Poly Cystic Ovary Syndrome
Conditions
Brief summary
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).
Interventions
DRUGMetformin
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
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blinded
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fertility parameters- Luteinizing hormone | 3-months | Measurement of Luteinizing hormone |
| Fertility parameters- Follicle stimulating hormone | 3-months | Measurment of Luteinizing hormone |
| Fertility parameters-Total testosterone | 3-months | Measurement of Total testosterone |
Contacts
CONTACTMostafa M Bahaa, PhD
Outcome results
None listed