metformin
DrugMetformin is a widely used insulin-sensitizing agent and one of the most established pharmacological treatments for the metabolic abnormalities associated with polycystic ovary syndrome (PCOS).
NCT Number: NCT07810998
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).
Trial opening soon.
Get Notified18 year–40 year
Female
Interventional
Phase 2 / Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.
Age: >18 <40 years. Infertile women (primary or secondary infertility)
Exclusion criteria
Patients with history of diabetes mellitus (Type 1 or 2). Patients with liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event within last three months and uncontrolled endocrine or metabolic disease.
Use of hormonal medications, lipid-lowering (statins, etc.), anti-obesity drugs or weight loss medications (prescription or OTC) and medications known to exacerbate glucose tolerance (such as isotretinoin, hormonal contraceptives, glucocorticoids, anabolic steroids) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors stopped for at least 4 weeks.
Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
Presence of hypersensitivity to dapagliflozin or other Sodium/glucose cotransporter 2 (SGLT2) inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions).
Use of Metformin, Thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors Eating disorders (anorexia, bulimia) or gastrointestinal disorders. Having a history of bariatric surgery.
Metformin is a widely used insulin-sensitizing agent and one of the most established pharmacological treatments for the metabolic abnormalities associated with polycystic ovary syndrome (PCOS).
Dapagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that promotes urinary glucose and sodium excretion by reducing renal glucose reabsorption. Beyond its established role in type 2 diabetes, dapagliflozin has attracted interest as a potential therapeutic option for polycystic ovary syndrome
Time frame: 3-months
Measurement of Luteinizing hormone
Time frame: 3-months
Measurment of Luteinizing hormone
Time frame: 3-months
Measurement of Total testosterone
Trial opening soon.
Get NotifiedTanta University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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