Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome: A Prospective Comparative Randomized Blinded Trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Fertility parameters- Luteinizing hormone
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.
- •Age: >18 <40 years.
- •Infertile women (primary or secondary infertility)
排除标准
- •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.
研究组 & 干预措施
Dapagliflozin
Patients will receive Dapagliflozin 10 mg once daily orally for 12 weeks (Forxiga® AstraZeneca company)
干预措施: Dapagliflozin (Drug)
Metformin
Patients will receive Metformin 1000 mg once daily orally for 12 weeks (control group) (Glucophage® Merck company)
干预措施: Metformin (Drug)
结局指标
主要结局
Fertility parameters- Luteinizing hormone
时间窗: 3-6 months
Luteinizing hormone (LH) in IU/L
Fertility parameters-Free androgen index
时间窗: 3-6 months
Free androgen index \[ Time Frame: 3-6 months\]
Fertility parameters-Total testosterone
时间窗: 3-6 months
Total testosterone in ng/dL
Menstrual diaries
时间窗: 3-6 months
Menstruation pattern
Fertility parameters-Follicle-stimulating hormone
时间窗: 3-6 months
Follicle-stimulating hormone (FSH) in mIU/mL
Transvaginal ultrasonography
时间窗: 3-6 months
disappearance of PCOS
次要结局
- Metabolic parameters(3-6 months)
研究者
Nouran Omar El Said
Lecturer in Pharmacy Practice & Clinical Pharmacy
Future University in Egypt