In PCOS (Polycystic Ovary Syndrome), studies have found impaired incretin secretion and activity, particularly in overweight/obese individuals. Conflicting results exist regarding glucagon-like peptide-1(GLP-1) levels in PCOS patients, with studies reporting reduced, normal, or increased levels. Incretin-based therapy has been suggested as a potential treatment to reverse prediabetes risk by preserving β-cell function in patients with impaired fasting glucose(IFG and impaired glucose tolerance(IGT). The study aims to compare the efficacy of Dapagliflozin to Metformin for the treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).
Incretins such as glucagon-like peptide-1(GLP-1) are gut hormones secreted after meals that enhance insulin secretion and help maintain glucose homeostasis.They also reduce hepatic glucagon release, slow gastric emptying, and suppress appetite, aiding in weight control and glycemic management.In PCOS (Polycystic Ovary Syndrome), studies have found impaired incretin secretion and activity, particularly in overweight/obese individuals.Conflicting results exist regarding GLP-1 levels in PCOS patients, with studies reporting reduced, normal, or increased levels.After an oral glucose tolerance test, increased GIP and lower GLP-1 concentrations have been observed in women with PCOS. Reduced GLP-1 levels are also associated with impaired glucose tolerance (IGT) and impaired fasting glucose (IFG), which are early indicators of prediabetes and potential progression to Type 2 Diabetes Mellitus.Incretin-based therapy has been suggested as a potential treatment to reverse prediabetes risk by preserving β-cell function in patients with IFG and IGT. The study aims to compare the efficacy of Dapagliflozin to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
oral Dapagliflozin
oral metformin
October 6 University Hospital
Giza, Egypt
RECRUITINGFertility parameters- Luteinizing hormone
Luteinizing hormone (LH) in IU/L
Time frame: 3-6 months
Fertility parameters-Follicle-stimulating hormone
Follicle-stimulating hormone (FSH) in mIU/mL
Time frame: 3-6 months
Fertility parameters-Free androgen index
Free androgen index \[ Time Frame: 3-6 months\]
Time frame: 3-6 months
Fertility parameters-Total testosterone
Total testosterone in ng/dL
Time frame: 3-6 months
Transvaginal ultrasonography
disappearance of PCOS
Time frame: 3-6 months
Menstrual diaries
Menstruation pattern
Time frame: 3-6 months
Metabolic parameters
Fasting blood glucose (FBG) in mg/dL
Time frame: 3-6 months
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