RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA.

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. NAME OF THE DR. PUNEETH NAYAK S CANDIDATE AND PG IN ENT ADDRESS KIMS HUBLI - 580022.

2. NAME OF THE KARNATAKA INSTITUTE OF MEDICAL INSTITUTION SCIENCES, HUBLI-580022

3. COURSE OF THE M.S IN ENT STUDY AND SUBJECT

4. DATE OF ADMISSION 01-6-2011 TO THE COURSE CLINICAL EVALUATION OF 5. TITLE OF THE TOPIC SENSORINEURAL HEARING LOSS IN PATIENTS WITH DIABETES MELLITUS.

6. BRIEF RESUME OF INTENDED WORK:

6.1 NEED FOR THE STUDY:

Diabetes Mellitus is a disease known since antiquity. It is a multisystem disorder. Microangiopathy is the basic lesion and is considered to be the most important factor in the longterm complication of diabetes. As microangiopathy affects almost all parts of the body, its effect on the vessels of inner ear may lead to an impairment on hearing. The typical hearing loss in diabetes is described as a progressive, bilateral, sensorineural type deafness of gradual onset which affects predominantly higher frequencies and elderly patients. There is a decrease in auditory acuity which is similar to that due to presbyacusis, but those affected show a hearing loss greater than could be expected at that age. Exceptions to this pattern have been reported including acute onset of hearing loss or associated with Meniere like attacks, unilateral deafness with or without vestibular symptoms and low frequency involvement. Thus the study is being taken up to know the prevalence of sensorineural hearing loss in diabetes mellitus.

6.2 REVIEW OF LITERATURE:

1. Celik O. et al38 in 1996 studied the relationship between the diabetes mellitus and hearing loss in 75 patients with insulin dependent diabetes mellitus and 40 randomly selected sex and age matched non diabetic control subjects. They found that the hearing of the diabetic patients was significantly worse than the control subjects.

2. Virtaniemi et al37 in 1994 studied a series of 53 patients with insulin dependent diabetes 42 randomly selected non-diabetic controls. They found that the hearing level tended to be worse in diabetic patients, than in the controls.

3. Cullen and Cinnamond et al36 in 1993 studied the relationship between diabetes and sensorineural hearing loss in 44 insulin dependent diabetes mellitus patients and 38 aged and sex matched controls. They found the diabetics to be significantly deafer than the control population.

4. Cullen and Cinnamond et al36 in 1993 in their study found that male diabetics were deafer than female diabetics; a high and low frequency difference was noted in male diabetics, but only a high frequency difference was noted in diabetic females when compared with the control group.

5. Kurien et al42 in 1989 proved that the diabetics were significantly deafer than their control counterparts in the higher frequencies and even in lower frequencies in the 36-45 years age group.

6. Taylor and Irwin in 1978 showed that diabetics with family history of diabetes had worse hearing than those with no such history. 7. Friedmann et al34 in 1975 studied 20 diabetic patients with peripheral neuropathy, and the results were compared with those from a group pf normal age matched subjects. 11 patients showed bilateral symmetrical sensorineural deafness involving atleast one frequency.

8. Nagoshi et al31 in 1969 studied 109 diabetics on pure tone audiometer and concluded hearing loss in 54%. Later on in 1970 he studied a still bigger series of 127 cases and found hearing loss in 34.8% cases. In follow up study of the same patients he found severe perceptive deafness in 8.6% patients.

9. Dietzel et al25 in 1962 summarized that elderly diabetics are more prone to develop deafness than the younger ones.

10. Jorgenson and Buchs27 in 1962 studied 59 diabetics and found that 28 had hearing loss.

11. Vigi in 1950 was the first man who grouped his studies according to the age group, and concluded that diabetics below the age of 30 years had normal hearing; while patients between the age of 30 to 50 years had mild hearing loss(20%); while pateints above the age of 50 years had severe hearing loss(43%) and moderate hearing loss in 38 % diabetics. 6.3 OBJECTIVES OF THE STUDY:

1. Evaluate the relation of sensorineural hearing loss with duration of the diabetes mellitus.

2. Evaluate sexual preponderance of sensorineural hearing loss in diabetes mellitus.

3. Evaluation of sensorineural hearing loss in familial diabetes mellitus.

7. MATERIALS AND METHODS:

7.1 SOURCE OF DATA: All patients attending the out-patient department of KIMS with Diabetes mellitus during the study period of 1 year from November 2011 to October 2012.

7..2 METHOD OF COLLECTION OF DATA:

SAMPLE SIZE:

There are very few studies performed in the past on sensorineural hearing loss in diabetes mellitus. As this is an original and new study being undertaken at our institute. Hence all eligible cases that are encountered during the period of study will be taken up in the study. STUDY DESIGN AND SAMPLING:

This will be a time bound Discreptive study. All eligible patients with Diabetes mellitus are recruited into the study. Patients will be examined for other co-morbid conditions and thoroughly investigated using Blood sugar, Urine, Tuning Fork tests, PTA and Impedence Audiometry. The subjects are patients with Diabetes mellitus. This group is further analysed with respect to the following prognostic factors : 1. Age 2. Sex 3. Signs and symptoms 4. Previous medical treatment 5.Family history of diabetes mellitus 6.Co-existing morbidities

Appropriate statistical test will be used to analyse the data of the group as the need arises.

INCLUSION CRITERIA:

Patients with symptoms and signs of Diabetes Mellitus confirmed by:-  Fasting blood sugar level more than 100mg%.  1st hour post prandial blood sugar level of more than 200mg %.  Random blood sugar level of more than 200mg% in patients with symptoms of diabetes mellitus.

EXCLUSION CRITERIA: 1. History of noise exposure and ototoxic drug intake. 2. Hearing difficulty caused by other diseases. 3. Debilitaing patients with Diabetes mellitus.

7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR

INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR

OTHER HUMANS OR ANIMALS? IF SO DESCRIBE BRIEFLY. Yes.

 Pure Tone Audiometry.  Impedence Audiometry.

7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR

INSTITUTION IN CASE OF 7.3?

Yes, ethical clearance has been obtained from ethical committee of

KIMS, Hubli.

8. LIST OF REFERENCES: 1. Celik O. Yalcin S, and Celebi H. “Hearing loss in insulin dependent diabetes mellitus”. Auris Nasus Larynx, 1996; 23: 127-132. 2. Taylor I G and Irwin J “Some audiological aspects of diabetes mellitus”. J Laryngol Otol, 1978; 92:99-113. 3. Virtaniemi J. Laakso M. and Nuutinen J. et al “Hearing thresholds in insulin dependent diabetic patients”. J Laryngol otol, 1994; 15: 109-113. 4. Cullen J.R and Cinnamond M.J “Hearing loss in diabetics”. J Laryngol Otol, 1993; 107: 179-182. 5. Kurien M. Thomas K. and Bhanu T.S. “Hearing thresholds in patients with diabetes mellitus”. J Laryngol Otol, 1989; 103: 164-168. 6. Friedmann S.A. Schulman R.H. and Weiss S. “Hearing and diabetic neuropathy”. Arch Int Med, 1975; 135: 573-576. 7. Nagoshi Y. Oshita F. Hayakawa K and Nakayama T. “The studies of hearing disorder on diabetics”. Audiology Japan. 1969; 12: 155-159. 8. Dietzel K. “Diabetes und gehr. In Internazional symposium ber diabetes fragen”. Academic Verlag, Berlin. October 1962;1-3. 9. Jorgenson M.B. “The inner ear in diabetes mellitus”. Arch Otolaryngol. 1961; 74:373-381. 10. Vigi F. Quoted by Irwin et al in J Laryngol Otol, 1978; 99-113. 9. SIGNATURE OF THE CANDIDATE

10. REMARKS OF THE GUIDE

DR.RAVEENDRA P GADAG MS 11. 11.1 NAME AND DESIGNATION OF ASSOCIATE PROFESSOR, THE GUIDE DEPARTMENT OF ENT, HEAD AND NECK SURGERY. KIMS HUBLI.

11.2 SIGNATURE

11.3 CO-GUIDE, IF ANY ----- 11.4 SIGNATURE OF CO-GUIDE ----

11.5 HEAD OF THE DEPARTMENT DR.UMESH S. NAGALOTIMATHMS,DNB PROFESSOR AND HEAD, DEPARTMENT OF ENT, HEAD AND NECK SURGERY. KIMS HUBLI

11.6 SIGNATURE

12 12.1 REMARKS OF THE CHAIRMAN AND THE PRINCIPAL

12.2 SIGNATURE

From: Date: 21/10/2010 Dr.Puneeth Nayak S, Post Graduate Student, Department of ENT, KIMS, Hubli

To, The Principal KIMS, Hubli.

Sub: Forwarding of Synopsis of Dissertation topic to the Rajiv Gandhi University of Health Sciences, Bangalore for registration.

Through proper channel

Respected Sir,

With reference to the above subject here in I submit my synopsis for the registration of dissertation topic that is “CLINICAL EVALUATION OF

SENSORINEURAL HEARING LOSS IN PATIENTS WITH DIABETES

MELLITUS”. Hence I request your kind self to forward the same to the Rajiv

Gandhi University of Health Sciences, Bangalore, for Registration and do the needful.

Thanking you, Yours Faithfully,

Dr. Puneeth Nayak S