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Migraine and CVD Risk in Women

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ClinicalTrials.gov Identifier: NCT03081390
Recruitment Status : Recruiting
First Posted : March 16, 2017
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Migraine Other: Mixed meal tolerance testing Other: Skin conductance & cold pressor test Other: Flow-mediated dilation testing

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Mechanisms of Increased Cardiovascular Disease Risk in Women With Migraine
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: No migraine, normal weight
  • Mixed meal tolerance testing
  • Skin conductance & cold pressor test
  • Flow-mediated dilation testing
Other: 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.
Other: 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.
Other: Flow-mediated dilation testing
At baseline and post-meal, we will assess flow-mediated dilation at the brachial artery using well-validated ultrasound techniques.
Experimental: No migraine, obese
  • Mixed meal tolerance testing
  • Skin conductance & cold pressor test
  • Flow-mediated dilation testing
Other: 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.
Other: 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.
Other: Flow-mediated dilation testing
At baseline and post-meal, we will assess flow-mediated dilation at the brachial artery using well-validated ultrasound techniques.
Experimental: Migraine, normal weight
  • Mixed meal tolerance testing
  • Skin conductance & cold pressor test
  • Flow-mediated dilation testing
Other: 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.
Other: 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.
Other: Flow-mediated dilation testing
At baseline and post-meal, we will assess flow-mediated dilation at the brachial artery using well-validated ultrasound techniques.
Experimental: Migraine, obese
  • Mixed meal tolerance testing
  • Skin conductance & cold pressor test
  • Flow-mediated dilation testing
Other: 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.
Other: 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.
Other: Flow-mediated dilation testing
At baseline and post-meal, we will assess flow-mediated dilation at the brachial artery using well-validated ultrasound techniques.


Outcome Measures

Primary Outcome Measures :
  1. LPS area under the curve (AUC) [ Time Frame: 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 :
  1. Flow-mediated dilation (FMD) [ Time Frame: 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).

  2. Sympathetic tone at rest and with painful stimulus [ Time Frame: 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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-reported female.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (all):

  • Female 18-29 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

Exclusion Criteria (controls only):

  • Migraine headaches, or headaches other than tension-type headaches with a frequency of 1 or fewer days per month
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081390


Contacts
Contact: Maghenn Cosico (267) 425-2169 cosicom@email.chop.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19004
Contact: Shana E McCormack, MD       mccormacks1@email.chop.edu   
Principal Investigator: Shana E McCormack, MD         
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Shana E McCormack, MD       mccormacks1@email.chop.edu   
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Ana Recober, MD Children's Hospital of Philadelphia
Principal Investigator: Shana E McCormack, MD Children's Hospital of Philadelphia
More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03081390     History of Changes
Other Study ID Numbers: 826251
First Posted: March 16, 2017    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases