RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA
BANGALORE
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / Name of the Candidate and address(in BLOCK letters) / Dr.KESHAVAMURTHY H R
ROOM NO. 110,
KIMS MENS HOSTEL,
BANASHANKARI 2nd STAGE,
BANGALORE-560070.
2. / Name of the Institution / KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES,
BANASHANKARI 2ND STAGE,
BANGALORE-560070.
3. / Course of study and subject / M. D. BIOCHEMISTRY.
4. / Date of admission to the course / 31st MAY 2012
5. / Title of topic / A STUDY ON SERUM LEPTIN LEVELS AND LIPID PROFILE IN OBESITY.
6.BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the study:
Obesity has reached epidemic proportions in India in the 21st century, with morbid obesity affecting 5% of the country’s population. India is following the trend of other developing countries that are steadily becoming more obese. Indians are genetically susceptible to weight accumulation especially around the waist.
Obesity patients are more prone to develop diseases such as type II diabetes, hyperlipidemia, cholelithiasis, arteriosclerosis, cardio-vascular and cerebro-vascular diseases, certain type of cancer and osteoarthritis. Obesity is associated with an increased risk of morbidity and mortality as well as reduced life expectancy.
The discovery of the adipocyte derived hormone leptin has brought a new perspective to the pathophysiological mechanisms of obesity and associated diseases1. Intial studies on Leptin showed that it regulates apetite and enhances energy expenditure by activating sympathetic nerve activity to thermogenic brown adipose tissue2. However, in common obesity, leptin loses the ability to inhibit energy intake and increase energy expenditure3.
The metabolic defects that ensue in obesity include increased levels of free fatty acids, increased LDL cholesterol, VLDL and triglycerides and decrease in HDL-cholestrol10.
In India very few studies have been conducted to determine serum leptin levels in Indian population. In this background the present study will be conducted to assess Serum leptin levels and Lipid profile in obese and non-obese patients visiting KIMS hospital Bangalore.
6.2 Review of literature:
A pilot study conducted by Mariusz et al. on Serum concentrations of Leptin, Insulin, Adiponectin, resistin and grehlin and their association with obesity indices showed that leptin may be a very important pathogenic factor in patients with severe obesity4.
A study conducted by Masahiro Nishina et al. on Serum Insulin and Leptin and Visceral fat accumulation in obese showed that obesity is strongly associated with Hyperleptinemia and Visceral fat accumulation5.
A study conducted by Vincent T.K Chow et al. on the measurement of Serum Leptin concentrations in university undergraduates by competitive ELISA reveals correlations with BMI and sex 6.
A study conducted by Robert V. Considine et al. on Serum immunoreactive leptin concentrations in normal weight and obese humans suggested that most obese persons are insensitive to endogenous leptin production7.
A study conducted by George Alberti et al. on Serum leptin concentration and obesity suggested an important role for leptin in human metabolism and obesity8.
A study conducted by Lee J H et al. on the association of Leptin resistance in extreme obesity and its aggregation in families, suggests that Leptin resistance appears to be common in the extremely obese but rare in normal weight subjects and plasma leptin concentration aggregated in families9.
A study conducted by Bhatti MS et al on Lipid profile in obesity showed that all the lipid profile parameters except Serum HDL were significantly increased in obese persons11.
A study conducted by Szuzygielska et al. on blood lipid profile in obese or overweight patients showed a linear correlation between the degree of obesity and plasma level of LDL cholesterol and Triglycerides12.
A study conducted by Maksvytis A et al. on impact of obesity on Lipid profile in middle-aged women showed that obesity in middle aged women is associated with a significant decrease in serum HDL13.
6.3 Objectives of the study :
· To estimate Serum Leptin levels in obese and non-obese subjects
· To determine Serum Lipid profile in obese and non-obese subjects
7. MATERIALS AND METHODS:
7.1 Source of data :
7.1 (a) Study Area : The study will be conducted in the outpatient and in patient department of General Medicine in KIMS hospital Bangalore.
7.1 (b) Study subjects : Both male and female subjects in the age group of 18-50 years in the out-patient and inpatient department of General Medicine, KIMS hospital, Bangalore .
7.1 (c) Study Period : Between December 2012 and May 2014
7.1 (d) Sample Design : Purposive Sampling
A. Inclusion criteria:
a) Obese male and female subjects visiting the department of General Medicine in the age group of 18-50 years with BMI of greater than or equal to 30kg/m2 according to WHO criteria.
b) Non-obese male and female subjects visiting the department of General Medicine in the age group of 18-50 years with BMI >18.5 kg/m2 and <25kg/m2.
c) Subjects who are willing to participate in the study
B. Exclusion criteria: :
a) Patients taking systemic drugs especially lipid lowering agents, smoking, alcohol users and other conditions which alter lipid profile.
b) Family history of hyperlipidemia,
c) Subjects with endocrinal disorders,
d) Subjects with psychiatric disorders and pregnancy,
7.2 Method of collection data:
7.2a Method of sample collection:
Following selection of subjects and after obtaining informed written consent about the proposed study, about 5 ml of fasting venous blood will be obtained by venepuncture under aseptic precautions. After centrifugation, serum will be used for estimation of parameters required for the study.
Determination of parameters:
Blood samples will be taken from the subjects by venepuncture. The separated serum will be used for the following tests:
1) Serum Leptin levels are estimated with human Leptin ELISA kit
2) Serum cholesterol is estimated by enzymatic, colorimetric method.
3) Serum Triglyceride is estimated by enzymatic colorimetric test.
4) Serum HDL-Cholesterol estimated by homogenous enzymatic colorimetric test.
5) Serum VLDL-cholesterol is calculated according to the formula VLDL=TG/5.
6) Serum LDL-Cholesterol is estimated by homogenous enzymatic colorimetric assay.
7) Total Cholesterol/HDL-C and LDL-C/HDL-C ratios will be determined.
8) Weight is recorded with standard weighing machine.
9) Height is measured with a standard scale mounted on the wall
10) BMI is calculated by dividing the weight by the square of height
11) Waist circumference will be measured using measuring tape.
7.2b Sample size:
Total number of subjects : 90
Number of obese subjects : 45
Number of non-obese subjects : 45
7.2c Type of study:
Comparitive study.
7.2d Statistical Analysis:
Student’s t-test
7.3 Does the study require any investigations, interventions to be conducted on patients or other humans or animals? If so please describe briefly.
YES.
The study does not include any animal experiments. The following investigations
will be carried out on human blood samples
1. Serum Leptin
2. Serum lipid profile.
7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3?
YES.
8. LIST OF REFERENCES:
- Kamal Rahmouni, Obesity, Sympathetic overdrive, and Hypertension, The Leptin connection. Hypertension. 2010;55:844-845
- Tina A. Dardeno, Sharon H. Chou, Hyun-Seuk Moon, John P. Chamberland, Christina G. Fiorenza, Christos S. Mantzoros , Leptin in Human Physiology and Theurapeutics. Front Neuroendocrinol. 2010;31(3):377-393
- Pablo J. Enriori, Anne E. Evans, Pushpa Sinnayah, and Michael A. Cowley, Leptin Resistance and Obesity. Obesity. 2006; 14: 254-258
- Mariuz Stepien, Rafal N. Wlazel, Marek Paradowski, Maciej Banach, Magdalena Rysz, Malgorzata Misztal, et al, Serum concentrations of Adiponectin, leptin, resistin, ghrelin and Insulin and their association with obesity indices in obese. Arch Med Scl. 2012;8(3):431-436
- Masahiro Nishina, Toru Kikuchi, Hisashi Yamazaki, Kazuhiro Kameda, Makoto Hiura, Makato Uchiyama. Relationship among systolic blood pressure,Serum Insulin and Leptin, and Visceral fat accumulation in obese children. Hypertens Res.2003 Apr;26(4):281-288.
- Vincent T.K Chow, M.C. Phoon, Measurement of serum leptin concentrations in university undergraduates by competitive ELISA reveals correlations with body mass index and sex. Advan in Physiol Edu. 2003;27:70-77
- Robert V. Considine, Madhur K. Sinha, Mark L. Heiman, Aidas Kriauciunas, Thomas W. Stephens, Mark R. Nyce, et al, Serum immunoreactive-Leptin concentrations in Normal weight and obese humans. N Eng J Med. 2000; 334(5):292-295
8. George Alberti, Gary Dowse, Serum leptin concentration, obesity and insulin resistance in western Samoans:cross sectional study. BMJ.1996 October 19;313(7063): 965–969
- Lee JH, Reed DR, Price RA, Leptin resistance is associated with extreme obesity and aggregates in families. International journal of Obesity. 2001;25:1471-1473
- Surajit Kumar Mukhopadhyay, Study of Lipid profile in obese individuals and the effect of cholesterol lowering agents on them. Al Ameen J Med Sci. 2012; 5(2): 147-151
- Bhatti MS, Akbri HZ, Shakoor M, Lipid profile in Obesity. J Ayub Med Coll Abbottabad. 2001; 13(1): 31-33
- Szczygielska A, Widomska S, Jaraszkiewicz M, Knera P. Muck, Blood lipid profile in obese or overweight patients. Ann Univ Mariae Curie Skoldowska Med. 2003; 58(2): 343-349
- Maksvytis A, Stakisaitis D, Impact of obesity on Lipid profiles in middle-aged women. Medicina. 2004;40(6):553-557
9. / Signature of the candidate:
10. / Remarks of the guide : / Obesity has adverse effects on both mortality and morbidity. Very little is known about etiology of obesity. There are probably many different causes of Obesity. However defective Leptin biology is the most important and common cause of Obesity.
11. / Name and Designation of Guide: ( in block letters)
11.1 Guide: / Dr. S SUNITHA M.D.
Associate Professor,
Department of Biochemistry,
KIMS, Bangalore.
11.2 Signature :
11.3 Co-Guide: / Dr. YOGITHA C M.D
Associate Professor
Department of Medicine
KIMS, Bangalore
11.4 Signature:
11.5 Head of the Department: / Dr. B. V. RAVI M.D
Professor and Head
Department of Biochemistry
KIMS, Bangalore
11.6 Signature:
12. / 12.1 Remarks of the chairman
and Principal:
12.2 Signature: