Migraine With and Without AuraNCT01720862
Migraine and Body Composition
An observational study of Migraine With and Without Aura and Chronic Migraine, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to look at the association between migraine and obesity. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Migraine With and Without Aura, Chronic Migraine, Healthy Controls
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Oct 2015
- Phase
- Observational
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Premenopausal Caucasian women ages 18-55 years with or without migraine.
Who may be able to join
- Premenopausal women (18-55 years)
- Normal weight (BMI = 18.5 - 24.9) or obese (BMI ≥ 30)
- Diagnosis of episodic or chronic migraine or pain free control
Who cannot join
- Evidence of pain disorder other than migraine (e.g. irritable bowel syndrome)
- Chronic conditions known to alter risk or pattern of migraine (e.g. hypothyroidism)
- Illnesses that may affect adipokine levels (e.g. diabetes)
- Clinically relevant abnormal glucose/cholesterol levels
- Pregnant women
- Potential participants who are unable to undergo MRI based on standard screening questionnaire (those with brain aneurysm or surgical clips, certain types of artificial heart valves, heart defibrillator or pacemaker, cochlear implants, eye implants, blood vessel coil, recently placed artificial joints, certain types of vascular stents, history of bullets, pellets, BBs, history of any implanted metal or device or who have worked with sheet metal in the past)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Bayview Headache Center
Baltimore, Maryland, 21224
About this study
This research is being done to look at the association between migraine and obesity.
Read the detailed description
Research into the role of inflammatory markers and other obesity related proteins and chemicals may help us understand migraine and lead to new treatment.
- Keywords
- migraine, episodic migraine, chronic migraine, obesity, non-obese
- Medical subject headings
- Migraine Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Episodic migraineurs | Those with migraines >2 and < 12 times per month. | |
| Chronic migraineurs | Those with migraines greater than 14 days per month. | |
| Controls | Those without headaches other than occasional hangover, cold, flu headaches. |
What is being measured
The primary outcome is the main question the study is designed to answer.
association between migraine and obesity - evaluate serum adipokine levels
The first aim of the proposed research is to evaluate serum adipokine levels in a clinical cohort of obese and non-obese episodic and chronic migraineurs and examine their utility as markers of the presence or absence of migraine and their relationship to headache frequency.
Measured: 5 years
Secondary outcomes (1)
association between migraine and obesity -evaluate subcutaneous adipose tissue (SAT) and its ratio to visceral adipose tissue (VAT)
The second aim of the proposed research is to evaluate subcutaneous adipose tissue (SAT) and its ratio to visceral adipose tissue (VAT),in the same clinical cohort of migraineurs to determine if regional adipose tissue differences exist between: (1) episodic migraineurs, (2) chronic migraineurs and (3) controls, thus contributing to the migraine-obesity relationship.
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine With and Without AuraStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Drs Barbara Peterlin, Johns Hopkins University
- Investigators
- Barbara L Peterlin, DO, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720862
- Sponsor's protocol ID
- NA_00051683
- Status last verified
- Jan 2016
- First submitted
- 31 Oct 2012
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migraine and Body Composition
- ClinicalTrials.gov ID
- NCT01720862
- Acronym / sponsor ID
- NA_00051683
- Keywords
- migraine, episodic migraine, chronic migraine, obesity, non-obese
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 Nov 2012 (estimated)
- 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.
This research is being done to look at the association between migraine and obesity.
Detailed description
Research into the role of inflammatory markers and other obesity related proteins and chemicals may help us understand migraine and lead to new treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Episodic migraineurs | – | –Those with migraines >2 and < 12 times per month. |
| Chronic migraineurs | – | –Those with migraines greater than 14 days per month. |
| Controls | – | –Those without headaches other than occasional hangover, cold, flu headaches. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Premenopausal Caucasian women ages 18-55 years with or without migraine.
Key inclusion criteria (3 listed)
- Premenopausal women (18-55 years)
- Normal weight (BMI = 18.5 - 24.9) or obese (BMI ≥ 30)
- Diagnosis of episodic or chronic migraine or pain free control
Key exclusion criteria (6 listed)
- Evidence of pain disorder other than migraine (e.g. irritable bowel syndrome)
- Chronic conditions known to alter risk or pattern of migraine (e.g. hypothyroidism)
- Illnesses that may affect adipokine levels (e.g. diabetes)
- Clinically relevant abnormal glucose/cholesterol levels
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
association between migraine and obesity - evaluate serum adipokine levels
Time frame: 5 years
The first aim of the proposed research is to evaluate serum adipokine levels in a clinical cohort of obese and non-obese episodic and chronic migraineurs and examine their utility as markers of the presence or absence of migraine and their relationship to headache frequency.
1 secondary outcome
association between migraine and obesity -evaluate subcutaneous adipose tissue (SAT) and its ratio to visceral adipose tissue (VAT)
Time frame: five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
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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.
Barbara L Peterlin, DO principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine With and Without Aura and Chronic Migraine, run by Johns Hopkins University at 1 site 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
association between migraine and obesity - evaluate serum adipokine levels (time frame: 5 years). 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 28 Jan 2016.