A prospective case control study of the Lower Esophageal Sphincter Pressure in patients with Type II Diabetes Mellitus presenting with heartburn

Pavitra Vyshnavi Yogisparan, R (2018) A prospective case control study of the Lower Esophageal Sphincter Pressure in patients with Type II Diabetes Mellitus presenting with heartburn. Masters thesis, PSG Institute of Medical Sciences and Research, Coimbatore.

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Abstract

INTRODUCTION: Evolution has made man to be one of the most complex beings in the world. May it be from the beginning of time in accordance with the religious scriptures or scientific theories starting with “The Big Bang” what we have learned is that all but one essential concept, all living things need food and water to survive. How does this food travel down the path from being ingested to broken down and absorbed to get utilized is a complex process. In this entire complex of mechanical systems the Lower Esophageal Sphincter is one of the major gateways into the world within our bodies. AIM OF THE STUDY: To evaluate the Lower Esophageal Sphincter Pressure in patients with Type II Diabetes Mellitus, presenting with heartburn, by esophageal manometry studies. OBJECTIVES: 1. To find the correlation between the severity of the GI symptoms and severity of type II diabetes mellitus by use of glycemic index. 2. To determine whether these tests can be used as early indicators of GERD (Gastroesophageal Reflux Disease) in patients with Type II Diabetes Mellitus. 3. To study the pathophysiology of gastro esophageal reflux symptoms in patients with type II diabetes. MATERIALS AND METHODOLOGY: The study was conducted in the Gastrointestinal Motility Laboratory in the Department of Gastroenterology, PSG IMS&R, after getting clearance from the Institutional Human Ethics Committee (IHEC). Informed and written consent was obtained from all those who participated before initiation of the study. Thirty-five type II diabetes mellitus patients and thirty-five non-diabetic patients presenting with upper GI symptoms were included in this study. Patients with type II diabetes presenting with upper GI symptoms constituted the study group. Non-diabetes patients presenting with upper GI symptoms were labeled to be in the control group. Both these groups were subjected to High Resolution Esophageal Manometry. A case group of 35 diabetics who presented with heartburn and were referred for high-resolution manometry were included in the study. During the duration of one-year study period all diabetics who presented with heartburn and were asked to undergo high-resolution manometry and fell into the inclusion criteria were included in this study. The control group was age matched with non-diabetic patients who presented with heartburn and were referred to undergo high-resolution manometry. INCLUSION CRITERIA: STUDY GROUP: 35 Type II Diabetes Mellitus patients presenting with heart burn. EXCLUSION CRITERIA: 1. Pregnancy, 2. Alcoholics, 3. Type I Diabetes, 4. Gestational Diabetes, 5. Carcinoma of Upper GI tract, 6. Upper GI motility disorders, 7. On drugs which alter the sphincter tone by acting on the smooth circular muscles of the LES. The following parameters were noted for both the groups during high resolution manometry: 1. Basal Lower esophageal sphincter pressure, 2. The Basal expiratory pressure, 3. EGJ- Cl, 4. Median Integrated Relaxation Pressure, 5. Body Motility. The results of both the groups were subjected to statistical analysis and significance determined. RESULTS: Mean age of Non diabetics and Diabetics: The age of the 35 controls had a mean and SD of 51.23± 10.393 years. The diabetics in the study group had a mean and SD of 54.23± 11.330 years and the difference was found to have a p value of 0.252, which is statistically not significant. This shows that the age of both the groups is matched in our study. Comparison of sex in the Non-diabetic and Diabetic groups: The distribution of sex in the control group was as follows, there were 11 females (31.4%) and 24 males (68.6%) in the non diabetic group and 14 females (40.0%) and 21 males (60.0%) in the diabetic study group. After analysis through Pearson Chi-Square test significance was found to be .454, which is statistically not significant. Basal Lower esophageal Sphincter Pressure: The numbers for this is as follows: Normal count in control group was 25 (71.4%) and case group was 26 (74.3%) having a total number of 51 members. In the elevated category in the control group was 2 (5.7%) and case group was 3 (8.6%) bringing the total to a number of 5 members. Finally in the reduced category a count of 8 (22.9%) in the control group and 6 (17.1%) in the case group bringing the total to a value of 14 members. Upon performing Pearson Chi-Square test significance value of .777 (not significant) was obtained. Body Motility: A total of 62 of the 70 individuals had propagative type of motility of this 31 were in the control group and 31 were in the case group. 8 out of the 70 had ineffective motility and this was also evenly distributed as 4 in each group. There was no significance found in this comparison (p value 1.000). Mean Basal Inspiratory Pressure: The Mean Basal Inspiratory Pressures which were measured for the control group had a mean and SD of 28.246 ± 11.362 and diabetic group a mean and SD of 22.627 ± 9.125. These values had a p value of 0.026 which was found to be statistically significant. Mean Basal Expiratory Pressure: The Mean Basal Expiratory Pressure recorded during manometry for the control group of 35 members in number, had a mean and SD of 17.617 ± 9.17. In the diabetic group consisting of 35 members the mean basal expiratory pressure was found to have a mean and SD of 23.514 ± 9.66. P value was found to be statistically significant with a value of 0.011. EGJ-CI: The Esophageal-Gastric Junction Clearance recorded for the control group of 35 members was a mean and SD of 29.920 ± 19.001. In the diabetic group the EGJ-CI was found to be a mean and SD of 31.68 ± 13.635. Upon performing independent t test for both these groups the p value was found to be .657, which shows there was no statistical significance. Median Integrated Relaxation Pressure: The Median Integrated Relaxation Pressure for the control group’s mean and SD was found to be 7.877 ± 5.886. The study group of 35 diabetic patients had a mean and SD of 6.337 ± 5.147. Upon performing independent t test it found that the p value for this was 0.248, which showed no statistical significance CONCLUSION: As mentioned previously controversy can lead to the discovery of new information and theories, which sets forth a path towards the betterment of treatment. With the high prevalence of diabetes and gastro esophageal reflux disease it lies crucial to find a reason and create a solution for these issues. The age in our study was matched therefore showing in comparison with other studies that with increasing age there lay an increase in the incidence of GERD as age progresses regardless of the presence of diabetes mellitus. Gender in relation to the control group and diabetic group was also found to be matched. This gave proper comparison when esophageal parameters were checked between males of the two groups and females of the two groups. The comparison of these parameters is discussed below. More than 80% of both study and control groups had propagative motility unlike various other studies, which showed, decreased motility. Above 70% of the control and study group showed normal basal lower esophageal sphincter pressures and the rest had either hypertensive sphincter pressures or hypotensive sphincter pressures. Mean basal inspiratory pressure was increased in the study group when compared to that of the control group but was within the normal range. On comparison of mean expiratory pressure between males and females in the non diabetic group the females had high values when compared to the males, this may be due to the benefits of estrogen as mentioned above, and that all the women in the control group were within the reproductive age group. The EGJ-CI, denotes the esophagogastric junction barrier function. On comparison between those who were under the HbA1c value of less than 6.5 gms/dL and above 6.5 gm/dL the uncontrolled diabetic patients showed a high mean rank when compared to those who had glycemic control. These results may help to prove that uncontrolled diabetes may lead to complication of diabetes, one of which is autonomic gastro neuropathy due to the damage of the vagus nerve. It is within the normal range of median integrated relaxation pressure in both groups. Regarding the duration of diabetes, mean expiratory pressures was lower when compared with those who were diabetic for more than 5 years. This may be attributed to the fact that those who have had diabetes for a shorter duration still had not established proper glycemic control when compared to those who have had diabetes for longer duration. However this is not a definitive result, as comparison should be done between the short duration and glycemic control for conclusive statements to be made. It was found in our study, even though certain manometric parameters had statistical significance they all fell within the normal range. This shows that the presence of diabetes has less impact on these manometric parameters. Even though the data found in this study can be helpful in adding to the controversies which lie between GERD and its association with diabetes mellitus, it can be helpful in coming to a conclusion about the duration and control of diabetes and its effect on upper gastrointestinal symptoms. To further validate this study, it can be continued over a longer duration of time with more number of patients and also with the addition of healthy volunteers to under high-resolution esophageal manometry in order to come to a definite conclusion.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Gastroesophageal Reflux Disease (GERD) ; Type II Diabetes Mellitus ; High Resolution Esophageal Manometry ; Heartburn.
Subjects: MEDICAL > Physiology
Depositing User: Subramani R
Date Deposited: 17 Aug 2018 03:15
Last Modified: 17 Aug 2018 03:26
URI: http://repository-tnmgrmu.ac.in/id/eprint/9285

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