Migraine and CVD Risk in Women

September 26, 2023 updated by: University of Pennsylvania

Mechanisms of Increased Cardiovascular Disease Risk in Women With Migraine

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19004
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
LPS is measured at baseline every 30 minutes for 4 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
FMD is measured at baseline and 2.5 hours after MMTT.
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).
Sympathetic tone at rest and with painful stimulus are measured at baseline and 3 hours after MMTT.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

June 30, 2020

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

February 16, 2017

First Submitted That Met QC Criteria

March 10, 2017

First Posted (Actual)

March 16, 2017

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 826251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine

Clinical Trials on Mixed meal tolerance testing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe