Migraine and CVD Risk in Women

Status:	Recruiting
Conditions:	Migraine Headaches
Therapuetic Areas:	Neurology
Healthy:	No
Age Range:	18 - 35
Updated:	10/27/2018
Start Date:	April 1, 2017
End Date:	March 2020
Contact:	Anna DeDio, MPH
Email:	MigraineDietStudy@email.chop.edu
Phone:	(267) 425-1998

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.

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

We found this trial at

sites

Univ of Pennsylvania

3451 Walnut St
Philadelphia, Pennsylvania 19104

1 (215) 898-5000