CANA/Met in Non-diabetic Women With PCOS

Study Overview
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Brief Summary
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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.

Official Title
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Canagliflozin Administration in Non-diabetic Women With Polycystic Ovarian Syndrome

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Canagliflozin combined with metformin
* Drug: metformin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Canagliflozin/metformin group<br>Intervention with canagliflozin combined with metformin for three months | Drug: Canagliflozin combined with metformin<br>* Canagliflozin, a novel glucose-lowering medication, has been shown to have positive effects on reducing body weight, blood pressure and cardiovascular events. Metformin, a classical and common insulin sensitizer that can reduce both hyperinsulinemia and hyperandrogenemia, is widely used for patients with PCOS.<br>|
| Active Comparator: Active Comparator: Metformin group<br>Intervention with metformin for three months | Drug: metformin<br>* Metformin, a classical and common insulin sensitizer that can reduce both hyperinsulinemia and hyperandrogenemia, is widely used for patients with PCOS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index | Changes in body mass index (BMI) | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total testosterone | Changes in total testosterone (TT) | Three months | 
| Androstenedione | Changes in androstenedione (AND) | Three months | 
| Dehydroepiandrosterone sulfate | Changes in dehydroepiandrosterone sulfate (DHEA-S) | Three months | 
| Sex hormone-binding globulin | Changes in sex hormone-binding globulin (SHBG) | Three months |