Estrogen-Mediated Impairments of Vascular Health in Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 4
- 主要终点
- FMD/Shear
研究概览
简要总结
Diabetes has recently been referred to as "the epidemic of the 21st century". The reason why women with type 1 diabetes have a 2-3 fold greater risk of cardiovascular disease (CVD) compared to men with type 1 diabetes is unknown.The purpose of this study is to investigate whether or not estrogen contributes to vascular dysfunction in premenopausal women with diabetes.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both men and premenopausal
- •Normal menstrual cycle interval of 25-35 days for at least 3 previous cycles
- •All races
- •Clinical diagnosis of insulin-dependent type 1 diabetes (patients only)
排除标准
- •Clinical diagnosis of hepatic, cardiovascular, or renal disease
- •Uncontrolled Diabetes (HbA1c>9%)
- •Diabetic complications (i.e. macrovascular, microvascular, or autonomic)
- •Proteinuria
- •Uncontrolled Hypertension (>140/90 mmHg on therapy)
- •Hormonal use of birth control (past 3 months)
- •Pregnancy
- •Oligomenorrhea
- •Direct vasoactive medications (i.e. nitrates)
- •Anti-estrogens (i.e. SERMs)
- •Plycystic ovarian syndrome (defined by NIH guidelines-hyperandrogenic anovulation)
- •Undetectable Anti-Mullerian Hormone (AMH) following screening
研究组 & 干预措施
Women with type 1 diabetes
Women with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (Antioxidant cocktail, Resveratrol, or placebo)
干预措施: Placebo (Other)
Women with type 1 diabetes
Women with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (Antioxidant cocktail, Resveratrol, or placebo)
干预措施: Antioxidant Cocktail (Dietary Supplement)
Healthy control women
Healthy women who participate will receive no intervention and serve as controls.
Men with type 1 diabetes
Men with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (AOX cocktail, Resveratrol, or placebo)
干预措施: Placebo (Other)
Men with type 1 diabetes
Men with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (AOX cocktail, Resveratrol, or placebo)
干预措施: Antioxidant Cocktail (Dietary Supplement)
结局指标
主要结局
FMD/Shear
时间窗: ~ 2 weeks. Acquired at Menses and Late Follicular phase.
Flow-Mediated Dilation (FMD) controlled for shear
次要结局
未报告次要终点
研究者
Ryan Harris
Associate Professor
Augusta University