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

• Sponsor: Bing He (Other)
• Overall Status: Completed
• CT.gov ID: NCT04969627
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 4
• Actual Duration (Months): 14.8
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: Metformin; Drug: Exenatide	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.
• Actual Study Start Date: Jan 4, 2021
• Actual Primary Completion Date: Jan 4, 2022
• Actual Study Completion Date: Mar 29, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in body weight [12 weeks]

   Change in body weight

Secondary Outcome Measures

1. Change in body mass index (BMI) [12 weeks]

   Change in body mass index (BMI)

2. Change in waist circumference(WC) [12 weeks]

   Change in waist circumference(WC)

3. 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.

4. 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.

5. Changes in frequency of menstrual cycle [12 weeks]

   Changes in frequency of menstrual cycle

6. 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.

7. Changes in Luteinizing Hormone (LH) [12 weeks]

   Changes in Luteinizing Hormone (LH)

8. Changes in follicle stimulating hormone (FSH) [12 weeks]

   Changes in follicle stimulating hormone (FSH)

9. Changes in LH/FSH [12 weeks]

   Changes in LH/FSH

10. Changes in prolactin (PRL) [12 weeks]

    Changes in prolactin (PRL)

11. Changes in progesterone (Prog) [12 weeks]

    Changes in progesterone (Prog)

12. Changes in total testosterone (TT) [12 weeks]

    Changes in total testosterone (TT)

13. Changes in free testosterone (FT) [12 weeks]

    Changes in free testosterone (FT)

14. Changes in free androgen index (FAI) [12 weeks]

    Changes in free androgen index (FAI)

15. Changes in sex hormone binding globulin (SHBG) [12 weeks]

    Changes in sex hormone binding globulin (SHBG)

16. Changes in dehydroepiandrosterone sulfate (DHEAS) [12 weeks]

    Changes in dehydroepiandrosterone sulfate (DHEAS)

17. Changes in anti-müllerian hormone (AMH) [12 weeks]

    Changes in anti-müllerian hormone (AMH)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shengjing Hospital of China Medical University	Shenyang	Liaoning	China	110004

Sponsors and Collaborators

• Bing He

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bing He, Professor, Shengjing Hospital
• ClinicalTrials.gov Identifier: NCT04969627
• Other Study ID Numbers: 2020PS624K
• First Posted: Jul 21, 2021
• Last Update Posted: Apr 14, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Overweight; Metformin; Exenatide

Study Results

No Results Posted as of Apr 14, 2022