Migraine
Conditions
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.
Interventions
OTHERMixed meal tolerance testing
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.
OTHERSkin conductance & cold pressor test
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 (2-4ºC) 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.
OTHERFlow-mediated dilation testing
At baseline and post-meal, we will assess flow-mediated dilation at the brachial artery using well-validated ultrasound techniques.
Sponsors
University of Pennsylvania
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Outcome results
None listed