CANA/Met in Non-diabetic Women With PCOS

NCT04973891 | Completed Phase 1

• 1 other identifier: 777
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• Body mass index

  Changes in body mass index (BMI)

  Three months

Secondary Outcomes (4)

• Total testosterone

  Three months

• Androstenedione

  Three months

• Dehydroepiandrosterone sulfate

  Three months

• Sex hormone-binding globulin

  Three months

Study Arms (2)

Experimental: Canagliflozin/metformin group

EXPERIMENTAL

Intervention with canagliflozin combined with metformin for three months

Drug: Canagliflozin combined with metformin

Active Comparator: Metformin group

ACTIVE COMPARATOR

Intervention with metformin for three months

Drug: metformin

Interventions

Canagliflozin combined with metformin 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.

Experimental: Canagliflozin/metformin group

metformin DRUG

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female aged 18- 45 years old;
• Diagnosed criteria meet the Rotterdam criteria (2003);
• Insulin Resistance

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

Related Publications (1)

• Zhang J, Xing C, Cheng X, He B. Canagliflozin combined with metformin versus metformin monotherapy for endocrine and metabolic profiles in overweight and obese women with polycystic ovary syndrome: A single-center, open-labeled prospective randomized controlled trial. Front Endocrinol (Lausanne). 2022 Sep 6;13:1003238. doi: 10.3389/fendo.2022.1003238. eCollection 2022.

  PMID: 36147577 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Bing He

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 22, 2021
• Study Start: April 7, 2021
• Primary Completion: July 8, 2021
• Study Completion: March 8, 2022
• Last Updated: April 21, 2022

Record last verified: 2022-04

Locations

CN (1)