Effects of Routine Metformin Therapy on Insulin Resistance, Iron Metabolism, Erythropoietin, Lipid Profile, and Hematological Parameters in Jordanian Women With Polycystic Ovary Syndrome: A Prospective Longitudinal Interventional Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in insulin resistance (HOMA-IR)
研究概览
简要总结
This prospective longitudinal interventional study aims to evaluate the effects of routine metformin therapy on metabolic, iron-related, erythropoietin, lipid, and hematological parameters in adult women with polycystic ovary syndrome (PCOS). Participants diagnosed with PCOS according to established diagnostic criteria receive routine metformin therapy for six months as part of standard clinical care. Clinical and laboratory assessments are performed at baseline, three months, and six months to evaluate changes in insulin resistance, fasting blood glucose, fasting serum insulin, serum ferritin, serum iron, erythropoietin (EPO), lipid profile, and hematological indices. The study also examines the relationships between metabolic, iron-related, and hematological biomarkers during metformin treatment.
详细描述
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders affecting women of reproductive age and is frequently associated with insulin resistance, dyslipidemia, obesity, and an increased risk of metabolic complications. Although metformin is widely prescribed to improve insulin sensitivity in women with PCOS, its effects on iron metabolism, erythropoietin concentrations, and hematological parameters remain incompletely understood.
This prospective longitudinal interventional study was conducted among adult women with PCOS attending obstetrics and gynecology clinics of the Jordanian Ministry of Health. Eligible participants received routine metformin therapy (500 mg twice daily) for six months as part of standard clinical practice. No additional behavioral, lifestyle, dietary, or educational interventions were provided as part of the study protocol.
Clinical and laboratory assessments were performed at baseline, after three months, and after six months of treatment. Outcome measures included body mass index (BMI), fasting blood glucose (FBG), fasting serum insulin, homeostatic model assessment of insulin resistance (HOMA-IR), lipid profile (total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol), serum ferritin, serum iron, erythropoietin (EPO), hemoglobin concentration, complete blood count, and red blood cell indices.
The primary objective was to determine the effects of routine metformin therapy on insulin resistance, iron metabolism, erythropoietin concentrations, and hematological parameters in women with PCOS. Secondary objectives included evaluating changes in lipid profile and investigating the associations among metabolic, iron-related, and hematological biomarkers during the six-month follow-up period.
The findings of this study are expected to improve understanding of the metabolic and hematological effects of routine metformin therapy in women with PCOS and to clarify the relationship between insulin resistance, iron homeostasis, erythropoietin, and metabolic outcomes in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-45 years.
- •Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam diagnostic criteria.
- •Eligible for routine metformin therapy as determined by the treating gynecologist.
- •Willing and able to provide written informed consent.
- •Willing to attend scheduled follow-up visits and complete all study assessments over the six-month study period.
排除标准
- •Pregnancy or breastfeeding.
- •Diagnosis of type 1 diabetes mellitus or established type 2 diabetes requiring insulin therapy.
- •History of chronic kidney disease, chronic liver disease, hematological disorders, malignancy, or other severe systemic diseases.
- •Current use of medications known to affect glucose metabolism, iron metabolism, erythropoietin levels, or hematological parameters within the previous three months, other than routine metformin prescribed as part of the study.
- •Known hypersensitivity or contraindication to metformin. Inability or unwillingness to complete the scheduled follow-up assessments.
- •Participation in another interventional clinical trial during the study period.
研究组 & 干预措施
Routine Metformin Therapy
Adult women diagnosed with polycystic ovary syndrome (PCOS) received routine metformin therapy (500 mg orally twice daily) for six months as part of standard clinical care. Clinical and laboratory assessments were performed at baseline, three months, and six months to evaluate changes in insulin resistance, iron metabolism, erythropoietin concentrations, lipid profile, and hematological parameters.
干预措施: Metformin (Drug)
结局指标
主要结局
Change in insulin resistance (HOMA-IR)
时间窗: Baseline and 6 months
To evaluate the change in insulin resistance using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) following six months of routine metformin therapy in women with polycystic ovary syndrome.
Change in serum ferritin concentration
时间窗: Baseline and 6 months
To evaluate the change in serum ferritin concentration after six months of routine metformin therapy.
次要结局
- Change in fasting blood glucose(Baseline and 6 months)
- Change in fasting serum insulin(Baseline and 6 months)
- Change in serum iron concentration(Baseline and 6 months)
- Change in hematological parameters(Baseline and 6 months)
- Change in body mass index (BMI)(Baseline and 6 months)
研究者
JAWAD AHMAD ABU-SHENNAR
Asst.Prof.Dr
Jerash Private University