A Treatment Legacy Effect of Metformin on Metabolic and Endocrine Parameters in Obese Women With Polycystic Ovary Syndrome (PCOS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The main outcome was change in body weight.
研究概览
简要总结
Metformin has multiple health promoting effects and it may serve as a preventive measure for individuals who are at high risk for metabolic complications.
According to the latest international guidelines it should be considered as an adjunct therapy to lifestyle intervention in all overweight/obese women with PCOS, independently of their glucose homeostasis and menstrual regularity. However, there is no clear answer for how long metformin should be prescribed in this subset of women with PCOS and for how long the beneficial impact would sustain after treatment cessation.
The investigators compared the consequences of metformin withdrawal after long-term therapy as opposed to the consequences of metformin suspension after short term therapy in overweight/obese women with PCOS that had previously responded to metformin by means of moderate weight loss, improved menstrual frequency and sustained normal glucose homeostasis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PCOS defined by the National Institute of Child Health and Human Development (NICHD) criteria
- •obesity with body mass index ≥ 30 kg/m2
- •normal glucose homeostasis at metformin treatment
排除标准
- •known type 1 or type 2 diabetes mellitus
- •heart failure
- •renal insufficiency with serum creatinine more than 125 umol/L
- •arterial hypertension
- •pregnancy
- •BMI below 25 kg/m2
研究组 & 干预措施
Group A
Obese women who have been treated with metformin for one year prior to the study.
干预措施: Metformin (Drug)
Group B
Obese women who have been treated with metformin for at least three years prior to the study.
干预措施: Metformin (Drug)
结局指标
主要结局
The main outcome was change in body weight.
时间窗: Patient's body weight was measured at the base point and at the endpoint of 6 months of clinical trial.
The main outcome was change in insulin resistance measured with homeostasis model assessment (HOMA IR).
时间窗: HOMA IR was calculated at the base point and at the endpoint of 6 months of clinical trial.
HOMA IR was calculated as the product of the fasting glucose and insulin concentration divided by 22.5.
The main outcome was change in expression of glucose transporter type 4 (GLUT-4) in adipose tissue.
时间窗: We did adipose tissue needle biopsy at the base point and at the endpoint of 6 months of clinical trial. All samples were frozen and then analysed together after end point of the study.
We obtained adipose tissue using needle biopsy, from which we isolated ribonucleic acid and after reverse transcription, real-time quantitative polymerase chain reaction determined messenger ribonucleic acid expression for GLUT-4.
次要结局
未报告次要终点
研究者
Andrej Janez
Clinical Professor
University Medical Centre Ljubljana