RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA.
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION.
1. NAME / Dr. EDWIN GEORGE2. ADDRESS / DEPARTMENT OF GENERAL
MEDICINE
BMCRI,
BANGALORE - 560 002
3. NAME OF THE INSTITUTION / BANGALORE MEDICAL COLLEGE
AND RESEARCH INSTITUTE,
BANGALORE - 560 002
4. COURSE OF STUDY AND SUBJECT
/ MD GENERAL MEDICINE
5. DATE OF ADMISSION TO COURSE / 19 JULY 2013
6. TITLE OF THE TOPIC
/ COMPARATIVE STUDY OF THE OCCURENCE OF DIABETIC COMPLICATIONS IN TYPE 2 DIABETIC PATIENTS WITH AND WITHOUT THYROID DYSFUNCTION6. Brief resume of intended work:
6.1 Need for the study
Type 2 diabetes mellitus (T2 DM) is a growing problem in our country. Based on current trends, the international diabetic federation projects that 438 million individuals will have diabetes by the year 20301. The prevalence of thyroid disorder in diabetic population was reported to be 13.4%.2Both Hyper and hypothyroidism have been associated with insulin resistance which has been reported to be the major cause of impaired glucose metabolism in T2 DM. In subclinical hypothyroidism , GLUT 2 expression is reduced , leading to insulin resistance.
Studies have already reported that the complications arising out of long standing diabetes like diabetic nephropathy, retinopathy, cardiovascular complications are more in diabetic patients with thyroid dysfunction. This study intends to determine the prevalence of thyroid dysfunction in diabetic patients as well as to compare the complications of diabetes in diabetic patients with and without thyroid dysfunction. As complications arising out of diabetes are more in patients with thyroid dysfunction, early correction of thyroid dysfunction is important.So a study comparing the occurence of complications of diabetes in diabetic patients with and without thyroid dysfunction is truely needed
6.2 Review of literature
The prevalence of thyroid disorder in diabetic population was reported to be 13.4% with higher prevalence (31.4%) in female T2DM patients as compared to (6.9%) in male T2DM patients2. The prevalence of thyroid dysfunction in T2DM patients was reported to be 12.3% in Greece and 16% in Saudi Arabia by Akbar et al3,4
American thyroid association(ATA) recommends TSH estimation from 35years, and every 5years thereafter in all adults; high risk persons like diabetes may require more frequent tests .ATA reccomends screening of TSH in every patient with newly detected diabetes5 Sub-clinical hypothyroidism and hyperthyroidism have both been linked to increased cardiovascular risk in diabetic patients6
Overall population prevalence of subclinical hypothyroidism is around 5-10%7.
Sub-clinical hypothyroidism was associated with a higher frequency of nephropathy8
Patients with subclinical hypothyroidism had a higher prevalence of retinopathy9
Prevalence of hypothyroidism is quite high in type 2 DM patients above 45 years and more so if their BMI is over 25.10
Overt hypothyroidism results in increase in total and LDL cholesterol as well as changes in other lipoproteins and apolipoprotein concentrations.11
In NHANES 3 cohort, mean total cholesterol concentration was higher in subclinical hypothyroid subjects than euthyroid controls11
Subclinical hypothyrooidism was associated with greater prevalence of nephropathy compared to euthyroids8
Other direct and indirect influence of subclinical hypothyroidism upon vascular system have been identified in some detail, most consistent being left ventricular diastolic dysfunction together with an increase in systemic vascular resistance and arterial thickness.11
In women with type 2 DM without known thyroid disease, subclinical hypothyroidism is a common but incidental finding11
Groups at particular risk of subclinical hypothyroidism include those with other autoimmune disease such as Type 1 DM11.
6.3 Objectives of the study
Primary Objectives:
To compare the complications of diabetes in diabetic patients with and without thyroid dysfunction
Secondary Objective:
To find the occurence of thyroid dysfunction in diabetic patients.
7. Materials and methods:
7.1 SOURCE OF DATA
The present study will be conducted in the Department of Medicine, Victoria hospital and Bowring and Lady Curzon hospital, Bangalore Medical College and Research institute, Bangalore
7.2 Method of collection of data
A. STUDY DESIGN: case control study.
B. STUDY PERIOD: October 2013 to April 2015.
C. PLACE OF STUDY: OPD and wards of victoria and bowring and lady curzon hospital attached to BMCRI, Bangalore.
D.SAMPLE SIZE: 30 cases and 30 controls.
E. INCLUSION CRITERIA
1. Age more than 18 years.
2. Patients with DM who have consented for the study
F. EXCLUSION CRITERIA
1.Age less than18 years.
2. Patients taking drugs affecting thyroid profile
F. METHODOLOGY
After obtaining clearance and approval from the Institutional Ethics Committee of BMCRI, type two diabetic patients satisfying the inclusion criteria (approximately 150 to 200 patients) will be screened with thyroid function tests till the required sample size of cases and controls is obtained. Type two diabetes mellitus patients with known thyroid dysfunction will also be included in the study.
CASES: Diabetic patients with thyroid dysfunction satisfying the inclusion and exclusion
criteria
CONTROLS: Diabetic patients without thyroid dysfunction, satisfying the inclusion
criteria
Cases and controls will be studied according to the proforma (annexure 3) and with the
below enumerated investigations, the complications of DM will be
compared among cases and controls over a period of 18 months
INVESTIGATIONS
CBC
FBS,PPBS,HbA1C
RFT- to assess diabetic nephropathy
Urine Routine Examination – to evaluate proteinuria
Fasting Lipid Profile
T3,T4,TSH
ECG
ECHO CARDIOGRAM
NERVE CONDUCTION STUDY-In patients with paresthesia
H. Method of analysis:
Chi square test for assessing categorical variables
Student t test for assessing numerical variables
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? if so, please describe briefly.
Yes, on humans. Appropriate laboratory investigations as part of diabetic workup which are routinely done in the hospital like ECHOCARDIOGRAPHY,USG,NCS.
7.4 Has ethical clearence been obtained from your institution in case of 7.3
Applied for approval of Ethical Committee . Approval awaited.
7.5 List of references
1.Harrisons principles of internal medicine, 18th edition, page 2969
2..P. Perros, R. J. McCrimmon, G. Shaw, and B. M. Frier, Frequency of thyroid dysfunction in diabetic patients: value of annual screening,Diabetic Medicine, vol. 12, no. 7, 1995, pp. 622–627,
3. D. H. Akbar, M. M. Ahmed, and J. Al-Mughales, Thyroid dysfunction and thyroid autoimmunity in Saudi type 2 diabetics,Acta Diabetologica, vol. 43, no. 1, 2006, , pp. 14–18.
4.Chaoxun Wang , The Relationship between Type 2 Diabetes Mellitus and Related Thyroid Diseases , Journal of Diabetes Research,Volume2013(2013), Article ID390534, 9 pages
5.P. W. Ladenson, P. A. Singer, K. B. Ain et al., “American thyroid association guidelines for detection of thyroid dysfunction,”Archives of Internal Medicine, vol. 160, no. 11, 2000, pp. 1573–1575.
6. Biondi B, Cooper DS. The clinical significance of subclinical thyroid dysfunction.Endocr Rev2008;29:76–131.
7. Jayne A Franklyn. The thyroid – too much and too little across the ages. The
consequence of subclinical thyroid dysfunction.DOI- 10.1111/cen.2011
8.Chen HS, Wu TE, Jap TSet al.Subclinical hypothyroidism is a risk factor for nephropathy and cardiovascular diseases in type 2 diabetic patients.Diabet Med2007;24:1336–44.
9.Yang JK, Liu W, Shi J, Li YB. An association between subclinical hypothyroidism and sight-threatening diabetic retinopathy In type 2 diabetic patients.Diabetes Care2010,33:1018–20.
10. Laloo Demtrost andSalam Ranabir ,Thyroid dysfunction in type 2 diabetes mellitus: A retrospective study, Indian J Endocrinol Metab.2012 December;16(Suppl 2): S334–S335.
11. S.A.P Chubb, W. A Davis, Z. Inman , T.M.E Davis. Prevalence and progression of
subclinical hypothyroidism in woman with Type 2 DM. The Fremantle diabetes study.
DOI -10.1111/j.1365-2265.2005.02246.x
8. Signature of candidate9. Remarks of the guide / The prevalance of thyroid disorder in diabetic population is around 13.4%.India being the diabetic capital of the world and as the complications of diabetes are reported to be more in diabetic patients with thyroid disorder in various studies ,a comparative study of the occurence of diabetic complications in diabetic patients with and without thyroid dysfunction will be beneficial
10. Name and designation of
guide: / DR NIRMALA A.C
ASSSOCIATE PROFESSOR
DEPT OF GEN MEDICINE
BMCRI
BANGALORE
10.1 Signature of guide
10.2 Head of department: /
DR PRABHAKAR B. MBBS,MD.
PROFESSOR & HOD
DEPT OF GENERAL MEDICINE
BMCRI
BANGALORE
10.3 Signature
11.1 Remarks of the chairman and principal
11.2 Signature
ANNEXURE 1
INFORMED CONSENT
I have been explained, in a language understood by me about the study entitled “COMPARATIVE STUDY OF THE OCCURENCE OF DIABETIC COMPLICATIONS IN DIABETIC PATIENTS WITH AND WITHOUT THYROID DYSFUNCTION”
I have been explained about the procedures and investigations that will be done during this study. I have no objections to sharing my medical information and details in case records with the investigators of this study. Personal identity will not be revealed but data may be used for publication / dissertation purpose.
I understand that my participation in this study is entirely voluntary and I am willing to take part in this study.
Place: Signature:
Date: Name:
ANNEXURE 3
PROFORMA
NAME: / AGE / SEXOP NO: / IP NO: / DOE:
ADDRESS
DIAGNOSIS
DRUG HISTORY
DURATION OF DIABETES
DURATION OF HYPOTHYRIDISM IF PRESENT
SYMPTOM ANALYSIS
SYMPTOMS OF POLYURIAPOLYPHAGIA
POLYDYPSIA
SYMPTOMS OF HYPOTHYROIDISM
SYMPTOMS OF HYPERTHYROIDISM
SYMPTOMS OF DIABETIC COMPLICATIONS
PARAESTHESIA
SYMPTOMS OF ALTERED VISION
SYMPTOMS OF RENAL INVOLVEMENT
CARDIOVASCULAR SYMPTOMS
GENERAL EXAMINATION
HeightWeight
BMI
Pallor
Jaundice
Clubbing
Cyanosis
Lymphadenopathy
Oedema
Pulse
BP
Respiratory System
Cardiovascular System
Abdomen
Neurological System
Signs of Hyperthyrodism
Signs of Hypothyrodism
Fundus Examination
CBC
FBS,PPBS,HbA1C
RFT
Urine routine examination
Fasting Lipid Profile
T3,T4,TSH
ECG
ECHO CARDIOGRAM
NERVE CONDUCTION STUDY-In patients with paresthesia
ANNEXURE 4
CRITERIA FOR THE DIAGNOSIS OF DIABETES MELLITUS (ADA 2011)
1.Symptoms of DM plus random blood glucose more than or equal to 200MG/dl or2. Fasting blood glucose more than or equal to 126mg/dl or
3. HbA1C more than 6.5% or
4. 2hour blood glucose more than or equal to 200mg/dl after glucose tolerance test