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Migraine and Body Composition

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Drs Barbara Peterlin, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01720862
First received: October 31, 2012
Last updated: October 17, 2014
Last verified: October 2012
  Purpose

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


Condition
Migraine With and Without Aura
Chronic Migraine
Healthy Controls

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Migraine and Body Composition

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • association between migraine and obesity - evaluate serum adipokine levels [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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:
  • association between migraine and obesity -evaluate subcutaneous adipose tissue (SAT) and its ratio to visceral adipose tissue (VAT) [ Time Frame: five years ] [ Designated as safety issue: No ]
    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

serum


Estimated Enrollment: 300
Study Start Date: April 2012
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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.

Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720862

Contacts
Contact: Barbara L Peterlin, D.O. 410-550-9550 lpeterlin@jhmi.edu
Contact: Linda W White, CRNP 410-550-4418 lwhite@jhmi.edu

Locations
United States, Maryland
The Johns Hopkins Bayview Headache Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Barbara L Peterlin, D.O.    410-550-9550    lpeterlin@jhmi.edu   
Contact: Linda W White, CRNP    410-550-4418    lwhite@jhmi.edu   
Principal Investigator: Barbara L Peterlin, DO         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Barbara L Peterlin, DO Johns Hopkins University
  More Information

No publications provided

Responsible Party: Drs Barbara Peterlin, Director of Headache Research, Johns Hopkins Bayview, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01720862     History of Changes
Other Study ID Numbers: NA_00051683
Study First Received: October 31, 2012
Last Updated: October 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
migraine
episodic migraine
chronic migraine
obesity
non-obese

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

ClinicalTrials.gov processed this record on November 25, 2014