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Completed

NCT Number: NCT03151005

The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS

Polycystic ovary syndrome (PCOS) is a health problem that affects one in 10 women of childbearing age, which is usually characterized by hormonal imbalance and metabolism problems such as hyperandrogenism and obesity. Diane 35 pills are classified as oral contraceptives, which effectively reduces circulating androgens and are treatment for hyperandrogenism caused androgenic skin symptoms and irregular menstrual cycles. GLP-1 Receptor Agonist(e.g. exenatide, liraglutide) have the effects of lowering blood sugar and weight control by inhibiting of gastric emptying and reducing food intake. This study aims to evaluate the effect of metformin-GLP-1 Receptor agonist combination versus metformin-Diane-35 combination treatment on lipid metabolism and cardiovascular risks in overweight polycystic ovarian syndrome (PCOS) patients.

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Key information

About this study

Groups:

Experimental treatment: Metformin-GLP-1 Receptor Agonist Therapy.

Regular treatment: Metformin-Oral Contraceptive(OC) Therapy.

Time Point:

Initial treatment;

Post-treatment (4w);

Post-treatment (8w);

Post-treatment (12w);

Assess reproductive functions and cardiovascular risk factors.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of PCOS according to the Rotterdam criteria based on the presence of two of three criteria: oligomenorrhoea, clinical or biochemical hyperandrogenism and polycystic ovaries on ultrasound after exclusion of other endocrine causes of hyperandrogenism.
  • Participants had no concurrent illness and were not on any prescription or over-the-counter medication that was likely to affect insulin sensitivity or lipids for the preceding 12 weeks.
  • Participants were advised not to change physical activity or dietary habits during the study period. All subjects were overweight/obese [body mass index (BMI) >=24 kg/m2 or waistline>=85cm ].
  • All subjects had normal thyroid-stimulating hormone and prolactin levels.

Exclusion criteria

  • smoking, alcohol use, or having taken medication within 2 months of the study that is known to affect reproductive or metabolic functions.
  • age below 18 yr or over 50 yr.
  • postmenopausal.
  • uncontrolled hypertension (blood pressure >=160/100 mm Hg).
  • preexisting OPs or GLP-1 agonists supplementation
  • alcohol intake greater than 20 g/d, or pregnancy.
  • signs of liver or renal failure or active liver disease (ALT > 2.5× the upper limit of normal values).
  • PLT<60*10^9/L,Hb<100g/L, smoking, alcohol use.
  • The patient that cannot complete the intervention or have other conditions that is not appropriate to enter the group, such as patients who are taking glucocorticoid steroids or malignant tumor treatment, etc.

Treatment and study plan

Metformin-GLP-1 Receptor Agonist

Drug

metformin oral with exenatide/liraglutide subcutaneous injection.

Other names: Metformin-exenatide/liraglutide Therapy

Metformin-Oral Contraceptive(OC)

Drug

metformin with Diane 35 oral intake.

Other names: Metformin, Diane 35

Primary outcomes

  1. Assessment of Reproductive Functions

    Time frame: 12 weeks

    Concentration of LH was measured in mIU/ml.

Secondary outcomes

  1. Basic Vital Signs

    Time frame: 12 weeks

    Weight and height will be combined to report BMI in kg/m^2.

  2. Assessment of Liver Function

    Time frame: 12 weeks

    Alanine transaminase was measured in IU/L.

  3. Assessment of Blood Pressure

    Time frame: 12 weeks

    Systolic blood pressure was measured in mmHg.

  4. Assessment of Reproductive Function

    Time frame: 12 weeks

    Changes in testosterone levels were measured

Sponsors and collaborators

Lead sponsor

Xinqiao Hospital of Chongqing

Other

Registry information

Official study title

Randomized Clinical Trial to Evaluate The Effect of Metformin-GLP-1 Receptor Agonist Versus Oral Contraceptive (OC) Therapy on Reproductive Disorders and Cardiovascular Risks in Overweight Polycystic Ovarian Syndrome (PCOS) Patients

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 12, 2017
Registry last updated
Dec 4, 2023

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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