Canagliflozin Administration in Non-diabetic Women With Polycystic Ovarian Syndrome
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Shengjing Hospital
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Body mass index
Study Overview
Brief Summary
Polycystic ovary syndrome (PCOS), which is associated with hyperinsulinaemia, hyperandrogenaemia, impaired glucose metabolism and aberrant adipokines production from the adipose tissue, is a heterogeneous reproductive and endocrine disorder.Currently, metformin, a classical and common insulin sensitizer that can reduce both hyperinsulinemia and hyperandrogenemia, is widely used for patients with PCOS. SGLT-2 inhibitor, a novel glucose-lowering medication, have been shown to have positive effects on reducing body weight, blood pressure and cardiovascular events in individuals with diabetes mellitus. However, evidences related to its management in non-diabetic PCOS women are limited. Hence, we want to give canangliflozin combined with metformin to women with PCOS to see its effect on insulin resistance.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female aged 18- 45 years old;
- •Diagnosed criteria meet the Rotterdam criteria (2003);
- •Insulin Resistance
Exclusion Criteria
- •Women who are pregnant or have a pregnancy plan within six months;
- •Confirmed diagnosis of diabetes.
- •Congenital adrenocortical hyperplasia;
- •Hyperprolactinemia;
- •Hyperthyroidism or hypothyroidism;
- •Combined with liver or kidney diseases;
- •Abnormal liver function (≥ 3 times of the upper limit of normal range);
- •Abnormal renal function (GFR<60ml/min/1.73m2);
- •Adrenal or ovarian tumors secreting androgens;
- •Used metformin, glucagon-like peptide-1 receptor agonists, pioglitazone and contraceptives in the last 3 months.
Arms & Interventions
Experimental: Canagliflozin/metformin group
Intervention with canagliflozin combined with metformin for three months
Intervention: Canagliflozin combined with metformin (Drug)
Active Comparator: Metformin group
Intervention with metformin for three months
Intervention: metformin (Drug)
Outcomes
Primary Outcomes
Body mass index
Time Frame: Three months
Changes in body mass index (BMI)
Secondary Outcomes
- Dehydroepiandrosterone sulfate(Three months)
- Sex hormone-binding globulin(Three months)
- Androstenedione(Three months)
- Total testosterone(Three months)
Investigators
Bing He
Professor Bing He
Shengjing Hospital