CANA/Met in Non-diabetic Women With PCOS

Phase 1

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Canagliflozin combined with metformin; Drug: metformin

• Registration Number: NCT04973891
• Lead Sponsor: Shengjing Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-07
• Primary Completion: 2021-07-08
• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-16
• Study First Posted: 2021-07-22
• Study Completion: 2022-03-08
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Canagliflozin/metformin group	Canagliflozin combined with metformin	Intervention with canagliflozin combined with metformin for three months
Active Comparator: Metformin group	metformin	Intervention with metformin for three months

Primary Outcome Measures

Name	Time	Method
Body mass index	Three months	Changes in body mass index (BMI)

Secondary Outcome Measures

Name	Time	Method
Dehydroepiandrosterone sulfate	Three months	Changes in dehydroepiandrosterone sulfate (DHEA-S)
Sex hormone-binding globulin	Three months	Changes in sex hormone-binding globulin (SHBG)
Total testosterone	Three months	Changes in total testosterone (TT)
Androstenedione	Three months	Changes in androstenedione (AND)

Trial Locations

Locations (1)

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China