MigraineNCT03081390
Migraine and CVD Risk in Women
A study testing Mixed meal tolerance testing, Skin conductance & cold pressor test and Flow-mediated dilation testing in people with Migraine, run by University of Pennsylvania at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Mixed meal tolerance testing, Skin conductance & cold pressor test and Flow-mediated dilation testing
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2017to 28 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female 18-35 years of age, inclusive
- BMI 18.5-24.9 kg/m2, inclusive
- BMI ≥30 kg/m2
- Diagnosis of migraine per ICHD-3-beta (1-10 migraine days per month)
Who cannot join
- 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
Show all 9Show fewer
- Treatment with antibiotics or steroids within the previous 3 months
- Treatment with NSAIDs within the previous 1 week
- Migraine headaches, or headaches other than tension-type headaches with a frequency of 1 or fewer days per month
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pennsylvania
Philadelphia, Pennsylvania, 19004
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
- Conditions
- Migraine
- Being tested
- Mixed meal tolerance testing, Skin conductance & cold pressor test, Flow-mediated dilation testing
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed meal tolerance testingOther
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 testOther
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 testingOther
At baseline and post-meal, we will assess flow-mediated dilation at the brachial artery using well-validated ultrasound techniques.
| Study group | Role | What they receive |
|---|---|---|
| No migraine, normal weight | Experimental | * Mixed meal tolerance testing
* Skin conductance \& cold pressor test
* Flow-mediated dilation testing Receives: Other: Mixed meal tolerance testing; Other: Skin conductance & cold pressor test; Other: Flow-mediated dilation testing |
| No migraine, obese | Experimental | * Mixed meal tolerance testing
* Skin conductance \& cold pressor test
* Flow-mediated dilation testing Receives: Other: Mixed meal tolerance testing; Other: Skin conductance & cold pressor test; Other: Flow-mediated dilation testing |
| Migraine, normal weight | Experimental | * Mixed meal tolerance testing
* Skin conductance \& cold pressor test
* Flow-mediated dilation testing Receives: Other: Mixed meal tolerance testing; Other: Skin conductance & cold pressor test; Other: Flow-mediated dilation testing |
| Migraine, obese | Experimental | * Mixed meal tolerance testing
* Skin conductance \& cold pressor test
* Flow-mediated dilation testing Receives: Other: Mixed meal tolerance testing; Other: Skin conductance & cold pressor test; Other: Flow-mediated dilation testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
LPS area under the curve (AUC)
The primary study endpoint is lipopolysaccharide (LPS) area under the curve (AUC) during MMTT.
Measured: LPS is measured at baseline every 30 minutes for 4 hours.
Secondary outcomes (2)
Flow-mediated dilation (FMD)
Vascular reactivity via brachial artery ultrasound, expressed as flow-mediated dilation (% of baseline diameter, normalized).
Measured: FMD is measured at baseline and 2.5 hours after MMTT.
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).
Measured: Sympathetic tone at rest and with painful stimulus are measured at baseline and 3 hours after MMTT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start1 Apr 2017
- Primary completion28 Sep 2026
- Study completion28 Sep 2026
Why it stopped: Investigator transition
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shana E McCormack, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081390
- Sponsor's protocol ID
- 826251
- Status last verified
- Oct 2026
- First submitted
- 16 Feb 2017
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Increased Cardiovascular Disease Risk in Women With Migraine
- ClinicalTrials.gov ID
- NCT03081390
- Acronym / sponsor ID
- 826251
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator transition
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 28 Sep 2026 (actual)
- Study completion
- 28 Sep 2026 (actual)
- First posted
- 16 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| No migraine, normal weight | Experimental | Other: Mixed meal tolerance testing, Other: Skin conductance & cold pressor test, Other: Flow-mediated dilation testing* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing |
| No migraine, obese | Experimental | Other: Mixed meal tolerance testing, Other: Skin conductance & cold pressor test, Other: Flow-mediated dilation testing* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing |
| Migraine, normal weight | Experimental | Other: Mixed meal tolerance testing, Other: Skin conductance & cold pressor test, Other: Flow-mediated dilation testing* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing |
| Migraine, obese | Experimental | Other: Mixed meal tolerance testing, Other: Skin conductance & cold pressor test, Other: Flow-mediated dilation testing* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female 18-35 years of age, inclusive
- BMI 18.5-24.9 kg/m2, inclusive
- BMI ≥30 kg/m2
- Diagnosis of migraine per ICHD-3-beta (1-10 migraine days per month)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed meal tolerance testingAn 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 | Migraine, normal weight, Migraine, obese, No migraine, normal weight, No migraine, obese |
| Skin conductance & cold pressor testSkin 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 | Migraine, normal weight, Migraine, obese, No migraine, normal weight, No migraine, obese |
| Flow-mediated dilation testingAt baseline and post-meal, we will assess flow-mediated dilation at the brachial artery using well-validated ultrasound techniques. | Other | Migraine, normal weight, Migraine, obese, No migraine, normal weight, No migraine, obese |
Primary outcome
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.
2 secondary outcomes
Flow-mediated dilation (FMD)
Time frame: 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.
Results and safety
The study was stopped early (reason given: Investigator transition). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shana E McCormack, MD principal investigator
Children's Hospital of Philadelphia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed meal tolerance testing, Skin conductance & cold pressor test and Flow-mediated dilation testing in people with Migraine, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigator transition). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LPS area under the curve (AUC) (time frame: LPS is measured at baseline every 30 minutes for 4 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.