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SGLT2 Inhibitors in Patients With PCOS (PCOS)

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
SGLT2 inhibitors
Metformin
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovary syndrome (PCOS);, Insulin resistance (IR), Sodium-glucose co-transporter-2 inhibitors (SGLT-2i), Canagliflozin

Eligibility Criteria

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

Inclusion criteria:

  • Fmale aged 18- 45;
  • Meet Rotterdam criteria;
  • Insulin Rsistance

Exclusion Criteria:

  • Women who are pregnant or have a pregnancy plan within six months; ·Congenital adrenocortical hyperplasia;
  • Hyperprolactinemia;
  • Hyperthyroidism or hypothyroidism;
  • 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 contraceptives, metformin, GLP-1RA, SGLT2I, pioglitazone and contraceptives in the last 3 month.

Sites / Locations

  • Shanghai Tenth People' Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SGLT2 inhibitors group

Metformin group

Arm Description

Intervention with SGLT2 inhibitors (100mg/d) for 3 months

Intervention with metformin (1500-2000mg/d) for 3 months

Outcomes

Primary Outcome Measures

HOMA-IR
Homeostatic model assessment insulin resistance index

Secondary Outcome Measures

WHR
Waist/hip Ratio
WC
Waist Circumference (cm）
HC
Hip Circumference（cm）
Menstrual cycles
annual number of menstrual cycles
FBG
fasting blood-glucose in mmol/L
PBG
postprandial blood-glucose in mmol/L
FINS
fasting serum insulin in mU/L
PINS
Postprandial insulin in mU/L
ALT
alanine aminotransferase in U/L
AST
Aspartate aminotransferase in U/L
UA
Uric acid in umol/L
CR
Creatinine in umol/L
LDL-c
low-density lipoprotein cholesterol in mmol/L
HDL-c
high-density lipoprotein cholesterol in mmol/L
TC
Total Cholesterol in mmol/L
TG
Triglyceride in mmol/L
TT
total testosterone in nmol/L
LH
Luteinizing hormone in IU/L
FSH
follicle-stimulating hormone in IU/L）
E2
Estradiol in pmol/L、PRL(Prolactin in uIU/ml)
PRL
Prolactin in uIU/ml
Metabonomics
the change of Metabonomics after the treatment
Ferriman-Gallwey score
Ferriman-Gallwey score、acne, male pattern baldness
acne score
male pattern baldness
male pattern baldness
male pattern baldness
HOMA- ISI
Homeostatic model assessment insulin sensitivity index
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Adverse events and Safety data in two treatment groups.
BMI
body mass index in kg/m^2
SHBG
sex hormone binding globulin in nmol/L
FT
Free testosterone in pg/ml
DHEAS
Dehydroepiandrosterone Sulfate in ug/dl
AD
Androstenedione in ng/ml

Full Information

First Posted
August 5, 2020
Last Updated
September 6, 2022
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04700839
Brief Title
SGLT2 Inhibitors in Patients With PCOS
Acronym
PCOS
Official Title
The Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome: A Randomized, Open Label Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
April 28, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

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

5. Study Description

Brief Summary
Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Metformin has been clarified as an option in patients with PCOS. However, the clinical responses to metformin are limited and different. Sodium glucose co-transporter 2 (SGLT2) inhibitors are novel drugs for the treatment of type 2 diabetes, with weight loss, reducing insulin resistance and cardiovascular benefits. Limited data is available on the efficacy of SGLT2 inhibitors in patients with PCOS.
Detailed Description
This clinical study aims to determine the safety and efficacy of canagliflozin vs metformin in Polycystic Ovary Syndrome (PCOS) patients with insulin resistance (IR). Methods: A single center, prospective, randomized open-label study (ratio 1:1), non-inferiority trial was conducted in the department of endocrinology, Shanghai Tenth People's Hospital between July 2019 and April 2021. PCOS women aged 18-45 years with IR were enrolled and randomly assigned to either canagliflozin 100 mg (n = 33) or metformin 1500-2000 mg (n = 35) daily for 12 weeks. The primary outcome was changes in HOMA-IR after 12 weeks treatment. The secondary outcomes included changes in anthropometric, menstrual frequency, sex hormone and metabolic parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic ovary syndrome (PCOS);, Insulin resistance (IR), Sodium-glucose co-transporter-2 inhibitors (SGLT-2i), Canagliflozin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SGLT2 inhibitors group
Arm Type
Experimental
Arm Description
Intervention with SGLT2 inhibitors (100mg/d) for 3 months
Arm Title
Metformin group
Arm Type
Active Comparator
Arm Description
Intervention with metformin (1500-2000mg/d) for 3 months
Intervention Type
Drug
Intervention Name(s)
SGLT2 inhibitors
Other Intervention Name(s)
Canagliflozin tablets or Glucophage
Intervention Description
Sodium-glucose cotransporters inhibitors (SGLT2i) are novel hypoglycemic drugs with unique hypoglycemic mechanisms, which are completely independent of islet β-cell function or insulin sensitivity. Previous studies have shown that SGLT2i may improve IR by inhibiting glucotoxicity, reducing body weight, reducing inflammation, improving islet β-cell function, and reducing oxidative stress.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin is a classic drug for the treatment of polycystic ovary syndrome, which can improve the degree of insulin resistance in PCOS patients.
Primary Outcome Measure Information:
Title
HOMA-IR
Description
Homeostatic model assessment insulin resistance index
Time Frame
3 months
Secondary Outcome Measure Information:
Title
WHR
Description
Waist/hip Ratio
Time Frame
3 months
Title
WC
Description
Waist Circumference (cm）
Time Frame
3 months
Title
HC
Description
Hip Circumference（cm）
Time Frame
3 months
Title
Menstrual cycles
Description
annual number of menstrual cycles
Time Frame
3 months
Title
FBG
Description
fasting blood-glucose in mmol/L
Time Frame
3 months
Title
PBG
Description
postprandial blood-glucose in mmol/L
Time Frame
3 months
Title
FINS
Description
fasting serum insulin in mU/L
Time Frame
3 months
Title
PINS
Description
Postprandial insulin in mU/L
Time Frame
3 months
Title
ALT
Description
alanine aminotransferase in U/L
Time Frame
3 months
Title
AST
Description
Aspartate aminotransferase in U/L
Time Frame
3 months
Title
UA
Description
Uric acid in umol/L
Time Frame
3 months
Title
CR
Description
Creatinine in umol/L
Time Frame
3 months
Title
LDL-c
Description
low-density lipoprotein cholesterol in mmol/L
Time Frame
3 months
Title
HDL-c
Description
high-density lipoprotein cholesterol in mmol/L
Time Frame
3 months
Title
TC
Description
Total Cholesterol in mmol/L
Time Frame
3 months
Title
TG
Description
Triglyceride in mmol/L
Time Frame
3 months
Title
TT
Description
total testosterone in nmol/L
Time Frame
3 months
Title
LH
Description
Luteinizing hormone in IU/L
Time Frame
3 months
Title
FSH
Description
follicle-stimulating hormone in IU/L）
Time Frame
3 months
Title
E2
Description
Estradiol in pmol/L、PRL(Prolactin in uIU/ml)
Time Frame
3 months
Title
PRL
Description
Prolactin in uIU/ml
Time Frame
3 months
Title
Metabonomics
Description
the change of Metabonomics after the treatment
Time Frame
3 months
Title
Ferriman-Gallwey score
Description
Ferriman-Gallwey score、acne, male pattern baldness
Time Frame
3 months
Title
acne score
Description
male pattern baldness
Time Frame
3 months
Title
male pattern baldness
Description
male pattern baldness
Time Frame
3 months
Title
HOMA- ISI
Description
Homeostatic model assessment insulin sensitivity index
Time Frame
3 months
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Adverse events and Safety data in two treatment groups.
Time Frame
3 months
Title
BMI
Description
body mass index in kg/m^2
Time Frame
3 months
Title
SHBG
Description
sex hormone binding globulin in nmol/L
Time Frame
3 months
Title
FT
Description
Free testosterone in pg/ml
Time Frame
3 months
Title
DHEAS
Description
Dehydroepiandrosterone Sulfate in ug/dl
Time Frame
3 months
Title
AD
Description
Androstenedione in ng/ml
Time Frame
3 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: Fmale aged 18- 45; Meet Rotterdam criteria; Insulin Rsistance Exclusion Criteria: Women who are pregnant or have a pregnancy plan within six months; ·Congenital adrenocortical hyperplasia; Hyperprolactinemia; Hyperthyroidism or hypothyroidism; 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 contraceptives, metformin, GLP-1RA, SGLT2I, pioglitazone and contraceptives in the last 3 month.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shen Qu, Dr
Organizational Affiliation
Shang hai Tenth People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Tenth People' Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30866088
Citation
Javed Z, Papageorgiou M, Deshmukh H, Rigby AS, Qamar U, Abbas J, Khan AY, Kilpatrick ES, Atkin SL, Sathyapalan T. Effects of empagliflozin on metabolic parameters in polycystic ovary syndrome: A randomized controlled study. Clin Endocrinol (Oxf). 2019 Jun;90(6):805-813. doi: 10.1111/cen.13968. Epub 2019 Apr 2.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/34726324/
Description
Efficacy of canagliflozin versus metformin in women with polycystic ovary syndrome: A randomized, open-label, noninferiority trial
URL
https://pubmed.ncbi.nlm.nih.gov/30866088/
Description
Effects of empagliflozin on metabolic parameters in polycystic ovary syndrome: a randomized controlled study

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SGLT2 Inhibitors in Patients With PCOS

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