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

Army Medical University of People's Liberation Army

Status and phase: Completed; Phase 4

Conditions: Overweight; Obesity; Polycystic Ovary Syndrome (PCOS)

Treatments: Drug: Metformin-Oral Contraceptive(OC); Drug: Metformin-GLP-1 Receptor Agonist

Study type: Interventional

Funder types: Other

Identifiers

NCT03151005

Xinqiao Endocrinology

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Metformin-GLP-1 Receptor Agonist

Experimental group

Description:

Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks.

Treatment:

Drug: Metformin-GLP-1 Receptor Agonist

Metformin-Oral Contraceptive(OC)

Active Comparator group

Description:

Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks.

Treatment:

Drug: Metformin-Oral Contraceptive(OC)