Migraine and CVD Risk in Women
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Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria (all):
- 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)
Exclusion Criteria (all):
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
30 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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