Back to resultsEffects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Metformin
Exenatide
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
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
Sites / Locations
- Shengjing Hospital of China Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Metformin (BMI<24)
Metformin (BMI≥24)
Combination (BMI<24)
Combination (BMI≥24)
Arm Description
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
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
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
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
Outcomes
Primary Outcome Measures
Change in body weight
Change in body weight
Secondary Outcome Measures
Change in body mass index (BMI)
Change in body mass index (BMI)
Change in waist circumference(WC)
Change in waist circumference(WC)
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.
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.
Changes in frequency of menstrual cycle
Changes in frequency of menstrual cycle
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.
Changes in Luteinizing Hormone (LH)
Changes in Luteinizing Hormone (LH)
Changes in follicle stimulating hormone (FSH)
Changes in follicle stimulating hormone (FSH)
Changes in LH/FSH
Changes in LH/FSH
Changes in prolactin (PRL)
Changes in prolactin (PRL)
Changes in progesterone (Prog)
Changes in progesterone (Prog)
Changes in total testosterone (TT)
Changes in total testosterone (TT)
Changes in free testosterone (FT)
Changes in free testosterone (FT)
Changes in free androgen index (FAI)
Changes in free androgen index (FAI)
Changes in sex hormone binding globulin (SHBG)
Changes in sex hormone binding globulin (SHBG)
Changes in dehydroepiandrosterone sulfate (DHEAS)
Changes in dehydroepiandrosterone sulfate (DHEAS)
Changes in anti-müllerian hormone (AMH)
Changes in anti-müllerian hormone (AMH)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04969627
Brief Title
Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
January 4, 2022 (Actual)
Study Completion Date
March 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bing He
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin (BMI<24)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Metformin (BMI≥24)
Arm Type
Experimental
Arm Description
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
Arm Title
Combination (BMI<24)
Arm Type
Experimental
Arm Description
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
Arm Title
Combination (BMI≥24)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Use Metformin for 3 months to treat PCOS
Intervention Type
Drug
Intervention Name(s)
Exenatide
Intervention Description
Use Exenatide for 3 months to treat PCOS
Primary Outcome Measure Information:
Title
Change in body weight
Description
Change in body weight
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in body mass index (BMI)
Description
Change in body mass index (BMI)
Time Frame
12 weeks
Title
Change in waist circumference(WC)
Description
Change in waist circumference(WC)
Time Frame
12 weeks
Title
Change in Ferriman-Gallwey score
Description
Change in Ferriman-Gallwey score，the range of Ferriman-Gallwey score is 0-9, higher scores mean a worse outcome.
Time Frame
12 weeks
Title
Change in Acne severity score
Description
Change in Acne severity score,the range of acne severity score is 0-9, higher scores mean a worse outcome.
Time Frame
12 weeks
Title
Changes in frequency of menstrual cycle
Description
Changes in frequency of menstrual cycle
Time Frame
12 weeks
Title
Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT)
Description
glucose obtained at 0,30,60 and 120 minutes during the OGTT.
Time Frame
12 weeks
Title
Changes in Luteinizing Hormone (LH)
Description
Changes in Luteinizing Hormone (LH)
Time Frame
12 weeks
Title
Changes in follicle stimulating hormone (FSH)
Description
Changes in follicle stimulating hormone (FSH)
Time Frame
12 weeks
Title
Changes in LH/FSH
Description
Changes in LH/FSH
Time Frame
12 weeks
Title
Changes in prolactin (PRL)
Description
Changes in prolactin (PRL)
Time Frame
12 weeks
Title
Changes in progesterone (Prog)
Description
Changes in progesterone (Prog)
Time Frame
12 weeks
Title
Changes in total testosterone (TT)
Description
Changes in total testosterone (TT)
Time Frame
12 weeks
Title
Changes in free testosterone (FT)
Description
Changes in free testosterone (FT)
Time Frame
12 weeks
Title
Changes in free androgen index (FAI)
Description
Changes in free androgen index (FAI)
Time Frame
12 weeks
Title
Changes in sex hormone binding globulin (SHBG)
Description
Changes in sex hormone binding globulin (SHBG)
Time Frame
12 weeks
Title
Changes in dehydroepiandrosterone sulfate (DHEAS)
Description
Changes in dehydroepiandrosterone sulfate (DHEAS)
Time Frame
12 weeks
Title
Changes in anti-müllerian hormone (AMH)
Description
Changes in anti-müllerian hormone (AMH)
Time Frame
12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.
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