Clinical trial NCT03151005: The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome (PCOS)
Overweight
Obesity
Keywords: Polycystic Ovary Syndrome (PCOS)
Overweight
Obesity
GLP-1 Agonist
Oral contraceptives (OCs)
Metformin
Reproductive Disorders
Cardiovascular risk factor
Lipid Metabolism
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Assessment of Reproductive Functions
timeFrame: 12 weeks
Secondary outcomes:
measure: Basic Vital Signs
timeFrame: 12 weeks
measure: Assessment of Liver Function
timeFrame: 12 weeks
measure: Assessment of Blood Pressure
timeFrame: 12 weeks
measure: Assessment of Reproductive Function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital, Third Military Medical University
state: Chongqing
Study officials:
affiliation: Department of Endocrinology, Xinqiao Hospital,Third Military Medical University
name: Min long, MD
role: PRINCIPAL_INVESTIGATOR
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