Effect of Pioglitazone on Clinical, Biochemical and Hormonal Parameters of Insulin Resistant PCOS in Comparison to Metformin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- biochemical parameters of insulin resistant PCOS
研究概览
简要总结
Women with PCOS with HOMA-IR >2 fulfilling inclusion and exclusion criteria are randomly allocated into two groups: group A: pioglitazone 30 mg once daily and group B: Metformin 500 thrice daily for 3 months.Each group contains 30 participants. Outcome variables are measured after 3 months.
详细描述
This study will be conducted in the Department of Reproductive Endocrinology and Infertility, Bangladesh Medical University from the day of IRB approval. Ethical clearance will be obtained from the Institutional Review Board. Selection of the patients will be done according to inclusion and exclusion criteria. Insulin resistant PCOS patients will be included only. The patients will be explained in details regarding the objectives, rationality and potential benefits of the study. The patients will be counseled regarding the drugs and unexpected side-effect and an informed written consent will be taken. Data will be collected through interview, physical examinations and laboratory investigations. All the data will be enrolled in the data sheet for this study. The random sequence generation of permuted block will be done by computer-generated random numbers. Eligible women will be randomized to either pioglitazone group (Group A) or metformin group (Group B).
Allocation concealment will be done using serially numbered closed opaque envelopes.
Each envelope will have a card inside noting the intervention drug. Allocation will not be changed after opening the closed envelopes.
Group A: Participants will receive Tab. Pioglitazone 30mg once daily for 12 weeks.
Group B: Participants will receive Tab. Metformin 500mg thrice daily for 12 weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed case of PCOS patients according to Rotterdam criteria
- •HOMA-IR >2 (Hydrie et al., 2012)
- •Age: 18-35 years
- •BMI: 18.5 -27.5 kg/m²
排除标准
- •Presence of any endocrine disorder (hyperthyroidism, hypothyroidism, cushing syndrome, congenital adrenal hyperplasia, hyperprolactinaemia, diabetes mellitus).
- •Presence of any medical comorbidity (renal, hepatic and cardiovascular disease)
- •Any medication in the last three months which would affect insulin resistance (metformin, oral contraceptive pill)
- •Any contraindications to Pioglitazone (Patients with a known hypersensitivity to pioglitazone or any of its components, Diabetic ketoacidosis or type 1 diabetes) or Metformin (severe chronic diseases e.g. hepatic, renal and cardiac failure or acute complications of diabetes e.g. ketoacidosis and hyperosmolar state).
研究组 & 干预措施
Comparator arm
metformin 500mg thrice daily for 3 months
干预措施: Pioglitazone 30 Mg Oral Tablet (Drug)
Comparator arm
metformin 500mg thrice daily for 3 months
干预措施: metformin 500 mg thrice daily (Drug)
Experimental arm
pioglitazone 30 mg once daily
干预措施: Pioglitazone 30 Mg Oral Tablet (Drug)
Experimental arm
pioglitazone 30 mg once daily
干预措施: metformin 500 mg thrice daily (Drug)
结局指标
主要结局
biochemical parameters of insulin resistant PCOS
时间窗: baseline to 3 months
Biochemical: 1\. HOMA-IR
clinical parameter
时间窗: 3 months
waist hip ratio
hormonal parameter
时间窗: 3 months
free androgen index
次要结局
未报告次要终点
研究者
Mst.Sumyara Khatun
Medical Officer
Bangladesh Medical University