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

Bing He60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in body weight

Time frame: 12 weeks

Secondary Outcomes

Change in body mass index (BMI)

Time frame: 12 weeks

Change in waist circumference(WC)

Time frame: 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.

Time frame: 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.

Time frame: 12 weeks

Changes in frequency of menstrual cycle

Time frame: 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.

Time frame: 12 weeks

Changes in Luteinizing Hormone (LH)

Time frame: 12 weeks

Changes in follicle stimulating hormone (FSH)

Time frame: 12 weeks

Changes in LH/FSH

Time frame: 12 weeks

Changes in prolactin (PRL)

Time frame: 12 weeks

Changes in progesterone (Prog)

Time frame: 12 weeks

Changes in total testosterone (TT)

Time frame: 12 weeks

Changes in free testosterone (FT)

Time frame: 12 weeks

Changes in free androgen index (FAI)

Time frame: 12 weeks

Changes in sex hormone binding globulin (SHBG)

Time frame: 12 weeks

Changes in dehydroepiandrosterone sulfate (DHEAS)

Time frame: 12 weeks

Changes in anti-müllerian hormone (AMH)

Time frame: 12 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes