Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2017-04-01
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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No migraine, normal weight
* Mixed meal tolerance testing
* Skin conductance \& cold pressor test
* Flow-mediated dilation testing
Mixed 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.
Skin 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.
Flow-mediated dilation testing
At baseline and post-meal, we will assess flow-mediated dilation at the brachial artery using well-validated ultrasound techniques.
No migraine, obese
* Mixed meal tolerance testing
* Skin conductance \& cold pressor test
* Flow-mediated dilation testing
Mixed 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.
Skin 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.
Flow-mediated dilation testing
At baseline and post-meal, we will assess flow-mediated dilation at the brachial artery using well-validated ultrasound techniques.
Migraine, normal weight
* Mixed meal tolerance testing
* Skin conductance \& cold pressor test
* Flow-mediated dilation testing
Mixed 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.
Skin 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.
Flow-mediated dilation testing
At baseline and post-meal, we will assess flow-mediated dilation at the brachial artery using well-validated ultrasound techniques.
Migraine, obese
* Mixed meal tolerance testing
* Skin conductance \& cold pressor test
* Flow-mediated dilation testing
Mixed 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.
Skin 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.
Flow-mediated dilation testing
At baseline and post-meal, we will assess flow-mediated dilation at the brachial artery using well-validated ultrasound techniques.
Interventions
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Mixed 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.
Skin 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.
Flow-mediated dilation testing
At baseline and post-meal, we will assess flow-mediated dilation at the brachial artery using well-validated ultrasound techniques.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
35 Years
FEMALE
Yes
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Shana E McCormack, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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826251
Identifier Type: -
Identifier Source: org_study_id
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