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

NCT04969627 | Completed Phase 4 DMC

• 1 other identifier: 2020PS624K
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Change in body weight

  12 weeks

Secondary Outcomes (17)

• Change in body mass index (BMI)

  12 weeks

• Change in waist circumference(WC)

  12 weeks

• Change in Ferriman-Gallwey score

  12 weeks

• Change in Acne severity score

  12 weeks

• Changes in frequency of menstrual cycle

  12 weeks

Study Arms (4)

Metformin (BMI<24)

ACTIVE COMPARATOR

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

Metformin (BMI≥24)

EXPERIMENTAL

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

Combination (BMI<24)

EXPERIMENTAL

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; Drug: Exenatide

Combination (BMI≥24)

EXPERIMENTAL

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; Drug: Exenatide

Interventions

Metformin DRUG

Use Metformin for 3 months to treat PCOS

Combination (BMI<24); Combination (BMI≥24); Metformin (BMI<24); Metformin (BMI≥24)

Exenatide DRUG

Use Exenatide for 3 months to treat PCOS

Combination (BMI<24); Combination (BMI≥24)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bing He: lead

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin; Exenatide

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: July 21, 2021
• Study Start: January 4, 2021
• Primary Completion: January 4, 2022
• Study Completion: March 29, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

CN (1)