Mechanisms of Increased Cardiovascular Disease Risk in Women With Migraine
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- LPS area under the curve (AUC)
研究概览
简要总结
The primary goal of this study is to test the effects of a high-fat, high-carbohydrate mixed meal on candidate modulators of cardiovascular disease risk (inflammation, vascular reactivity, sympathetic nervous system tone, and response to pain) in young adult women with migraine compared with healthy young women. This is study enrolling both cases (women with migraine) and controls (women without migraine), with equal numbers of normal weight and obese women in each group. Participants will undergo a telephone screening and a single day in-person study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Female 18-35 years of age, inclusive
- •BMI 18.5-24.9 kg/m2, inclusive
- •BMI ≥30 kg/m2
- •Inclusion Criteria (cases only):
- •Diagnosis of migraine per ICHD-3-beta (1-10 migraine days per month)
排除标准
- •Smoking (current or former)
- •Chronic use of medications, including oral contraceptives
- •Major medical or psychiatry illness (e.g. diabetes, fibromyalgia, major depression/anxiety)
- •Pregnant or nursing
- •Allergies or sensitivity to any of the ingredients of the meal
- •Inability to fast for 10 hours and/or abstain from caffeine intake for 24 hours
- •Treatment with antibiotics or steroids within the previous 3 months
- •Treatment with NSAIDs within the previous 1 week
- •Exclusion Criteria (controls only):
- •Migraine headaches, or headaches other than tension-type headaches with a frequency of 1 or fewer days per month
研究组 & 干预措施
No migraine, normal weight
- Mixed meal tolerance testing
- Skin conductance & cold pressor test
- Flow-mediated dilation testing
干预措施: Mixed meal tolerance testing (Other)
No migraine, normal weight
- Mixed meal tolerance testing
- Skin conductance & cold pressor test
- Flow-mediated dilation testing
干预措施: Skin conductance & cold pressor test (Other)
No migraine, normal weight
- Mixed meal tolerance testing
- Skin conductance & cold pressor test
- Flow-mediated dilation testing
干预措施: Flow-mediated dilation testing (Other)
No migraine, obese
- Mixed meal tolerance testing
- Skin conductance & cold pressor test
- Flow-mediated dilation testing
干预措施: Mixed meal tolerance testing (Other)
No migraine, obese
- Mixed meal tolerance testing
- Skin conductance & cold pressor test
- Flow-mediated dilation testing
干预措施: Skin conductance & cold pressor test (Other)
No migraine, obese
- Mixed meal tolerance testing
- Skin conductance & cold pressor test
- Flow-mediated dilation testing
干预措施: Flow-mediated dilation testing (Other)
Migraine, normal weight
- Mixed meal tolerance testing
- Skin conductance & cold pressor test
- Flow-mediated dilation testing
干预措施: Mixed meal tolerance testing (Other)
Migraine, normal weight
- Mixed meal tolerance testing
- Skin conductance & cold pressor test
- Flow-mediated dilation testing
干预措施: Skin conductance & cold pressor test (Other)
Migraine, normal weight
- Mixed meal tolerance testing
- Skin conductance & cold pressor test
- Flow-mediated dilation testing
干预措施: Flow-mediated dilation testing (Other)
Migraine, obese
- Mixed meal tolerance testing
- Skin conductance & cold pressor test
- Flow-mediated dilation testing
干预措施: Skin conductance & cold pressor test (Other)
Migraine, obese
- Mixed meal tolerance testing
- Skin conductance & cold pressor test
- Flow-mediated dilation testing
干预措施: Mixed meal tolerance testing (Other)
Migraine, obese
- Mixed meal tolerance testing
- Skin conductance & cold pressor test
- Flow-mediated dilation testing
干预措施: Flow-mediated dilation testing (Other)
结局指标
主要结局
LPS area under the curve (AUC)
时间窗: LPS is measured at baseline every 30 minutes for 4 hours.
The primary study endpoint is lipopolysaccharide (LPS) area under the curve (AUC) during MMTT.
次要结局
- Flow-mediated dilation (FMD)(FMD is measured at baseline and 2.5 hours after MMTT.)
- Sympathetic tone at rest and with painful stimulus(Sympathetic tone at rest and with painful stimulus are measured at baseline and 3 hours after MMTT.)