CANA/Met in Non-diabetic Women With PCOS

Sponsor

Shengjing Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04973891

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: Canagliflozin combined with metformin Drug: metformin	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Canagliflozin Administration in Non-diabetic Women With Polycystic Ovarian Syndrome

Actual Study Start Date :

Apr 7, 2021

Actual Primary Completion Date :

Jul 8, 2021

Actual Study Completion Date :

Mar 8, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: Canagliflozin/metformin group Intervention with canagliflozin combined with metformin for three months	Drug: 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.
Active Comparator: Active Comparator: Metformin group Intervention with metformin for three months	Drug: metformin Metformin, a classical and common insulin sensitizer that can reduce both hyperinsulinemia and hyperandrogenemia, is widely used for patients with PCOS.

Arm

Intervention/Treatment

Experimental: Experimental: Canagliflozin/metformin group

Intervention with canagliflozin combined with metformin for three months

Drug: 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.

Active Comparator: Active Comparator: Metformin group

Intervention with metformin for three months

Drug: metformin

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

Outcome Measures

Primary Outcome Measures

Body mass index [Three months]
Changes in body mass index (BMI)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shengjing Hospital of China Medical University	Shenyang	Liaoning	China	110004

Sponsors and Collaborators

Shengjing Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bing He, Professor Bing He, Shengjing Hospital

ClinicalTrials.gov Identifier:

NCT04973891

Other Study ID Numbers:

First Posted:

Jul 22, 2021

Last Update Posted:

Apr 21, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Syndrome

Metformin

Canagliflozin

Study Results

No Results Posted as of Apr 21, 2022