Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.

Study Overview
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Brief Summary
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To study the effects of GLP-1 analogues combined with metformin and metformin on gonadal and metabolic profiles in PCOS patients with BMI ≥ 24 in China. 60 cases of overweight PCOS patients were collected from Shengjing hospital. The intervention period was 3 months after intervention with met or met + GLP-1. To evaluate the improvement of met or met + GLP-1 in the treatment of hyperandremia, glucose metabolism, BMI, waist circumference, menstruation, hairiness and acne in PCOS patients with different BMI.

Official Title
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Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Metformin
* Drug: Exenatide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females 18 years to 40 years of age Diagnosed as PCOS by the 2003 Rotterdam criteria Overweight/obesity (BMI≥24 kg/m2) No pregnant plan in recent 6 months Written consent for participation in the study Exclusion Criteria: type 1 or type 2 diabetes mellitus Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Serious systemic disease or malignant tumor History of pancreatitis (chronic, acute or recurrent) Body weight change ≥10% at 3 months before treatment Used oral contraceptives or sex hormone drugs in the past 1 month Used oral glucocorticoids in the past 1 month Substance (alcohol or drug) abuse or dependence within 3 months Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (>10g/d) Subjects have a severe systemic disease, such as cardiovascular system, Renal impairment (eGFR<60ml/min/1.73m2) Increase of transaminases up to < 2.5 times of upper limit of normal value Have a history of thromboembolic disease or thrombotic tendency Subjects in pregnant or lactating or within 1 year after delivery Subjects have an allergic history to the drugs used in the study Subjects have participated in other clinical researches of medicine within 1 month prior to randomization Use of metformin, glucagon-like peptide -1 receptor agonists, or weight loss medications (prescription or OTC) within 30 days before screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin (BMI<24)<br>Subjects: PCOS patients whoseBMI<24 Drug: Glucophage Generic name: Metformin Dosage form: 500mg Dosage: 1500-2000mg/day Frequency: 500mg three times a day/1000mg twice a day Duration: 3 months | Drug: Metformin<br>* Use Metformin for 3 months to treat PCOS<br>|
| Experimental: Metformin (BMI≥24)<br>Subjects: PCOS patients whoseBMI≥24 Drug: Glucophage Generic name: Metformin Dosage form: 500mg Dosage: 1500-2000mg/day Frequency: 500mg three times a day/1000mg twice a day Duration: 3 months | Drug: Metformin<br>* Use Metformin for 3 months to treat PCOS<br>|
| Experimental: Combination (BMI<24)<br>Subjects: PCOS patients whoseBMI<24 Drug: Byetta and Glucophage Generic name: Exenatide Dosage form: Exenatide 5ug and 10ug; Metformin 500mg Dosage: Exenatide10-20ug/day; Metformin 1500-2000mg/day Frequency: Exenatide twice a day; Metformin 500mg three times a day/1000mg twice a day Duration: 3 months | Drug: Metformin<br>* Use Metformin for 3 months to treat PCOS<br>Drug: Exenatide<br>* Use Exenatide for 3 months to treat PCOS<br>|
| Experimental: Combination (BMI≥24)<br>Subjects: PCOS patients whoseBMI≥24 Drug: Byetta and Glucophage Generic name: Exenatide Dosage form: Exenatide 5ug and 10ug; Metformin 500mg Dosage: Exenatide10-20ug/day; Metformin 1500-2000mg/day Frequency: Exenatide twice a day; Metformin 500mg three times a day/1000mg twice a day Duration: 3 months | Drug: Metformin<br>* Use Metformin for 3 months to treat PCOS<br>Drug: Exenatide<br>* Use Exenatide for 3 months to treat PCOS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | Change in body weight | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass index (BMI) | Change in body mass index (BMI) | 12 weeks | 
| Change in waist circumference(WC) | Change in waist circumference(WC) | 12 weeks | 
| Change in Ferriman-Gallwey score | Change in Ferriman-Gallwey score，the range of Ferriman-Gallwey score is 0-9, higher scores mean a worse outcome. | 12 weeks | 
| Change in Acne severity score | Change in Acne severity score,the range of acne severity score is 0-9, higher scores mean a worse outcome. | 12 weeks | 
| Changes in frequency of menstrual cycle | Changes in frequency of menstrual cycle | 12 weeks | 
| Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT) | glucose obtained at 0,30,60 and 120 minutes during the OGTT. | 12 weeks | 
| Changes in Luteinizing Hormone (LH) | Changes in Luteinizing Hormone (LH) | 12 weeks | 
| Changes in follicle stimulating hormone (FSH) | Changes in follicle stimulating hormone (FSH) | 12 weeks | 
| Changes in LH/FSH | Changes in LH/FSH | 12 weeks | 
| Changes in prolactin (PRL) | Changes in prolactin (PRL) | 12 weeks | 
| Changes in progesterone (Prog) | Changes in progesterone (Prog) | 12 weeks | 
| Changes in total testosterone (TT) | Changes in total testosterone (TT) | 12 weeks | 
| Changes in free testosterone (FT) | Changes in free testosterone (FT) | 12 weeks | 
| Changes in free androgen index (FAI) | Changes in free androgen index (FAI) | 12 weeks | 
| Changes in sex hormone binding globulin (SHBG) | Changes in sex hormone binding globulin (SHBG) | 12 weeks | 
| Changes in dehydroepiandrosterone sulfate (DHEAS) | Changes in dehydroepiandrosterone sulfate (DHEAS) | 12 weeks | 
| Changes in anti-müllerian hormone (AMH) | Changes in anti-müllerian hormone (AMH) | 12 weeks |