Migraine and CVD Risk in Women
Mechanisms of Increased Cardiovascular Disease Risk in Women With Migraine
1 other identifier
interventional
30
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2017
CompletedFirst Posted
Study publicly available on registry
March 16, 2017
CompletedStudy Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedSeptember 8, 2025
September 1, 2025
3.2 years
February 16, 2017
September 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (2)
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.
Study Arms (4)
No migraine, normal weight
EXPERIMENTAL* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing
No migraine, obese
EXPERIMENTAL* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing
Migraine, normal weight
EXPERIMENTAL* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing
Migraine, obese
EXPERIMENTAL* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing
Interventions
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.
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.
At baseline and post-meal, we will assess flow-mediated dilation at the brachial artery using well-validated ultrasound techniques.
Eligibility Criteria
You may qualify if:
- Female 18-35 years of age, inclusive
- BMI 18.5-24.9 kg/m2, inclusive
- BMI ≥30 kg/m2
- Diagnosis of migraine per ICHD-3-beta (1-10 migraine days per month)
You may not qualify if:
- 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
- Migraine headaches, or headaches other than tension-type headaches with a frequency of 1 or fewer days per month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Pennsylvania
Philadelphia, Pennsylvania, 19004, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shana E McCormack, MD
Children's Hospital of Philadelphia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2017
First Posted
March 16, 2017
Study Start
April 1, 2017
Primary Completion
June 30, 2020
Study Completion (Estimated)
June 30, 2026
Last Updated
September 8, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
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.