Migraine and Body Composition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01720862
Recruitment Status : Completed
First Posted : November 2, 2012
Last Update Posted : January 28, 2016
Information provided by (Responsible Party):
Drs Barbara Peterlin, Johns Hopkins University

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

Condition or disease
Migraine With and Without Aura Chronic Migraine Healthy Controls

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 Type : Observational
Actual Enrollment : 300 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Migraine and Body Composition
Study Start Date : April 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Episodic migraineurs
Those with migraines >2 and < 12 times per month.
Chronic migraineurs
Those with migraines greater than 14 days per month.
Those without headaches other than occasional hangover, cold, flu headaches.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. association between migraine and obesity -evaluate subcutaneous adipose tissue (SAT) and its ratio to visceral adipose tissue (VAT) [ Time Frame: five years ]
    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.

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Premenopausal Caucasian women ages 18-55 years with or without migraine.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01720862

United States, Maryland
The Johns Hopkins Bayview Headache Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Barbara L Peterlin, DO Johns Hopkins University

Responsible Party: Drs Barbara Peterlin, Director of Headache Research, Johns Hopkins Bayview, Johns Hopkins University Identifier: NCT01720862     History of Changes
Other Study ID Numbers: NA_00051683
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Drs Barbara Peterlin, Johns Hopkins University:
episodic migraine
chronic migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases