Migraine and CVD Risk in Women

Migraine Clinical Trial

Official title:

Mechanisms of Increased Cardiovascular Disease Risk in Women With Migraine

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03081390
• Other study ID #: 826251
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LPS area under the curve (AUC)	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	Flow-mediated dilation (FMD)	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.
Secondary	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).	Sympathetic tone at rest and with painful stimulus are measured at baseline and 3 hours after MMTT.