Migraine and Body Composition

Chronic Migraine Clinical Trial

Official title:

Migraine and Body Composition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720862
• Other study ID #: NA_00051683
• Status: Completed
• Phase: N/A
• First received: October 31, 2012
• Last updated: January 27, 2016
• Start date: April 2012
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Migraine
• Healthy Controls
• Migraine Disorders
• Migraine With and Without Aura

Locations

Country	Name	City	State
United States	The Johns Hopkins Bayview Headache Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years	No
Secondary	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.	five years	No