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Migraine and CVD Risk in Women

Primary Purpose

Migraine

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mixed meal tolerance testing

Skin conductance & cold pressor test

Flow-mediated dilation testing

About this trial

This is an interventional other trial for Migraine

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

University of Pennsylvania
Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

No migraine, normal weight

No migraine, obese

Migraine, normal weight

Migraine, obese

Arm Description

Mixed meal tolerance testing Skin conductance & cold pressor test Flow-mediated dilation testing

Outcomes

Primary Outcome Measures

LPS area under the curve (AUC)

The primary study endpoint is lipopolysaccharide (LPS) area under the curve (AUC) during MMTT.

Secondary Outcome Measures

Flow-mediated dilation (FMD)

Vascular reactivity via brachial artery ultrasound, expressed as flow-mediated dilation (% of baseline diameter, normalized).

Sympathetic tone at rest and with painful stimulus

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).

Full Information

NCT ID

NCT03081390

First Posted

February 16, 2017

Last Updated

September 26, 2023

Sponsor

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT03081390

Brief Title

Migraine and CVD Risk in Women

Official Title

Mechanisms of Increased Cardiovascular Disease Risk in Women With Migraine

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 1, 2017 (Actual)

Primary Completion Date

June 30, 2020 (Actual)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

No migraine, normal weight

Arm Type

Experimental

Arm Description

Mixed meal tolerance testing Skin conductance & cold pressor test Flow-mediated dilation testing

Arm Title

No migraine, obese

Arm Type

Experimental

Arm Description

Mixed meal tolerance testing Skin conductance & cold pressor test Flow-mediated dilation testing

Arm Title

Migraine, normal weight

Arm Type

Experimental

Arm Description

Mixed meal tolerance testing Skin conductance & cold pressor test Flow-mediated dilation testing

Arm Title

Migraine, obese

Arm Type

Experimental

Arm Description

Mixed meal tolerance testing Skin conductance & cold pressor test Flow-mediated dilation testing

Intervention Type

Other

Intervention Name(s)

Mixed meal tolerance testing

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Skin conductance & cold pressor test

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Flow-mediated dilation testing

Intervention Description

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

Primary Outcome Measure Information:

Title

LPS area under the curve (AUC)

Description

The primary study endpoint is lipopolysaccharide (LPS) area under the curve (AUC) during MMTT.

Time Frame

LPS is measured at baseline every 30 minutes for 4 hours.

Secondary Outcome Measure Information:

Title

Flow-mediated dilation (FMD)

Description

Vascular reactivity via brachial artery ultrasound, expressed as flow-mediated dilation (% of baseline diameter, normalized).

Time Frame

FMD is measured at baseline and 2.5 hours after MMTT.

Title

Sympathetic tone at rest and with painful stimulus

Description

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).

Time Frame

Sympathetic tone at rest and with painful stimulus are measured at baseline and 3 hours after MMTT.

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Self-reported female.

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ana Recober, MD

Organizational Affiliation

Children's Hospital of Philadelphia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Shana E McCormack, MD

Organizational Affiliation

Children's Hospital of Philadelphia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19004

Country

United States

Facility Name

Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Migraine and CVD Risk in Women

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