Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin in Hyperandrogenic Lean PCOS Women
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- High Serum under-carboxylated osteocalcin
研究概览
简要总结
High ucOC may favor insulin release in lean hyperandrogenic women to compensate for impaired insulin sensitivity. Meformin is an insulin sensitizing agent will be given for these women trying to interfere with the pathophysiology of PCOS in these women as followed up by serum UC-OC levels.
详细描述
Under-carboxylated osteocalcin (ucOC), the precursor substrate of bone biomarker OC is a potent regulator of energy metabolism by promoting insulin production and adiponectin synthesis and decreasing fat stores.UcOC has a potential role in the physiopathology of polycystic ovary syndrome (PCOS), a common disorder defined by the constellation of anovulation, insulinresistance, hyperinsulinemia, obesity and androgen excess.Circulating ucOC concentration is related to key endocrine PCOS characteristics in a weight-dependent manner. Within the bone-pancreas loop, high ucOC may favor insulin release in lean hyperandrogenic women to compensate for impaired insulin sensitivity.We will investigate serum uc-OC responses to insulin sensitizing therapies in lean hyperandrogenic polycystic ovary syndrome (PCOS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Lean women BMI 25 or less
- •Hyperandrogenic clinically and/or biochemically.
- •Androgen Excess-Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria
排除标准
- •BMI more than 20
- •Other causes of hyperandrogenism
- •Other causes of metabolic disorders or diabetes.
研究组 & 干预措施
Placebo
Other group of patients with high serum UC-OC will be given a placebo.
干预措施: drug (Other)
Metformin
Cidophage 850 mg twice daily for three months will be given to the patientwith PCOS.
干预措施: Metformin 850 mg twice daily for 3 months (Drug)
Serum under-carboxylated osteocalcin
Serum uc-oc will be measured before and after 3 months of treatment with cidophage.
干预措施: Serum uc-oc (Procedure)
结局指标
主要结局
High Serum under-carboxylated osteocalcin
时间窗: 3 months
Hyperandrogenic lean women will be diagnosed as PCOS according to Androgen Excess-Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria.Serum uc-oc will be assayed when it is found to be high, metformin therapy for three months will be given to these women. Serum uc-oc will be measured again and effect of therapy will be interpreted.
次要结局
- Metformin therapy(3 months)
研究者
Nesreen Abdel Fattah Abdullah Shehata
Lecturer of Obstetrics and Gynecology
Beni-Suef University