Empagliflozin vs Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome With or Without Comorbidity or Multimorbidity

Study Overview
=================
Brief Summary
-----------------
this is open labelled randomize control trial among women with PCOS. PCOS, an endocrine condition, affects 5%-15% of premenopausal women. PCOS is characterized by atypical menstruation, ovulation difficulties, hyperandrogenemia, insulin resistance, and other metabolic abnormalities. Metformin is now an option for PCOS. The clinical reactions to metformin are limited and varied. Novel SGLT2 inhibitors treat type 2 diabetes with weight loss, insulin resistance reduction, and cardiovascular benefits. There is little evidence on SGLT2 inhibitor effectiveness in PCOS patients.

Official Title
-----------------
Comparing the Effects of Empagliflozin and Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome With or Without Comorbidity or Multimorbidity

Conditions
-----------------
Polycystic Ovary Syndrome, Weight Gain, HbA1c

Intervention / Treatment
-----------------
* Drug: Empagliflozin 10 MG
* Drug: MetFORMIN 500 Mg Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women participants belong to the reproductive age group, i.e., 18 to 45 years will be included in the study. All those women of BMI of greater than 25 kg/m2 will be included in this study Women with a diagnosis of PCOS by using two (hyperandrogenism and oligo-anovulation) out of three (oligo-anovulation, hyperandrogenism and polycystic ovaries) Rotterdam criteria 2 which confirm hyperandrogenism (acne, seborrhea, hair loss on the scalp, increased body or facial hair) on clinical judgement will be included in the study Those who documented and self-reported oligomenorrhea (cycle length greater than 35 days and nine or fewer periods per year) will be included. or Those who report amenorrhea (absence of menses for a period of 3 months) will be inclusion criteria of the study. 6- PCO Women with or without comorbidity or Multimorbidity specifically, Hypothyroidism, Diabetes, Hypertension. - Exclusion Criteria: Women of non-classical 21-hydroxylase deficiency, hyperprolactinemia, Cushing's disease, or androgen- secreting tumors will be streaked from participating. In addition to this, Pregnancy or intent to become pregnant, breastfeeding, documented use of oral hormonal contraceptives and hormone- releasing implants, clomiphene citrate or oestrogen modulators, gonadotropin-releasing hormone (GnRH) modulators and Minoxidil will be excluded. History or presence of malignant neoplasms within the last one years, pancreatitis (acute or chronic) will also be excluded from the study Women with recurrent complaint of urinary tract infection (UTI)will be excluded from the study. -

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empagliflozin 10mg<br>Each participant will receive empagliflozin 10mg daily for 3 months | Drug: Empagliflozin 10 MG<br>* Each participant will receive empagliflozin 10mg daily for 3 months.<br>* Other names: EMPAA 10mg;|
| Active Comparator: Metformin 500mg<br>Each participant will receive metformin 1000mg daily for 3 months | Drug: MetFORMIN 500 Mg Oral Tablet<br>* Each participant will receive metformin 1000mg daily for 3 months.<br>* Other names: Glucophage 500mg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irregular menstruations assessment | Assessment of Irregular menstruation measured by menstruations lasts 2 to 7 days after three months of treatment with either empagliflozin 10mg or metformin 1000mg daily. | Three months treatment with either empagliflozin 10mg or metformin 1000mg daily | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | assessment of change in Body weight in Kg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily | Three months treatment with either empagliflozin 10mg or metformin 1000mg daily | 
| Systolic Blood Pressure (SBP) | assessment of change in SBP in mm/Hg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily | Three months treatment with either empagliflozin 10mg or metformin 1000mg daily | 
| Lipid profile measured through biochemical test | assessment of change in Blood Pressure in mg/dL after three months treatment with either empagliflozin 10mg or metformin 1000mg daily | Three months treatment with either empagliflozin 10mg or metformin 1000mg daily | 
| Hb1c test | assessment of change in Hb1c level in percentage after three months treatment with either empagliflozin 10mg or metformin 1000mg daily | Three months treatment with either empagliflozin 10mg or metformin 1000mg daily | 
| fasting blood-glucose measured through biochemical test | assessment of fasting blood-glucose in mmol/L after three months treatment with either empagliflozin 10mg or metformin 1000mg daily | Three months treatment with either empagliflozin 10mg or metformin 1000mg daily | 
| Diastolic Blood Pressure (DBP) | assessment of change in DBP in mm/Hg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily | Three months treatment with either empagliflozin 10mg or metformin 1000mg daily |