Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.
- Registration Number
- NCT04969627
- Lead Sponsor
- Bing He
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metformin (BMI≥24) Metformin 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 Combination (BMI<24) Metformin 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 Metformin (BMI<24) Metformin 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 Combination (BMI<24) Exenatide 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 Combination (BMI≥24) Metformin 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 Combination (BMI≥24) Exenatide 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
- Primary Outcome Measures
Name Time Method Change in body weight 12 weeks Change in body weight
- Secondary Outcome Measures
Name Time Method Changes in LH/FSH 12 weeks Changes in LH/FSH
Changes in prolactin (PRL) 12 weeks Changes in prolactin (PRL)
Changes in progesterone (Prog) 12 weeks Changes in progesterone (Prog)
Changes in total testosterone (TT) 12 weeks Changes in total testosterone (TT)
Changes in free testosterone (FT) 12 weeks Changes in free testosterone (FT)
Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT) 12 weeks glucose obtained at 0,30,60 and 120 minutes during the OGTT.
Change in Ferriman-Gallwey score 12 weeks Change in Ferriman-Gallwey score，the range of Ferriman-Gallwey score is 0-9, higher scores mean a worse outcome.
Change in body mass index (BMI) 12 weeks Change in body mass index (BMI)
Change in Acne severity score 12 weeks Change in Acne severity score,the range of acne severity score is 0-9, higher scores mean a worse outcome.
Changes in frequency of menstrual cycle 12 weeks Changes in frequency of menstrual cycle
Changes in Luteinizing Hormone (LH) 12 weeks Changes in Luteinizing Hormone (LH)
Change in waist circumference(WC) 12 weeks Change in waist circumference(WC)
Changes in follicle stimulating hormone (FSH) 12 weeks Changes in follicle stimulating hormone (FSH)
Changes in free androgen index (FAI) 12 weeks Changes in free androgen index (FAI)
Changes in sex hormone binding globulin (SHBG) 12 weeks Changes in sex hormone binding globulin (SHBG)
Changes in dehydroepiandrosterone sulfate (DHEAS) 12 weeks Changes in dehydroepiandrosterone sulfate (DHEAS)
Changes in anti-müllerian hormone (AMH) 12 weeks Changes in anti-müllerian hormone (AMH)
Trial Locations
- Locations (1)
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China