A clinical trial to compare the efficacy of combination therapy of antidiabetic drugs dapagliflozin & metformin versus metformin alone in improving metabolic profile in overweight & obese women with polycystic ovary syndrome.

Not Applicable

• Conditions: Health Condition 1: E888- Other specified metabolic disordersHealth Condition 2: E66- Overweight and obesity

• Registration Number: CTRI/2023/06/054098
• Lead Sponsor: Dr Vishal Agarwal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Improvement in insulin resistance. <br/ ><br>Change in insulin resistance assessed by insulin sensitivity index- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). <br/ ><br>2.Improvement in free testosterone index. <br/ ><br>3.Change in serum sex hormone binding globulin(SHBG). <br/ ><br>4.Net change in total testosterone (TT) level. <br/ ><br>Timepoint: Baseline <br/ ><br>12 weeks <br/ ><br>24 weeks <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Net change in waist circumference. <br/ ><br>2.Net change in body weight. <br/ ><br>3.Net change in body mass index. <br/ ><br>4.Net change in fasting glucose. <br/ ><br>5.Net change in fasting insulin. <br/ ><br>6.Net change in fasting lipid profile: triglyceride levels, total cholesterol & low density lipoprotein cholesterol levels. <br/ ><br> <br/ ><br>Timepoint: Baseline <br/ ><br>12 weeks <br/ ><br>24 weeks