Need for the study
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS
FOR DISSERTATION
|1. |NAME OF THE CANDIDATE |DR JASWANTH KUMAR PAPINENI |
| |AND ADDRESS | |
| |(in block letters) |ROOM NO 10,SECOND FLOOR,BOYS HOSTEL-2,VYDEHI INSTITUTE OF MEDICAL SCIENCES |
| | |AND RESEARCH CENTER,82,EPIP AREA,NALLURAHALLI,WHITEFIELD, |
| | |BANGALORE-560066. |
| | | |
|2. |NAME OF THE INSTITUTION |VYDEHI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTER,BANGALORE. |
| | | |
|3. |COURSE OF STUDY AND SUBJECT |M.D. BIOCHEMISTRY |
|4. |DATE OF ADMISSION TO COURSE |13/07/2013 |
| | |“STUDY OF THYROID HORMONE LEVELS IN CHRONIC ALCOHOLIC LIVER DISEASE |
|5. |TITLE OF THE TOPIC |PATIENTS BEFORE AND AFTER TREATMENT.” |
|6. |BRIEF RESUME OF THE INTENDED WORK : |
| |6.1 Need for the study : |
| |Alcohol is the world’s third largest risk factor for disease and disability, causing atleast 60 types of diseases and contributing |
| |to 200 others. In view of magnitude of the problem, it becomes necessary for us to understand the effect of alcohol on various body |
| |systems and need to implement a prompt way to treat the patients accordingly. |
| |Thyroid hormone levels are altered in chronic alcoholic liver disease. Alcoholic liver disease affects almost all aspects of the |
| |thyroid gland including the thyroid hormone levels and the thyroid gland size. |
| |Alcohol causes direct cellular toxicity on thyroid cells and in chronic alcoholic liver disease, due to continued toxicity on |
| |thyroid cells for a long time, thyroid volume is reduced. |
| |In addition to alcohol related diseases, acute alcohol withdrawal or long term abstinence periods after alcohol dependance has been |
| |reported to reduce peripheral thyroid hormone levels. Furthermore a decrease in free thyroid hormone levels may be a result of heavy|
| |alcohol consumption or a marker of alcoholism. |
| |The altered thyroid hormone levels in alcoholic liver disease may affect alcohol abstinence in withdrawal period by changing hormone|
| |milieu in brain, increasing withdrawal dysphoria and increasing craving. At present such studies are few, but it creates possibility|
| |of understanding and treating alcoholic liver disorders from a whole new perspective. Hence, this study will be undertaken to know |
| |whether thyroid hormone levels could be used as markers of alcoholic liver disease. |
| |6.2 Review of literature : |
| |Miau ju huang has suggested to measure free thyroxine(fT4) and thyroid stimulating hormone (TSH) which are usually normal in |
| |euthyroid patients with liver disease, to rule out or rule in coexistent thyroid functions1. |
| | |
| |Tas A Koklu has shown that measurement of free T3 and free T4 levels may be useful as predictors of mortality in intensive care |
| |patients who have cirrhosis, along with calculation of APACHE 2 (Acute Physiology And Chronic Health Evaluation 2), MELD (Model for |
| |End stage Liver Disease), CTP(Child-Turcotte-Pugh score) and SOFA (Sequential Organ Failure Assessment) scores2. Moustafa AH has |
| |shown that the measurement of T3 levels along with Nitric Oxide, malondialdehyde, reduced Glutathione and Glutathione peroxidase as |
| |biomarkers of liver disease might be a beneficial tool, helping in monitoring the state of liver disease patients3. |
| |Seyed Mohsen has shown that decrease in T3 and T4 levels are associated with the severity of liver disease, and these hormones could|
| |be used as disease prognostic factors. Owing to more severe and more advanced hepatic disorders, patients with low T3 and T4 levels |
| |need a liver transplant more immediately than do other patients4. |
| | |
| |Pierre has shown an increasing dose response relationship between alcohol intake levels and multivariate odds ratios of thyroid |
| |enlargement in both males and females5. |
| | |
| |Yatan Pal, regarding the impact of alcohol on thyroid function, stated that there is a moderate suppression of T4 and significant |
| |suppression of T3 in alcoholics and there is TRH response abnormality and TSH blunting6. |
| | |
| |Onnie Niemela has shown that liver enzymes such as Alanine Transaminase, Aspartate Transaminase and Gamma Glutamyl Transferase are |
| |important screening tools for detecting liver disorders7. |
| |Overall, alcohol affects thyroid hormone levels, liver disorders may affect thyroid hormone levels and altogether Alcoholic Liver |
| |Disease has a greater impact on thyroid hormone levels. |
| | |
| | |
| |6.3 Objectives of the study : |
| |To assess the levels of thyroid hormones- free T3, free T4, TSH and Gamma Glutamyl Transferase in Chronic Alcoholic Liver Disease |
| |patients at the time of admission and at the time of discharge after atleast ten days of treatment. |
| | |
| |To evaluate whether there is any correlation between thyroid hormone levels and Serum Gamma Glutamyl Transferase activity at the |
| |time of admission and at the time of discharge after atleast ten days of treatment. |
| | |
| |To compare thyroid hormone levels- free T3, free T4 and TSH at the time of admission and at the time of discharge after atleast ten |
| |days of treatment. |
| 7. |MATERIALS AND METHODS |
| |7.1. Source of data |
| |50 male patients in the age group of 30-60 years who are chronic alcoholics with regular alcohol intake of more than 60-80gms for |
| |the past 10 years and having alcoholic dependance symptoms and admitted in Department of General Medicine, VIMS&RC, Bangalore. |
| |Duration of the study is one year. |
| | |
| |7.2. Method of data collection: |
| |7.2 a Method of sample collection: |
| | |
| |Under aseptic conditions, venous blood sample of about 5ml will be collected by venepuncture and will be used for the assessment of |
| |the freeT3, freeT4,TSH and GGT at the time of admission and also at the time of discharge after atleast ten days of treatment. |
| |Treatment mainly consists of abstinence from alcohol and supplements like B complex and folic acid and livopill as liver |
| |supplemental drug for a period of atleast ten days and may be for a longer duration depending upon the condition of the patient. |
| |Informed consent will be taken from the patients for the study with the following inclusion and exclusion criteria. |
| |Inclusion criteria: |
| | |
| |Chronic alcoholic male patients in the age group of 30-60 years with history of alcohol intake of more than 60-80gms regularly for |
| |the past ten years. |
| | |
| |Exclusion criteria: |
| | |
| |Patients with Intrinsic Thyroid Disorders and other liver disorders due to any other cause(not caused by alcohol). |
| | |
| |Patients with Hypothalamus and Pituitary gland dysfunction. |
| | |
| |Patients on drugs that affect thyroid hormone levels such as inorganic iodine, iodide, amiodarone, cyanates, lithium, |
| |radiocontrast material containing iodine, tyrosine kinase inhibitors, interferon alpha, interleukin 2 etc., |
| | |
| | |
| | |
| |7.2 b Sample: |
| | |
| |After consulting statistician, sample size is estimated to be 50 cases. |
| | |
| |7.2 c Type of study: |
| | |
| |Observational Prospective Cohort Study |
| | |
| |7.2 d Statistical analysis: |
| | |
| |Pearson correlation- To correlate between thyroid hormone levels and GGT at the time of admission and at the time of discharge. |
| |Paired t test- To compare thyroid hormone levels at the time of admission and at the time of discharge. |
| | |
| | |
| |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, following investigations are required to be performed, which are non invasive. |
| |Free T3 by competitive binding immunoenzymatic assay. |
| |Free T4 by two step enzyme immunoassay. |
| |TSH by two site immunoenzymatic(sandwich) assay. |
| |GGT by enzymatic rate method |
| | |
| |No interventions are required. |
| | |
| | |
| | |
| |7.4 Has ethical clearance been obtained from your institution in case of 7.3? |
| | |
| |Yes. The certificate has been enclosed. |
|8. |LIST OF REFERENCES : |
| | |
| |Miau-ju huang, Yun-fan liaw. “Clinical associations between liver and thyroid |
| |Disorders”.Journal of Gastroenterology and Hepatology 2008;10:344-350 |
| | |
| |Tas A,Koklu S, Beyazit Y, Kurt M et al. “Thyroid hormones predict mortality in intensive care patients with cirrhosis”. American |
| |Journal of Medical Science 2012.;344(3):175-179. |
| | |
| |Moustafa AH, Ali EM, Mohammad TM, Abdou HI. “Oxidative stress and thyroid |
| |Hormones in patients with liver diseases”. European Journal of Internal Medicine 2009;20(7):703-8. |
| | |
| |Seyed Mohsen Dehghani, Mohammad Haghighat, Fatemeh Eghball et al., “Thyroid hormone levels in children with liver cirrhosis |
| |awaiting a liver transplantation”. Experimental and Clinical Transplantation 2013;11:150-153. |
| | |
| |Pierre Valeix, Patrice Faure, Sandrine Bertrais et al. “Effects of light to moderate alcohol consumption on thyroid volume and |
| |thyroid function”. Clinical Endocrinology 2007; 68:988-995. |
| | |
| | |
| |Yatan Pal Singh Balhara, Koushik Sinha Deb. “Impact of alcohol on thyroid function”. Indian Journal of Endocrine Metabolism |
| |2013;17:580-587 |
| | |
| | |
| | |
| |Onnie Niemela and Paivikki Alatalo. “Biomarkers of Alcohol consumption and related Liver Disease”.Scandinavian journal of Clinical |
| |and Laboratory Investigations 2010;70:305-312. |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| 9. |SIGNATURE OF THE CANDIDATE | |
| | | |
|10 |REMARKS OF THE GUIDE |A Good Study. |
| | |Recommended and Forwarded. |
|11 |NAME & DESIGNATION. | |
| | |Dr.RAGHAVENDRA.D.S |
| |11.1 GUIDE |Professor & HOD, |
| | |Department of Biochemistry, |
| | |VIMS & RC, |
| | |Bnagalore-560066. |
| | | |
| |11.2 SIGNATURE | |
| | | |
| |11.3 CO-GUIDE | |
| |(if any) | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| |11.4 SIGNATURE | |
| | | |
| |11.5 HEAD OF THE DEPARTMENT |Dr.RAGHAVENDRA.D.S |
| | |Professor & HOD, |
| | |Department of Biochemistry, |
| | |VIMS & RC, |
| | |Bnagalore-560066 |
| | | |
| | | |
| | | |
| |11.6 SIGNATURE | |
|12 |REMARKS OF THE CHAIRMAN & | |
| |PRINCIPAL | |
| | | |
| | | |
| | | |
| |12.1 SIGNATURE | |
................
................
In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.
Related searches
- the need for education
- the need for education reform
- the need for technology
- the need for nursing research
- bible study for the elderly printable
- the need for human interaction
- the 5 years before you retire retirement planning when you need it the most
- best way to study for the gmat
- study for the gmat
- study questions for the outsiders
- how to study for the gmat
- study guide for the book of john