Effects of Metformin and Combination of Metformin and Pioglitazone on Plasma Interleukin-6 and Interleukin-8 Levels in Polycystic Ovarian Syndrome
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Cytokines and Chemokines Measurements
研究概览
简要总结
Objective:
- To investigate the changes in the levels of interleukin-6 and interleukin-8 after 3 months treatment with metformin alone and combination of metformin and pioglitazone in patients with polycystic ovarian syndrome (PCOS).
- To evaluate insulin resistance in all the groups at baseline and after 3 months of treatment.
Design: Two-Arm Randomized Clinical trial.
Setting: Out-Patient Department (OPD) of Mardan Medical Complex, Khyber Medical University.
Patient(s): One hundred and two patients with PCOS.
Intervention(s): 51 women will receive metformin according to the body weight with maximum dose of 1000 mg (BD) daily. Remaining 51 will receive metformin and pioglitazone combination according to the body weight with maximum dose of 1000 mg and 30 mg (BD) daily.
Main outcomes measure(s): Serum concentrations of fasting blood glucose, insulin, homeostatic model assessment for insulin resistance (HOMA-IR), follicle stimulating hormone (FSH), luteinizing hormone (LH), interleukin-6 (IL-6) and i-nterleukin-8 (IL-8).
详细描述
Effects of metformin and combination of metformin and pioglitazone on plasma IL-6 and IL-8 levels in polycystic ovarian syndrome
Sponsor:
Office of Research, Innovation and Commercialization (ORIC)
Khyber Medical University (KMU), Peshawar, Pakistan
Hayatabad, Phase 5.
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed patients of PCOS.
- •Must Swallow the tablet(s).
- •Must give informed consent.
排除标准
- •Women with cushing syndrome, hyperprolactinemia.
- •Late onset congenital adrenal hyperplasia, androgen-producing tumors, pregnancy.
- •Insulin dependent diabetes.
- •Thyroid disease.
- •Medications that alters the biochemical or hormonal profile.
研究组 & 干预措施
Metformin
Drug intervention: Metformin 500 mg tablet twice orally for 3 months
干预措施: Metformin (Drug)
Metformin, pioglitazone
Drugs intervention: Combination of Metformin (1000 mg) and pioglitazone (30 mg) tablets will be given orally for 3 months
干预措施: Metformin, Pioglitazone (Drug)
结局指标
主要结局
Cytokines and Chemokines Measurements
时间窗: Baseline and after 3 Months
IL-6 and IL-8 levels by ELISA method using commercially available kits.
次要结局
- Hormonal Profiles(Baseine and after 3 Months)
- Insulin Resistance(Baseline and after 3 months)
研究者
Mohsin Shah
Assistant Professor
Khyber Medical University Peshawar