Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles… (NCT04969627) | Clinical Trial Compass
CompletedPhase 4
Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.
China60 participantsStarted 2021-01-04
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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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