Migraine and Body Composition

NCT ID: NCT01720862

Last Updated: 2016-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-10-31

Brief Summary

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This research is being done to look at the association between migraine and obesity.

Detailed Description

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Research into the role of inflammatory markers and other obesity related proteins and chemicals may help us understand migraine and lead to new treatment.

Conditions

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Migraine With and Without Aura Chronic Migraine Healthy Controls

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Episodic migraineurs

Those with migraines \>2 and \< 12 times per month.

No interventions assigned to this group

Chronic migraineurs

Those with migraines greater than 14 days per month.

No interventions assigned to this group

Controls

Those without headaches other than occasional hangover, cold, flu headaches.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Drs Barbara Peterlin

Director of Headache Research, Johns Hopkins Bayview

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara L Peterlin, DO

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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The Johns Hopkins Bayview Headache Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA_00051683

Identifier Type: -

Identifier Source: org_study_id

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