The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS
Condition: Polycystic Ovary Syndrome (PCOS); Overweight; Obesity
MeSH terms: Polycystic Ovary Syndrome; Overweight; Syndrome
Intervention: Metformin-GLP-1 Receptor Agonist; Metformin-Oral Contraceptive(OC)
Intervention description: metformin oral with exenatide/liraglutide subcutaneous injection.; metformin with Diane 35 oral intake.
Intervention MeSH terms: Metformin; Liraglutide; Exenatide; Contraceptive Agents; Contraceptives, Oral
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Polycystic Ovary Syndrome (PCOS); Overweight; Obesity; GLP-1 Agonist; Oral contraceptives (OCs); Metformin; Reproductive Disorders; Cardiovascular risk factor; Lipid Metabolism

Summary:

      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.
    

Eligibility criteria:

        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.