Migraine and CVD Risk in Women

Last updated: August 29, 2024
Sponsor: University of Pennsylvania
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Pain (Pediatric)

Migraine (Adult)

Oral Facial Pain

Treatment

Skin conductance & cold pressor test

Mixed meal tolerance testing

Flow-mediated dilation testing

Clinical Study ID

NCT03081390
826251
  • Ages 18-35
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria (controls only):

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

Study Design

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: Skin conductance & cold pressor test
Phase:
Study Start date:
April 01, 2017
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19004
    United States

    Site Not Available

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