RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. / Name of the Candidateand Address
(in block letters) / Dr. BASAVARAJ S.K.
S/O K.S. SANKADAL
PLOT C-4, SECTOR-20,
NAVANAGAR,
BANGALKOT – 587103.
KARNATAKA.
2. / Name of the Institution / J.J.M. MEDICAL COLLEGE,
DAVANGERE - 577 004. KARNATAKA
3. / Course of study and subject / MEDICAL – POSTGRADUATE DEGREE
M.D. IN GENERAL MEDICINE
4. / Date of Admission to course / 28-05-2013
5. / Title of the Topic / “THE STUDY OF RELATIONSHIP BETWEEN TYPE 2 DIABETES MELLITUS AND THYROID DISORDERS”
6. / Brief Resume of the intended work :
6.1 Need for the study :
Thyroid disorders and diabetes mellitus are the two most common endocrinopathies encountered in practice. Both conditions frequently coexist and the prevalence of thyroid dysfunction in patients with diabetes is higher than in general population1. In patients with type 2 diabetes mellitus the prevalence of hypothyroidism and hyperthyroidism is similar to that of the general population. However, in type 2 diabetic patients, the presence of the highly frequent subclinical forms of hyperthyroidism and hypothyroidism should be ruled out since they may be associated with higher cardiovascular risk2.
It has long been recognized that thyroid hormone have marked effects on glucose homeostasis. Glucose intolerance is associated with hyperthyroidism and most recently it was shown that hypothyroidism is characterized by insulin resistance2. In order to review common pathological mechanisms between diabetes and thyroid dysfunction it has to be acknowledged that thyroid hormones exert profound effects in the regulation of glucose homeostasis which include-modifications of the circulation levels of insulin and counter regulatory hormones, intestinal absorption, hepatic production and peripheral tissue uptake of glucose3.
Hence, thyroid hormones have a large effects in modifying glucose metabolism and as a proof of above said concept most diabetics have to adjust their insulin requirements-when overt thyrotoxicosis or hypothyroidism ensue. Prompt therapeutic intervention of thyroid dysfunction–succeeds–in reverting the metabolic decompensation. However, since diabetes has turned into an epidemic disease the focus is nowadays, directed towards the possible interaction between frequent forms of subclinical thyroid disease and insulin resistance.
Therefore, I intend to take up this study in this part of Karnataka in order to establish the possible relationship between Type 2 diabetes mellitus and thyroid disorders and inturn how thyroid disorders if present, influence the control of type 2 diabetes mellitus and glucose metabolism.
6.2 Review of literature :
A case control study done by Vij V et al., done to know the prevalence of thyroid dysfunction in patients of Type 2 diabetes mellitus – on 80 type 2 diabetic subjects and 80 healthy non-diabetic subjects, revealed 28.75% of patients with abnormal thyroid function and also it justified the view that all type 2 diabetic patients should be screened for thyroid disorders4.
A Study done by Singh G. et al., done to evaluate the prevalence of thyroid dysfunction on 80 type 2 diabetic patients, 30% of patients had abnormal thyroid hormone levels and the level of T3, T4 were significantly lower while level of TSH – was significantly higher in type 2 diabetics as compared to non-diabetics. The study concluded that the prevalence of thyroid dysfunction among type 2 diabetic Punjabi population is very high with subclinical hypothyroidism being more common entity5.
A study done by Pasupathi P et al., to investigate the effect of diabetes mellitus on thyroid hormone levels which was a case-control study consisting 100-diabetics & 100 non diabetics. Out of 100 diabetic patients studied 28% had low plasma thyroid hormone levels, 17% had high thyroid hormone levels and 55% had euthyroid levels. This study has shown a high incidence of abnormal thyroid hormone levels among diabetics and it also demonstrated that detection of abnormal thyroid hormone levels in early stage of diabetes mellitus will help to improve quality of life and for better diabetic control state6.
A study done by Anita Devi M et al., which was a case – control study consisting of total 120 cases out of which 50 were taken as control and 70 were known type 2 diabetic patients. The serum T3 & T4 level of type 2 diabetic patients had significantly reduced as compared to the controls where as TSH level were found high. In this study, type 2 diabetic patients were highly associated with hypothyroidism as compared to controls7.
A study done by Perros P et al., on a randomly selected group of 1310 adult diabetic patients, attending a diabetic out patient clinic revealed annual screening for thyroid disease by estimating serum free thyroxine and TSH concentrations. The overall prevalence of thyroid disease was found to be 13.4% and was highest (31.4%) in type 1 diabetic females and lowest in Type 2 diabetic males (6.9%). Female patients with type 1 diabetes had the highest annual risk of developing thyroid disease (12.3%) but all patient groups (Type 1 & Type 2 diabetic males & females) had a higher incidence of thyroid dysfunction compared to that reported in general population. This study suggests that thyroid function should be screened annually in diabetic patients8.
6.3 Objectives of the study :
· To study the relationship between Type 2 diabetes mellitus and thyroid disorders.
· To know the prevalence of thyroid disorders in Type 2 diabetic patients.
· To estimate the need for annual screening of thyroid profile in Type 2 diabetic patients.
7. / Material and Methods :
7.1 Source of data :
All adults with diagnosis of Type 2 diabetes mellitus-attending to OPD/IPD – in hospitals attached to J.J.M. Medical College, Davangere can be taken as cases in the study.
The non-diabetic volunteers without history of diabetes mellitus whose FPG (Fasting Plasma Glucose) was less than 110mg/dl on two occasions were the control subjects in the study.
7.2. Method of collection of data (including sampling procedure if any):
Randomly selected diabetic patients were subjected to evaluation for thyroid function tests biochemically i.e., they will be screened for thyroid profile (T3, T4& TSH) and also screened for the glycemic status i.e., FPG & HBA1C.The diagnosis of diabetes mellitus was based on the American Diabetic Association criteria for type II diabetes mellitus.
Inclusion criteria :
· All adults with diagnosis of Type 2 diabetes mellitus – are cases
and
· Adult non-diabetic volunteers (healthy) are taken as controls
Exclusion criteria :
· Adults who are previously diagnosed as cases of Type 1 diabetes mellitus
· Adults who are not willing to participate in the study
· Adults who are under intensive care
Sample size and design :
Minimum of 60 cases who are diagnosed (old & new) cases of Type 2 diabetes mellitus and 60 controls who are non-diabetic volunteers (healthy adults) are taken up for the study. However the scope of increasing the number of cases also exists depending upon availability of cases in the study period and appropriate statistical data will be applied as per need of the study.
Method of examination :
Venous blood sample was withdrawn and assayed for thyroid function (T3, T4 & TSH) and for the glycemic status (FPG, HbA1C)
Duration of the study : 2 years
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.
The cases and controls enrolled in the study will be subjected for hematological and biochemical investigations and blood sample will be collected under aseptic precautions.
7.4. Has ethical clearance been obtained from your institution in case of 7.3?
Yes
Ethical clearance has been obtained from research and dissertation committee/ethical committee of the institution for this study.
8. / References :
1. Kadiyala R, Peter R, Okosieme OE. Thyroid dysfunction in patients with diabetes: clinical implications and screening strategies. Int J of Clin Pract 2010;64(8):02-35.
2. Brenta G. Diabetes and thyroid disorders.Br J Diabetes Vasc Dis 2010;10(4):172-177.
3. Brenta G. A view of Diabetes from the Thyroid Corner. Thyroid international 2011;3:03-05
4. Vij V, Chitnis P, Gupta VK. Evaluation of Thyroid Dysfunction among Type II Diabetic patients. Int J Pharm Bio Sci 2012;2(4):150-155.
5. Singh G, Gupta V, Sharma AK, Gupta N. Evaluation of Thyroid Dysfunction Among type 2 diabetic Punjabi Population. Adv Biores 2011;2(2):03-09.
6. Pasupathi P, Bhakthavathsalam G, Saravanan G, Sundaramoorthi R. Screening for Thyroid Dysfunction in the Diabetic/Non-Diabetic Population. Thyroid science 2008:3(8):CLS1-6.
7. Devi AM, Singh LS, Singh NS. Association of Thyroid Disorder in Type 2 diabetic patients. IOSR J of Den and Med Science (IOSR-JDMS) 2013;(3):PP23-24
8. Perros P, McCrimmon RJ, Shaw G, Frier BM. Frequency of thyroid dysfunction in diabetic patients: Value of annual screening. Diabetic Med. 1995;12:622-627.
9. / Signature of candidate
10 / Remarks of the guide / This synopsis has been prepared under my guidance. This study is clinically relevant and is feasible.
11 / Name & Designation of (in block letters)
11.1 Guide
11.2 Signature
11.3 Co-Guide (if any)
11.4 Signature
11.5 Head of the
Department
11.6 Signature / Dr. B.G. KARIBASAPPA M.D.,
Professor,
Department of GENERAL MEDICINE,
J.J.M. Medical College,
DAVANGERE - 577 004.
---
Dr. S.N. VISHWAKUMAR M.D.,
Professor and H.O.D.,
Department of GENERAL MEDICINE
J.J.M. Medical College,
DAVANGERE - 577 004.
12 / Remarks of the
Chairman & Principal
12.2. Signature.
7
Approval of ethics committee
Dr. BASAVARAJ S.K.
POST GRADUATE STUDENT
DEPT. OF GENERAL MEDICINE
J.J.M MEDICAL COLLEGE
DAVANGERE-577004
KARNATAKA
The institutional ethics committee, J.J.M Medical College, Davangere has reviewed and discussed your application to conduct the study/dissertation entitled
TITLE : “THE STUDY OF RELATIONSHIP BETWEEN TYPE 2 DIABETES
MELLITUS AND THYROID DISORDERS”
The following documents were reviewed
1. Trail protocol(including protocol amendments), dated ______version no. (S) ______(not applicable)
2. Patient information sheet and informed consent form(including updates if any) in English and/or vernacular language.(yes) in vernacular language.
3. Investigator’s brochure, dated______,version no. _____(not applicable)
4. Proposed methods for patient accural including advertisement(s)etc. proposed to be used for the purpose(not applicable)
5. Principal investigator’s current CV
6. Insurance policy/compensation for participation and for serious adverse events occurring during the study participation (not application)
7. Investigators undertaking (appendix vii) ( not applicable)
We approved the study to be Conducted in its presented form.
The institutional ethics committee , J.J.M Medical college, Davangere expects to informed about the progress of the study, any SAE occurring in the course of the study, any changes in the protocol and patient information/informed consent and asks to be provided a copy of the final report.
Yours sincerely,
Member secretary, Ethics committee Chairman/ vice Chairman
Ethics Committee