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Completed

NCT Number: NCT04969627

Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.

To study the effects of GLP-1 analogues combined with metformin and metformin on gonadal and metabolic profiles in PCOS patients with BMI ≥ 24 in China. 60 cases of overweight PCOS patients were collected from Shengjing hospital. The intervention period was 3 months after intervention with met or met + GLP-1. To evaluate the improvement of met or met + GLP-1 in the treatment of hyperandremia, glucose metabolism, BMI, waist circumference, menstruation, hairiness and acne in PCOS patients with different BMI.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Females 18 years to 40 years of age Diagnosed as PCOS by the 2003 Rotterdam criteria
  • Overweight/obesity (BMI≥24 kg/m2)
  • No pregnant plan in recent 6 months
  • Written consent for participation in the study

Exclusion criteria

  • type 1 or type 2 diabetes mellitus
  • Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia
  • Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • Serious systemic disease or malignant tumor
  • History of pancreatitis (chronic, acute or recurrent)
  • Body weight change ≥10% at 3 months before treatment
  • Used oral contraceptives or sex hormone drugs in the past 1 month
  • Used oral glucocorticoids in the past 1 month
  • Substance (alcohol or drug) abuse or dependence within 3 months
  • Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (>10g/d)
  • Subjects have a severe systemic disease, such as cardiovascular system, Renal impairment (eGFR<60ml/min/1.73m2)
  • Increase of transaminases up to < 2.5 times of upper limit of normal value
  • Have a history of thromboembolic disease or thrombotic tendency
  • Subjects in pregnant or lactating or within 1 year after delivery
  • Subjects have an allergic history to the drugs used in the study
  • Subjects have participated in other clinical researches of medicine within 1 month prior to randomization
  • Use of metformin, glucagon-like peptide -1 receptor agonists, or weight loss medications (prescription or OTC) within 30 days before screening

Treatment and study plan

metformin

Drug

Use Metformin for 3 months to treat PCOS

exenatide

Drug

Use Exenatide for 3 months to treat PCOS

Primary outcomes

  1. Change in body weight

    Time frame: 12 weeks

    Change in body weight

Secondary outcomes

  1. Change in body mass index (BMI)

    Time frame: 12 weeks

    Change in body mass index (BMI)

  2. Change in waist circumference(WC)

    Time frame: 12 weeks

    Change in waist circumference(WC)

  3. Change in Ferriman-Gallwey score

    Time frame: 12 weeks

    Change in Ferriman-Gallwey score,the range of Ferriman-Gallwey score is 0-9, higher scores mean a worse outcome.

  4. Change in Acne severity score

    Time frame: 12 weeks

    Change in Acne severity score,the range of acne severity score is 0-9, higher scores mean a worse outcome.

  5. Changes in frequency of menstrual cycle

    Time frame: 12 weeks

    Changes in frequency of menstrual cycle

  6. Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT)

    Time frame: 12 weeks

    glucose obtained at 0,30,60 and 120 minutes during the OGTT.

  7. Changes in Luteinizing Hormone (LH)

    Time frame: 12 weeks

    Changes in Luteinizing Hormone (LH)

  8. Changes in follicle stimulating hormone (FSH)

    Time frame: 12 weeks

    Changes in follicle stimulating hormone (FSH)

  9. Changes in LH/FSH

    Time frame: 12 weeks

    Changes in LH/FSH

  10. Changes in prolactin (PRL)

    Time frame: 12 weeks

    Changes in prolactin (PRL)

  11. Changes in progesterone (Prog)

    Time frame: 12 weeks

    Changes in progesterone (Prog)

  12. Changes in total testosterone (TT)

    Time frame: 12 weeks

    Changes in total testosterone (TT)

  13. Changes in free testosterone (FT)

    Time frame: 12 weeks

    Changes in free testosterone (FT)

  14. Changes in free androgen index (FAI)

    Time frame: 12 weeks

    Changes in free androgen index (FAI)

  15. Changes in sex hormone binding globulin (SHBG)

    Time frame: 12 weeks

    Changes in sex hormone binding globulin (SHBG)

  16. Changes in dehydroepiandrosterone sulfate (DHEAS)

    Time frame: 12 weeks

    Changes in dehydroepiandrosterone sulfate (DHEAS)

  17. Changes in anti-müllerian hormone (AMH)

    Time frame: 12 weeks

    Changes in anti-müllerian hormone (AMH)

Sponsors and collaborators

Lead sponsor

Bing He

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2021
Registry last updated
Apr 14, 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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