Acupuncture or Metformin for Insulin Resistance in Women With Polycystic Ovary Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 303
- 试验地点
- 2
- 主要终点
- Changes from baseline to after 4 months of treatment in HbA1c
研究概览
简要总结
The hypothesis is that acupuncture is equally effective as metformin (both treatments combined with lifestyle management) in improving whole body glucose homeostasis in insulin resistant women with polycystic ovary syndrome (PCOS), and that both are superior to lifestyle management alone. The investigators hypothesize that acupuncture and metformin induce ovulation and improve hyperandrogenism, as well as health related quality of life (HRQoL) and symptoms of anxiety and depression. Although equally effective (acupuncture and metformin), the investigators hypothesize that acupuncture is associated with less negative side-effects. The investigators also hypothesize that these treatments have the potential to restore epigenetic and molecular alterations in target tissues (endometrial-, adipose-, and skeletal muscle tissue) and thus have the potential to prevent the development of type 2 diabetes (T2D).
详细描述
Specific Aims The purpose of the study is to perform a randomized controlled trial of women with PCOS, comparing the effectiveness of lifestyle management alone, and in combination with acupuncture or metformin treatment on whole body glucose homeostasis, with the ultimate goal to prevent the development of type 2 diabetes.
Primary aim
- To determine the clinical effectiveness of 4 months of 1) electroacupuncture + lifestyle management and 2) metformin + lifestyle management, compared to 3) lifestyle management only, for improvement of insulin sensitivity as measured by HOMA-IR, by the insulin response to glucose assessed by calculating the area under the curve (AUCinsulin) during the oral glucose tolerance test (OGTT), and by glucose regulation (assessed by analyzing Hba1c levels).
Secondary aims
- To evaluate changes in secondary metabolic measures, including fasting insulin, c-peptide, glucose, and adipokines, calculation of HOMA-B (i.e. the Islet β-cell function) and the c-peptide index, assessment of the adipokines and lipid profile, body size and proportions and body fat distribution.
- To determine changes in genome-wide gene expression and DNA methylation profiles related to insulin sensitivity in fat, muscle and endometrial tissue biopsies, and biomarkers in whole blood.
- To evaluate endocrine measures including menstrual pattern and ovulation frequency, circulating hormones (sex steroids, AMH, gonadotropins), and excretion of metabolites of sex steroids in urine.
- To determine changes in women's HRQoL, symptoms of anxiety and depression, dieting and eating patterns, and negative side-effects.
- To evaluate the cost-effectiveness of the different treatments.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Acupuncture + lifestyle management
Three treatment per week (4 weeks) and thereafter 2 times per week during 12 weeks.
干预措施: Acupuncture (Device)
Lifestyle management
All women will receive lifestyle management instructions at the baseline visit, before randomization.
干预措施: Lifestyle management (Other)
Acupuncture + lifestyle management
Three treatment per week (4 weeks) and thereafter 2 times per week during 12 weeks.
干预措施: Lifestyle management (Other)
Metformin + lifestyle management
Oral metformin 500 mg three times daily, in total 1500 mg per day.
干预措施: Lifestyle management (Other)
Metformin + lifestyle management
Oral metformin 500 mg three times daily, in total 1500 mg per day.
干预措施: Metformin (Drug)
结局指标
主要结局
Changes from baseline to after 4 months of treatment in HbA1c
时间窗: 4 months
Changes from baseline to after 4 months of treatment in HbA1c between 1) acupuncture + lifestyle management and 2) metformin + lifestyle management compared to 3) lifestyle management only.
Changes from baseline to after 4 months in HOMA-IR [fasting insulin (μU/mL) × fasting glucose (mmol/L)] / 22.5)
时间窗: 4 months
Changes from baseline to after 4 months of treatment in HOMA-IR \[fasting insulin (μU/mL) × fasting glucose (mmol/L)\] / 22.5) between 1) acupuncture + lifestyle management and 2) metformin + lifestyle management compared to 3) lifestyle management only.
Changes from baseline to after 4 months of treatment in insulin response to glucose during the oral glucose tolerance test (OGTT)
时间窗: 4 months
Changes from baseline to after 4 months of treatment in insulin response to glucose during the OGTT (AUC using the trapezoidal rule) between 1) acupuncture + lifestyle management and 2) metformin + lifestyle management compared to 3) lifestyle management only.
次要结局
- Changes from baseline to after 4 months and again 4 months after last treatment in secondary metabolic measures(8 months)
- Changes from baseline to after 4 months and again 4 months after last treatment in circulating reproductive hormones.(8 months)
- Changes from baseline to after 4 months and again 4 months after last treatment in women's HRQoL.(8 months)
- Changes from baseline to after 4 months and again 4 months after last treatment in women's symptoms of anxiety and depression.(8 months)
- Cost-effectiveness of the different treatments throughout the study.(8 months)
- Changes from baseline to after 4 months and again 4 months after last treatment in menstrual pattern.(8 months)
- Changes from baseline to after 4 months and again 4 months after last treatment gene expression and DNA methylation profiles related to insulin sensitivity in fat, muscle and endometrial tissue biopsies, and biomarkers in whole blood.(8 months)
- Changes from baseline to after 4 months and again 4 months after last treatment in women's dieting and eating patterns.(8 months)
研究者
Elisabet Stener-Victorin
PhD, Associate Professor
Karolinska Institutet