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Trial · Interventional

CompletedPhase 4Registry data

GLP-1 RAs in Patients With Polycystic Ovary Syndrome (PCOS)

NCTNCT04876027 (opens ClinicalTrials.gov in a new tab)Other idGLP-1RAs PCOS
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Overview

Status
Completed
Phase
Phase 4
Enrollment
68 participants (actual)
Sponsor
Shanghai 10th People's Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
15 May 2021
Primary completion
30 Apr 2022
Completion
10 May 2022
First posted
6 May 2021
Last update posted
4 Aug 2022
Conditions
Polycystic Ovary Syndrome

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 4

    GLP-1 RAs in Patients With Polycystic Ovary Syndrome (PCOS)

    NCT04876027

    15 May 2021 to 10 May 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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. Visceral fat dysfunction is an important factor in the onset of PCOS. GLP-1 receptor agonist is a glucagon-like peptide 1 analog, which is related to improving blood sugar control, weight loss and appetite suppression, and reducing cardiovascular risk. The purpose of this study was to compare whether the combined treatment of GLP-1 receptor agonists and calorie restrict diet reduced more visceral fat of overweight/obese patients with PCOS at the same weight loss (7%) compared with calorie restrict diet alone.

Interventions

  • GLP-1 RAsDrug
  • calorie restricted dietOther

Arms2

  • Experimental

    GLP-1 RAs and calorie restrict diet group

    Intervention with GLP-1 RAs and calorie restrict diet until reaching the target weight loss(7%)

  • Active comparator

    calorie restrict diet group

    Intervention with calorie restrict diet until reaching the target weight loss(7%)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. the change in visceral adipose tissue

    Time frame · until achievement of the weight loss target,an average of 12 weeks

    Registry description

    the change in visceral adipose tissue (pretreatment-post-treatment) after achievement of the weight loss target

Secondary outcomes(20)

  1. menstrual frequency

    Time frame · from randomization to the time of achievement of the weight loss target, an average of 12 weeks

    Registry description

    number of menstruation in a year

  2. systolic blood pressure

    Time frame · from randomization to the time of achievement of the weight loss target, an average of 12 weeks

    Registry description

    systolic blood pressure (SBP), mmHg

  3. diastolic blood pressure

    Time frame · from randomization to the time of achievement of the weight loss target, an average of 12 weeks

    Registry description

    diastolic blood pressure (DBP), mmHg

  4. fasting plasma glucose

    Time frame · from randomization to the time of achievement of the weight loss target, an average of 12 weeks

    Registry description

    fasting plasma glucose (FPG), mmol/L

  5. postprandial plasma glucose

    Time frame · from randomization to the time of achievement of the weight loss target, an average of 12 weeks

    Registry description

    postprandial plasma glucose (PPG), mmol/L

  6. fasting insulin

    Time frame · from randomization to the time of achievement of the weight loss target, an average of 12 weeks

    Registry description

    fasting insulin (FINS), mU/L

  7. postprandial insulin

    Time frame · from randomization to the time of achievement of the weight loss target, an average of 12 weeks

    Registry description

    postprandial insulin (PINS), mU/L

  8. glycosylated hemoglobin A1c

    Time frame · from randomization to the time of achievement of the weight loss target, an average of 12 weeks

    Registry description

    glycosylated hemoglobin A1c (HbA1c), %

  9. homeostasis model assessment of insulin resistance

    Time frame · from randomization to the time of achievement of the weight loss target, an average of 12 weeks

    Registry description

    homeostasis model assessment of insulin resistance (HOMA-IR)

  10. alanine aminotransferase

    Time frame · from randomization to the time of achievement of the weight loss target, an average of 12 weeks

    Registry description

    alanine aminotransferase (ALT), U/L

  11. aspartate aminotransferase

    Time frame · from randomization to the time of achievement of the weight loss target, an average of 12 weeks

    Registry description

    aspartate aminotransferase (AST), U/L

  12. Total cholesterol

    Time frame · from randomization to the time of achievement of the weight loss target, an average of 12 weeks

    Registry description

    Total cholesterol (TC), mmol/L

  13. Triglycerides

    Time frame · from randomization to the time of achievement of the weight loss target, an average of 12 weeks

    Registry description

    Triglycerides (TG), mmol/L

  14. high-density lipoprotein cholesterol

    Time frame · from randomization to the time of achievement of the weight loss target, an average of 12 weeks

    Registry description

    high-density lipoprotein cholesterol (HDL-c), mmol/L

  15. low-density lipoprotein cholesterol

    Time frame · from randomization to the time of achievement of the weight loss target, an average of 12 weeks

    Registry description

    low-density lipoprotein cholesterol (LDL-c), mmol/L

  16. Creatinine

    Time frame · from randomization to the time of achievement of the weight loss target, an average of 12 weeks

    Registry description

    Creatinine (Cr), umol/L

  17. serum uric acid

    Time frame · from randomization to the time of achievement of the weight loss target, an average of 12 weeks

    Registry description

    serum uric acid (SUA), umol/L

  18. luteinizing hormone

    Time frame · from randomization to the time of achievement of the weight loss target, an average of 12 weeks

    Registry description

    luteinizing hormone (LH), IU/L

  19. follicle-stimulating hormone

    Time frame · from randomization to the time of achievement of the weight loss target, an average of 12 weeks

    Registry description

    follicle-stimulating hormone (FSH), IU/L

  20. pituitary prolactin

    Time frame · from randomization to the time of achievement of the weight loss target, an average of 12 weeks

    Registry description

    pituitary prolactin (PRL), mIU/L

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Female aged 18- 45; * Meet 2003 Rotterdam criteria; * overweight/obesity,BMI≥24kg/m2. Exclusion Criteria: * any contraindication to dulaglutide (known or suspected hypersensitivity to dulaglutide or related products, previous acute pancreatitis or chronic pancreatitis, inflammatory bowel disease; personal history or family history of medullary thyroid carcinoma, or personal history of multiple endocrine neoplasia type 2)； * treatment with any other drugs that may interfere with the trial, including traditional Chinese medicine, contraceptives, metformin, GLP-1RA or pioglitazone within the last 3 months； * chronic kidney disease or severe liver dysfunction； * malignant tumors； * mental illness; * pregnancy or lactation； * inflammatory bowel disease; * recent participation in other weight-loss research projects within the last 3 months.

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