Migraine and Body Composition

Completed

• Conditions: Migraine With and Without Aura; Chronic Migraine; Healthy Controls

• Registration Number: NCT01720862
• Lead Sponsor: Johns Hopkins University

Brief Summary

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 Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2012-11-01
• Study First Posted: 2012-11-02
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
association between migraine and obesity - evaluate serum adipokine levels	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

Name	Time	Method
association between migraine and obesity -evaluate subcutaneous adipose tissue (SAT) and its ratio to visceral adipose tissue (VAT)	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.

Trial Locations

Locations (1)

The Johns Hopkins Bayview Headache Center; 🇺🇸 Baltimore, Maryland, United States