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

• Status: Unknown status
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xinqiao Hospital of Chongqing
• Collaborators: Azienda Ospedaliera Universitaria Policlinico "G. Martino"; University of Messina
• Treatments: Contraceptive Agents; Contraceptives, Oral; Cyproterone; Cyproterone Acetate; Cyproterone acetate, ethinyl estradiol drug combination; Exenatide; Glucagon; Glucagon-Like Peptide 1; Liraglutide; Metformin

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 14 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.