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CANA/Met in Non-diabetic Women With PCOS

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Canagliflozin combined with metformin
metformin
Sponsored by
Shengjing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Shengjing Hospital of China Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: Canagliflozin/metformin group

Active Comparator: Metformin group

Arm Description

Intervention with canagliflozin combined with metformin for three months

Intervention with metformin for three months

Outcomes

Primary Outcome Measures

Body mass index
Changes in body mass index (BMI)

Secondary Outcome Measures

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

Full Information

First Posted
July 9, 2021
Last Updated
April 13, 2022
Sponsor
Shengjing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04973891
Brief Title
CANA/Met in Non-diabetic Women With PCOS
Official Title
Canagliflozin Administration in Non-diabetic Women With Polycystic Ovarian Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 7, 2021 (Actual)
Primary Completion Date
July 8, 2021 (Actual)
Study Completion Date
March 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Canagliflozin/metformin group
Arm Type
Experimental
Arm Description
Intervention with canagliflozin combined with metformin for three months
Arm Title
Active Comparator: Metformin group
Arm Type
Active Comparator
Arm Description
Intervention with metformin for three months
Intervention Type
Drug
Intervention Name(s)
Canagliflozin combined with metformin
Intervention Description
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
Intervention Name(s)
metformin
Intervention Description
Metformin, a classical and common insulin sensitizer that can reduce both hyperinsulinemia and hyperandrogenemia, is widely used for patients with PCOS.
Primary Outcome Measure Information:
Title
Body mass index
Description
Changes in body mass index (BMI)
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Total testosterone
Description
Changes in total testosterone (TT)
Time Frame
Three months
Title
Androstenedione
Description
Changes in androstenedione (AND)
Time Frame
Three months
Title
Dehydroepiandrosterone sulfate
Description
Changes in dehydroepiandrosterone sulfate (DHEA-S)
Time Frame
Three months
Title
Sex hormone-binding globulin
Description
Changes in sex hormone-binding globulin (SHBG)
Time Frame
Three months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
36147577
Citation
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.
Results Reference
derived

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CANA/Met in Non-diabetic Women With PCOS

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