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. |

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|2. |NAME OF THE INSTITUTION |VYDEHI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTER,BANGALORE. |

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|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. |

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| |Pierre has shown an increasing dose response relationship between alcohol intake levels and multivariate odds ratios of thyroid |

| |enlargement in both males and females5. |

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| |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. |

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| |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. |

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| |Exclusion criteria: |

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| |Patients with Intrinsic Thyroid Disorders and other liver disorders due to any other cause(not caused by alcohol). |

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| |Patients with Hypothalamus and Pituitary gland dysfunction. |

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| |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., |

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| |7.2 b Sample: |

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| |After consulting statistician, sample size is estimated to be 50 cases. |

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| |7.2 c Type of study: |

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| |Observational Prospective Cohort Study |

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| |7.2 d Statistical analysis: |

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| |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. |

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| | |

| |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 |

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| |No interventions are required. |

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| |7.4 Has ethical clearance been obtained from your institution in case of 7.3? |

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| |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. |

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| |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. |

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| |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. |

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| |Yatan Pal Singh Balhara, Koushik Sinha Deb. “Impact of alcohol on thyroid function”. Indian Journal of Endocrine Metabolism |

| |2013;17:580-587 |

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| |Onnie Niemela and Paivikki Alatalo. “Biomarkers of Alcohol consumption and related Liver Disease”.Scandinavian journal of Clinical |

| |and Laboratory Investigations 2010;70:305-312. |

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| 9. |SIGNATURE OF THE CANDIDATE | |

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|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. |

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| |11.2 SIGNATURE | |

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| |11.3 CO-GUIDE | |

| |(if any) | |

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| |11.4 SIGNATURE | |

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| |11.5 HEAD OF THE DEPARTMENT |Dr.RAGHAVENDRA.D.S |

| | |Professor & HOD, |

| | |Department of Biochemistry, |

| | |VIMS & RC, |

| | |Bnagalore-560066 |

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| |11.6 SIGNATURE | |

|12 |REMARKS OF THE CHAIRMAN & | |

| |PRINCIPAL | |

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| |12.1 SIGNATURE | |

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