Health Condition 1: N832- Other and unspecified ovarian cysts
Conditions
Interventions
Intervention1: Dapagliflozin 10 mg once daily orally for 12 weeks: Dapagliflozin 10 mg once daily orally for 12 weeks
Control Intervention1: Metformin 1000-1500 mg daily: Metformin 1000-1500 mg (once
Sponsors
Indian Council of Medical Research (ICMR), New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Females aged 18 to 45 years. 2. Subjects with PCOS diagnosed based on the Rotterdam criteria Or We will modify the criteria as per any modification of criteria by standard guidelines. 3. BMI greater than equal to 23 kgperm2 and Homeostatic model assessment of insulin resistance (HOMA-IR) with a cut-off greater than equal to 2.5. 4. Negative pregnancy test during screening visit and agree to use barrier contraception during the study period. 5. Patients who are willing or able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Congenital adrenal hyperplasia such as 21-hydroxylase deficiency, hyperprolactinemia, Cushing syndrome, androgen-producing tumours of the adrenal gland or ovary. 2. Other endocrine diseases include poorly controlled thyroid diseases (hyperthyroidism or hypothyroidism), acromegaly. 3. Patients with a history of acute or chronic infection, severe cardio-cerebrovascular diseases and acute or chronic pancreatitis. 4. History of recurrent urinary tract infection. 5. History of malignant tumour.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the relationship between heavy metal exposure (e.g., lead, mercury, cadmium, and arsenic) and the development of PCOS in women of reproductive age. To assess the improvement in insulin resistance with dapagliflozin compared to metformin in women with PCOS, as measured by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). Timepoint: HOMA index at end of study, at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the changes in efficacy parameters (Hormone levels - serum free testosterone, sex hormone-binding globulin (SHBG), total testosterone (TT), dehydroepiandrosterone sulfate (DHEAS), androstenedione (AD), and luteinizing hormone (LH) and Follicle Stimulating hormone (FSH) levels, Lipid profile, biochemical parameters (waist circumference, hip circumference, body weight, BMI, Blood Pressure and glucose levels) between the two treatment groups.Timepoint: At end of 12 weeks;2. To assess the safety of dapagliflozin compared to metformin in the treatment of insulin resistance in women with PCOS by evaluating the number of adverse events with grades 3-5 warranting withdrawal of drugs during the treatment period.Timepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactDr Surjit Singh
All India Institute of Medical Sciences Jodhpur
Outcome results
None listed