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Completed

NCT Number: NCT04876027

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai Tenth People' Hospital

Shanghai, Shanghai Municipality, 200072, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GLP-1 RAs

Drug

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.

Other names: Dulaglutide

Calorie restricted diet

Other

Calorie restricted diet can improve insulin sensitivity, liver fat in patients with visceral obesity, and metabolism and hormone levels in obese women with PCOS.

Primary outcomes

  1. the change in visceral adipose tissue

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

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

Secondary outcomes

  1. menstrual frequency

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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    pituitary prolactin (PRL), mIU/L

  21. total testosterone

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

    total testosterone (TT), ng/ml

  22. free testosterone

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

    free testosterone (FT), pg/ml

  23. Sex hormone binding globulin

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

    Sex hormone binding globulin (SHBG), nmol/L

  24. Androstenedione

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

    Androstenedione (AD), ng/ml

  25. dehydroepiandrosterone sulfate

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

    dehydroepiandrosterone sulfate (DHEAS), ug/dl

  26. controlled attenuation parameter

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

    controlled attenuation parameter (CAP), dB/m

  27. liver stiffness measurement

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

    liver stiffness measurement (LSM), kPa

  28. total body fat

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

    percentage of total body fat, %

  29. total body lean

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

    percentage of total body lean, %

  30. total fat mass

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

    total fat mass, kg

  31. total lean mass

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

    total lean mass, kg

  32. the change in subcutaneous adipose tissue

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

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

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

Dulaglutide and Calorie Restrict Diet (CRD) in Overweight/Obese Patients With Polycystic Ovary Syndrome

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 6, 2021
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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