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TITLE PAGE

THE STUDY OF THE EFFECT OF ANTIDIABETIC DRUGS (METFORMIN AND DIABINESE) ON FEMALE SEX HORMONE IN  TYPE TWO DIABETES MELLITUS PATIENT AT UNIVERSITY OF ILORIN TEACHING HOSPITAL ILORIN, NIGERIA

BY

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EE/H2013/01430
DEPARTMENT OF ----
SCHOOL OF ---
INSTITUTE OF ---

DECEMBER,2018

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APPROVAL PAGE

This is to certify that the research work, "the study of the effect of antidiabetic drugs (metformin and diabinese) on female sex hormone in  type two diabetes mellitus patient at university of ilorin teaching hospital ilorin, nigeria" by ---, Reg. No. EE/H2007/01430 submitted in partial fulfillment of the requirement award of a Higher National Diploma on --- has been approved.

By
---                                                     . ---
Supervisor                                                  Head of Department.
Signature……………….                           Signature……………….        

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External Invigilator

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DEDICATION
This project is dedicated to Almighty God for his protection, kindness, strength over my life throughout the period and also to my --- for his financial support and moral care towards me.Also to my mentor --- for her academic advice she often gives to me. May Almighty God shield them from the peril of this world and bless their entire endeavour Amen.

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ACKNOWLEDGEMENT

The successful completion of this project work could not have been a reality without the encouragement of my --- and other people. My immensely appreciation goes to my humble and able supervisor mr. --- for his kindness in supervising this project.
My warmest gratitude goes to my parents for their moral, spiritual and financial support throughout my study in this institution.
My appreciation goes to some of my lecturers among whom are Mr. ---, and Dr. ---. I also recognize the support of some of the staff of --- among whom are: The General Manager, Deputy General manager, the internal Auditor Mr. --- and the ---. Finally, my appreciation goes to my elder sister ---, my lovely friends mercy ---, ---, --- and many others who were quite helpful.

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Type 2 diabetes mellitus, formerly known as non-insulin dependent diabetes mellitus or adult onset diabetes, is a metabolic disorder that is characterized by hyperglycemia in the context of insulin resistance and relative insulin deficiency The study aims at evaluating the clinical effects of metformin and diabinese on female sex hormone of type 2 diabetes mellitus patients attending University of Ilorin Teaching Hospital (UITH), Ilorin, Kwara State. A total of 100 participants were recruited for this study. Oestrogen and progesterone was analysed using the Enzyme Linked Immunosorbent Assay (ELISA) Technique in Chemical Pathology Laboratory, University of Ilorin Teaching Hospital (UITH), Ilorin, Kwara State using Accu Bind ELISA Microwells. The results of this study depicts significantly (p˂0.05) reduced level of Estrogen (35.59 ±3.99) and Progesterone (0.78 ±0.06 in the diabetic patients using antidiabetic drugs compared with the non-diabetic control patients (58.72±12.31) and 2.49±0.64 respectively). However, the diabetic patients on antidiabetic drugs recorded a significantly (p˂0.05) elevated fasting blood sugar level (9.11±0.39) compared with the non-diabetic control patients (5.07±0.85).The comparison of biochemical parameters (Estrogen, Progesterone and Fasting blood sugar) between diabetic patient using Metformin only and diabetic patients on combined metformin with other drugs (Glimepride) shows an insignificant increase in the level of estrogen (36.15 ±4.33), progesterone (0.78 ±0.61) and fasting blood sugar (9.22 ±0.42) of patients using metformin alone compare with patients using metformin with other drugs (Glimepride) (29.20 ±3.85; 0.78 ±0.167 and 7.86 ±1.16 respectively). The correlation of duration of diabetes and BMI with Biochemical Parameters (estrogen progesterone and fasting blood sugar) in diabetic patients using antidiabetic drugs (metformin and diabinese) indicated a significant correlation between biochemical parameters and duration of illness. Estrogen and duration of diabetes (rValue 0.778; p ˂ 0.037); progesterone (rValue 0.97; p˂0.004) and fasting blood sugar (rValue 0.773; p˂ 0.038). However, data indicated no significant correlation between biochemical parameters and body mass index of the patients. This study concludes that lower level of estrogen and progesterone observed in this study might be attributed to the effect of antidiabetic agents’ metformin and diabenese used by the diabetic patients. This study therefore concludes that antidiabetic drugs have a lowering effect on female sex hormone (estrogen and progesterone). It is therefore recommended that these findings be replicated in a future clinical study and in a larger population to ascertain these facts.

TABLE OF CONTENT
Title page                                                                                                                    i
Certification                                                                                                                ii
Dedication                                                                                                                  iii
Acknowledgement                                                                                                      iv
Table of Content                                                                                                         v
List of figures                                                                                                              vi
List of Tables                                                                                                              vii
Abstract                                                                                                                      viii

CHAPTER ONE
1.0 Introduction                                                                                                          1
1.1Background of study                                                                                             1
1.2Justification for the study                                                                                      3
1.3Aims of the study                                                                                                  3
1.4Specific Objectives of the study                                                                            4
1.5Research hypothesis                                                                                               4
1.6Scope of the study                                                                                                 4
1.7Research design                                                                                                     4

CHAPTER TWO
2.0Literature review                                                                                                    5
2.1Diabetes mellitus                                                                                                    5
2.1.1Types of diabetes                                                                                                6
2.1.1.1Type 16
2.1.1.2Type 26
2.1.1.3Other types....................................................................................................................7
2.1.1.4Gestational diabetes mellitus……................................................................................7
2.1.2Causes of types 2 diabetes...............................................................................................8
2.1.3Signs and symptoms…….................................................................................................8
2.1.4Normal physiology…….....................................................................................................9
2.1.5Pathophysiology………………………….......................................................................10
2.2Treatment of diabetes……………………………………………..……………….........11
2.2.1Oral antidiabetic drugs......................................................................................................11
2.3Metformin hydrochloride……………………………………………………...…...........11
2.3.1Use as first time therapy………………………………………………………….......12
2.3.2Use as combination therapy………………………………………………………….14
2.3.3Adverse effects………………………………………………………………………….15
2.4Diabinese……………………………………………………………………………….....16
2.4.1Clinical pharmacology of diabinese.....................................................................................16.
2.5The female reproductive system.............................................................................................18
2.6Estrogen……………………………………………………………………………….........19
2.6.1Types and example of estrogen..............................................................................................22
2.6.2Biological functions of estrogen............................................................................................23
2.6.3Mode of actions of estrogen..................................................................................................23
2.6.4Biosynthesis of estrogen........................................................................................................24
2.7Progesterone…………………………………………………………………………............25
2.7.1Biosynthesis of progesterone.................................................................................................26
2.7.2Significance of progesterone..................................................................................................27
2.8Estrogen end progesterone regulation.......................................................................................28

Chapter three
3.0Materials and methods.......................................................................................................30
3.1Study area............................................................................................................................30
3.2Sample Size Determination………………………………………………………………30
3.3Inclusion criteria...................................................................................................................30
3.4Exclusion criteria.................................................................................................................30
3.5Sample size determination..................................................................................................30
3.6Method of sample collection………………………………………………………….. 31
3.7Method of sample analysis………………………………………………………………..32
3.7.1Estrogen assay principle.......................................................................................................32
3.7.2Reagent..................................................................................................................................33
3.7.3Reagent preparation............................................................................................................. 34
3.7.4Estrogen assay procedure....................................................................................................  35
3.7.5Determination of progesterone............................................................................................. 35
3.7.6Progesterone assay principle................................................................................................  36
3.7.7Progesterone assay procedure..............................................................................................  37
3.8Calculation of results............................................................................................................... 37
3.8.1 Fasting blood sugar procedure............................................................................................. 38
3.9Statistical Analysis……………………………………………………………………….39

Chapter four
Results......................................................................................................................................40

Chapter five
5.1Discussion...........................................................................................................................50
5.2Conclusion...........................................................................................................................54
5.3Recommendation.................................................................................................................54
References.................................................................................................................................55
Appendix i     Research questionnaire.......................................................................................69
Appendix ii       Reagent composition.......................................................................................71

LIST OF FIGURES
Figure 1: The Female reproductive system……………………………………...
Figure 2:  Chemical structure of estradiol.................................................................             
Figure 3: diagram showing hypothalamic ovarian axis……………………………….         

                                                            LIST OF TABLES
Table 4.1: Comparison of demographic indices between diabetic patients using antidiabetic drugs (metformin and diabinese) and non-diabetic control patients………………….……38

Table 4.2: Comparison Of Anthropometric Indices between diabetic patients using antidiabetic drugs (Metformin and Diabinese (cases) and non-diabetic patients (control)…….............................................................................................................….40

Table 4.3: Comparison of biochemical parameters (estrogen, progesterone and fasting blood Sugar) in diabetes patient using antidiabetic (metformin and diabinese) and non-diabetic patients……………………………………………………….42
Table 4.4: Comparison of biochemical parameters (estrogen, progesterone and fasting blood sugar)between diabetic patients using metformin only and diabetic patients on combined metformin with other drugs.……………………………………….44
Table 4.5: Correlation of duration of diabetes and BMI with biochemical parameters (estrogen progesterone and fasting blood sugar) in diabetic patients using antidiabetic drugs metformin and diabinese)……………………………………………….46

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