CTRI/2023/06/054098
Not Yet Recruiting
N/A
Efficacy of treatment with combination dapagliflozin & metformin versus metformin alone in improving insulin resistance and hyperandrogenemia in overweight and obese women with polycystic ovary syndrome.
Dr Vishal Agarwal0 sites0 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Health Condition 1: E888- Other specified metabolic disordersHealth Condition 2: E66- Overweight and obesity
- Sponsor
- Dr Vishal Agarwal
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Body mass index (BMI) more than or equal to 23 kg/m2 2\)PCOS diagnosis by Rotterdam 2003 criteria 3\)No pregnancy plans within next 6 months
Exclusion Criteria
- •1\)Women who are pregnant or plan to become pregnant 2\)Serious liver dysfunction or chronic kidney disease (AST or ALT \> 3 times the upper limit of normal, or eGFR \<30 ml/min/1\.73 m2\) 3\)Congenital adrenal hyperplasia such as 21\-hydroxylase deficiency, hyperprolactinemia, Cushing syndrome, androgen\-producing tumors of the adrenal gland or ovary 4\)Other endocrine diseases include poorly controlled thyroid diseases (hyperthyroidism or hypothyroidism), acromegaly, type 2 diabetes 5\)Patients taking any medication that would affect insulin resistance or hyperandrogenemia (i.e. Thiazolidinediones, Glucagon like peptide\-1 Receptor agonists, Metformin) in the past six weeks 6\)Patients taking letrozole, clomiphene, oral contraceptive, glucocorticoid, gonadotropin, gonadotropin releasing hormone agonist, anti\-androgen drug (spironolactone, cycloproterenone acetate, Flutamide etc.) and/or other drugs for PCOS in the past three months 7\)History of recurrent urinary tract infection 8\)Currently participating in weight loss programs or weight change in the past 3 months ( \> 5% current body weight) or have a history of gastrointestinal surgery.
Outcomes
Primary Outcomes
Not specified
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