CANA/Met in Non-diabetic Women With PCOS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-07

Study Completion Date

2022-03-08

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.

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Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental: Canagliflozin/metformin group

Intervention with canagliflozin combined with metformin for three months

Group Type EXPERIMENTAL

Canagliflozin combined with metformin

Intervention Type DRUG

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.

Active Comparator: Metformin group

Intervention with metformin for three months

Group Type ACTIVE_COMPARATOR

metformin

Intervention Type DRUG

Metformin, a classical and common insulin sensitizer that can reduce both hyperinsulinemia and hyperandrogenemia, is widely used for patients with PCOS.

Interventions

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Canagliflozin combined with metformin

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.

Intervention Type DRUG

metformin

Metformin, a classical and common insulin sensitizer that can reduce both hyperinsulinemia and hyperandrogenemia, is widely used for patients with PCOS.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Female aged 18- 45 years old;
2. Diagnosed criteria meet the Rotterdam criteria (2003);
3. Insulin Resistance

Exclusion Criteria

1. Women who are pregnant or have a pregnancy plan within six months;
2. Confirmed diagnosis of diabetes.
3. Congenital adrenocortical hyperplasia;
4. Hyperprolactinemia;
5. Hyperthyroidism or hypothyroidism;
6. Combined with liver or kidney diseases;
7. Abnormal liver function (≥ 3 times of the upper limit of normal range);
8. Abnormal renal function (GFR\<60ml/min/1.73m2);
9. Adrenal or ovarian tumors secreting androgens;
10. Used metformin, glucagon-like peptide-1 receptor agonists, pioglitazone and contraceptives in the last 3 months.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No