asymptomatic PAD

Seventy-three (48.67%) cases were having Duration of DM less thanfive years while forty five (30%) had it more than ten years and thirty two(21.33%) had duration of DM from five to ten years.

Mean Duration of DM with SD was 7.1 ± 5.6 years.Agarwal AK et al[3] in 2012 and Belli B et al[13] in 2015 obtainedmean Duration of DM with SD as 8.8 ± 3.8 years and 8.9 ± 3.78 yearsrespectively.

In the present study, PAD was observed in 1.33% in cases havingDuration of DM less than five years, 2.67% in five to ten years and 12% inmore than ten years duration. It was observed that the Duration of DM andthe Prevalence of PAD increases hand in hand. The Chi square value 29.128and p value 0.000 showing strong statistically significant association ofDuration of DM with PAD.

Similar correlations obtained by Agrawal RP et al[9] in 2004 while The Fremantle Diabetes Study[15] in 2006 and Agarwal AK et al[3] in 2012reported that Duration of DM should be considered as predictor of PAD.

Coronary artery Disease and its association with Asymptomatic PAD

In present study, one hundred and two cases were hypertensive so the Prevalence of Hypertension was 68% whereas forty one cases had evidence CAD and hence the Prevalence of CAD was 27.33%.

Agarwal AK et al [3] in 2012, Belli B et al [13] in 2015 and Pandya HP et al[16] in 2015 obtained Prevalence of Hypertension as 52.7%, 41% and 17.6% respectively. However Agarwal AK et al [3] in 2012, Belli B et al [13] in 2015, Agrawal RP et al[9] in 2004 and Sarangi S et al [17] in 2012 studied

CAD and obtained its Prevalence as 28%, 42%, 19.2% and 24.73% respectively.

In the present study, 6.67% had PAD in study cases with no evidence of CAD while 9.33% had PAD in study cases with the evidence of CAD. It was observed that the Prevalence of PAD increased in presence of CAD.

The Chi square value 13.82 and p value 0.000 showing strong statistically significant association of presence of CAD with PAD in study cases.

Belli B et al[13] in 2015, in his study PAD was present in 13 % cases having CAD and Agarwal AK et al[3] in 2012 obtained 7.53% while in the present study it was 9.33% .

n the present study, the Prevalence of PAD was 16%. The Prevalence of PAD in study cases increased with increased duration of DM. There was statistically significant correlation of PAD with HbA1c. Prevalence of asymptomatic PAD also increased in presence of Hypertension and CAD. All of them had statistically significant correlationwith PAD.

LIMITATIONS

The sample size was limited (one hundred fifty)in the present study to conclude the exact Prevalence of PAD in type 2 DMcases without symptomatic PAD.Type 2 DM cases with asymptomatic PAD were not subjected to DigitalContrast Angiography, CT angiography and MR Angiography which are theother diagnostic tools for PAD.

ACKNOWLEDGMENT           

We extend our sincere gratitude toward, institutional ethics committee, whole department of medicine, statistician, and hospital management to allow us and to help us in every manner for smooth conduction of this study. We are also thankful to all the study participants for being valuable part of our study project.

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