CANA/Met in Non-diabetic Women With PCOS

Sponsor
Shengjing Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04973891
Collaborator
(none)
52
1
2
11
4.7

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
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.

Outcome Measures

Primary Outcome Measures

  1. Body mass index [Three months]

    Changes in body mass index (BMI)

Secondary Outcome Measures

  1. Total testosterone [Three months]

    Changes in total testosterone (TT)

  2. Androstenedione [Three months]

    Changes in androstenedione (AND)

  3. Dehydroepiandrosterone sulfate [Three months]

    Changes in dehydroepiandrosterone sulfate (DHEA-S)

  4. 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:
No
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.

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:
  • 777
First Posted:
Jul 22, 2021
Last Update Posted:
Apr 21, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2022