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

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Drug: Metformin; Drug: Exenatide

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Females 18 years to 40 years of age Diagnosed as PCOS by the 2003 Rotterdam criteria
2. Overweight/obesity (BMI≥24 kg/m2)
3. No pregnant plan in recent 6 months
4. Written consent for participation in the study

Exclusion Criteria:

1. type 1 or type 2 diabetes mellitus
2. Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia
3. Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
4. Serious systemic disease or malignant tumor
5. History of pancreatitis (chronic, acute or recurrent)
6. Body weight change ≥10% at 3 months before treatment
7. Used oral contraceptives or sex hormone drugs in the past 1 month
8. Used oral glucocorticoids in the past 1 month
9. Substance (alcohol or drug) abuse or dependence within 3 months
10. Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (>10g/d)
11. Subjects have a severe systemic disease, such as cardiovascular system, Renal impairment (eGFR<60ml/min/1.73m2)
12. Increase of transaminases up to < 2.5 times of upper limit of normal value
13. Have a history of thromboembolic disease or thrombotic tendency
14. Subjects in pregnant or lactating or within 1 year after delivery
15. Subjects have an allergic history to the drugs used in the study
16. Subjects have participated in other clinical researches of medicine within 1 month prior to randomization
17. Use of metformin, glucagon-like peptide -1 receptor agonists, or weight loss medications (prescription or OTC) within 30 days before screening

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metformin (BMI<24); 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; Use Metformin for 3 months to treat PCOS
Experimental: Metformin (BMI≥24); 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; Use Metformin for 3 months to treat PCOS
Experimental: Combination (BMI<24); 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; Use Metformin for 3 months to treat PCOS; Drug: Exenatide; Use Exenatide for 3 months to treat PCOS
Experimental: Combination (BMI≥24); 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; Use Metformin for 3 months to treat PCOS; Drug: Exenatide; Use Exenatide for 3 months to treat PCOS

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bing He

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): January 4, 2022
• Study Completion (Actual): March 29, 2022

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: July 17, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Body Weight; Polycystic Ovary Syndrome; Overweight; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Incretins; Metformin; Exenatide
• Other Study ID Numbers: 2020PS624K

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No