Comparing the Effects of Empagliflozin and Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome With or Without Comorbidity or Multimorbidity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Irregular menstruations assessment
研究概览
简要总结
this is open labelled randomize control trial among women with PCOS. PCOS, an endocrine condition, affects 5%-15% of premenopausal women. PCOS is characterized by atypical menstruation, ovulation difficulties, hyperandrogenemia, insulin resistance, and other metabolic abnormalities. Metformin is now an option for PCOS. The clinical reactions to metformin are limited and varied. Novel SGLT2 inhibitors treat type 2 diabetes with weight loss, insulin resistance reduction, and cardiovascular benefits. There is little evidence on SGLT2 inhibitor effectiveness in PCOS patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women participants belong to the reproductive age group, i.e., 18 to 45 years will be included in the study.
- •All those women of BMI of greater than 25 kg/m2 will be included in this study
- •Women with a diagnosis of PCOS by using two (hyperandrogenism and oligo-anovulation) out of three (oligo-anovulation, hyperandrogenism and polycystic ovaries) Rotterdam criteria 2 which confirm hyperandrogenism (acne, seborrhea, hair loss on the scalp, increased body or facial hair) on clinical judgement will be included in the study
- •Those who documented and self-reported oligomenorrhea (cycle length greater than 35 days and nine or fewer periods per year) will be included. or
- •Those who report amenorrhea (absence of menses for a period of 3 months) will be inclusion criteria of the study.
- •6- PCO Women with or without comorbidity or Multimorbidity specifically, Hypothyroidism, Diabetes, Hypertension.
排除标准
- •Women of non-classical 21-hydroxylase deficiency, hyperprolactinemia, Cushing's disease, or androgen- secreting tumors will be streaked from participating.
- •In addition to this, Pregnancy or intent to become pregnant, breastfeeding, documented use of oral hormonal contraceptives and hormone- releasing implants, clomiphene citrate or oestrogen modulators, gonadotropin-releasing hormone (GnRH) modulators and Minoxidil will be excluded.
- •History or presence of malignant neoplasms within the last one years, pancreatitis (acute or chronic) will also be excluded from the study
- •Women with recurrent complaint of urinary tract infection (UTI)will be excluded from the study.
研究组 & 干预措施
Empagliflozin 10mg
Each participant will receive empagliflozin 10mg daily for 6 months
干预措施: Empagliflozin 10 MG (Drug)
Metformin 500mg
Each participant will receive metformin 1000mg daily for 6 months
干预措施: MetFORMIN 500 Mg Oral Tablet (Drug)
结局指标
主要结局
Irregular menstruations assessment
时间窗: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily
Assessment of Irregular menstruation measured by menstruations lasts 2 to 7 days after three months of treatment with either empagliflozin 10mg or metformin 1000mg daily.
次要结局
- Body weight(Six months treatment with either empagliflozin 10mg or metformin 1000mg daily)
- Systolic Blood Pressure (SBP)(Six months treatment with either empagliflozin 10mg or metformin 1000mg daily)
- Lipid profile measured through biochemical test(Six months treatment with either empagliflozin 10mg or metformin 1000mg daily)
- Hb1c test(Six months treatment with either empagliflozin 10mg or metformin 1000mg daily)
- fasting blood-glucose measured through biochemical test(Six months treatment with either empagliflozin 10mg or metformin 1000mg daily)
- Diastolic Blood Pressure (DBP)(Six months treatment with either empagliflozin 10mg or metformin 1000mg daily)
研究者
Hina Sharif
Assistant Manager
SINA Health Education and Welfare Trust