Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03081390

Migraine and CVD Risk in Women

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mixed meal tolerance testing

Other

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

Other

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

Other

At baseline and post-meal, we will assess flow-mediated dilation at the brachial artery using well-validated ultrasound techniques.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Mechanisms of Increased Cardiovascular Disease Risk in Women With Migraine

Important dates

Study start
2017
Primary completion
2020
Study completion
2026
First posted
Mar 16, 2017
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.