CANA/Met in Non-diabetic Women With PCOS

Sponsor
Shengjing Hospital
Study ID
NCT04973891
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Polycystic Ovary Syndrome

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Apr 7, 2021
Status verified
Apr 2022
Primary completion
Jul 8, 2021
Completion
Mar 8, 2022

Study Design

Enrollment
52 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Body mass index [ Time Frame: Three months ]

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