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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No migraine, normal weight | Experimental |
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| No migraine, obese | Experimental |
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| Migraine, normal weight | Experimental |
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| Migraine, obese | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mixed meal tolerance testing | Other | An intravenous catheter is placed for serial blood draws for inflammatory markers and ancillary studies. The participant consumes a test meal, and measurements are made for 4 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| LPS area under the curve (AUC) | The primary study endpoint is lipopolysaccharide (LPS) area under the curve (AUC) during MMTT. | LPS is measured at baseline every 30 minutes for 4 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Flow-mediated dilation (FMD) | Vascular reactivity via brachial artery ultrasound, expressed as flow-mediated dilation (% of baseline diameter, normalized). | FMD is measured at baseline and 2.5 hours after MMTT. |
| Sympathetic tone at rest and with painful stimulus |
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Inclusion Criteria (all):
Inclusion Criteria (cases only):
Exclusion Criteria (all):
Exclusion Criteria (controls only):
Self-reported female.
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| Name | Affiliation | Role |
|---|---|---|
| Shana E McCormack, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19004 | United States | ||
| Children's Hospital of Philadelphia |
After the primary publication is complete, interested investigators can request these data without identifiers. The study team will evaluate the request for scientific rigor and ensure consistency with our protocol, and then provide data without identifiers via secure file-share. This will include the subset of participants who indicated their data could be used for ancillary and/or future studies.
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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There are four total groups of participants, stratified according to migraine status (yes/no) and obesity status (yes/no). All undergo the same experimental phenotyping procedures.
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| Skin conductance & cold pressor test | Other | Skin conductance will be monitored continuously with 2 electrodes placed on the plantar surface of the foot. To induce pain, we will use the cold pressor test. Participants submerge one hand in a bath with iced water (2-4ÂșC) for 2 minutes. Blood pressure and heart rate are monitored every minute starting 5 minutes before the cold pressor test and for 10 minutes after the participant withdraws the hand from the bath. This testing will be performed at baseline and post-meal. |
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| Flow-mediated dilation testing | Other | At baseline and post-meal, we will assess flow-mediated dilation at the brachial artery using well-validated ultrasound techniques. |
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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). |
| Sympathetic tone at rest and with painful stimulus are measured at baseline and 3 hours after MMTT. |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| D009422 | Nervous System Diseases |