Migraine and CVD Risk in Women

Not Applicable

Active, not recruiting

• Conditions: Migraine
• Interventions: Other: Mixed meal tolerance testing; Other: Skin conductance & cold pressor test; Other: Flow-mediated dilation testing

• Registration Number: NCT03081390
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-16
• Study Start: 2017-04-01
• Primary Completion: 2020-06-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Migraine, normal weight	Mixed meal tolerance testing	* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing
Migraine, normal weight	Flow-mediated dilation testing	* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing
Migraine, obese	Mixed meal tolerance testing	* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing
No migraine, normal weight	Mixed meal tolerance testing	* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing
No migraine, normal weight	Skin conductance & cold pressor test	* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing
No migraine, normal weight	Flow-mediated dilation testing	* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing
No migraine, obese	Flow-mediated dilation testing	* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing
No migraine, obese	Mixed meal tolerance testing	* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing
Migraine, obese	Flow-mediated dilation testing	* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing
No migraine, obese	Skin conductance & cold pressor test	* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing
Migraine, normal weight	Skin conductance & cold pressor test	* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing
Migraine, obese	Skin conductance & cold pressor test	* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing

Primary Outcome Measures

Name	Time	Method
LPS area under the curve (AUC)	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

Name	Time	Method
Flow-mediated dilation (FMD)	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).
Sympathetic tone at rest and with painful stimulus	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).

Trial Locations

Locations (2)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States