Migraine and CVD Risk in Women
- Conditions
- Migraine
- Registration Number
- NCT03081390
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method LPS area under the curve (AUC) 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.
- Secondary Outcome Measures
Name Time Method Flow-mediated dilation (FMD) FMD is measured at baseline and 2.5 hours after MMTT. Vascular reactivity via brachial artery ultrasound, expressed as flow-mediated dilation (% of baseline diameter, normalized).
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. Sympathetic tone via skin conductance is expressed as mean skin conductance level (SCL) in microsiemens, and assessed at rest and following a pain stimulus (cold pressor test).
Trial Locations
- Locations (2)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Pennsylvania🇺🇸Philadelphia, Pennsylvania, United States