Migraine and Body Composition

NCT01720862 | Completed

• 1 other identifier: NA_00051683
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Migraine With and Without Aura; Chronic Migraine; Healthy Controls

Keywords

migraine; episodic migraine; chronic migraine; obesity; non-obese

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• association between migraine and obesity -evaluate subcutaneous adipose tissue (SAT) and its ratio to visceral adipose tissue (VAT)

  five years

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Premenopausal Caucasian women ages 18-55 years with or without migraine.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

The Johns Hopkins Bayview Headache Center

Baltimore, Maryland, 21224, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Migraine Disorders; Obesity

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Barbara L Peterlin, DO

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Headache Research, Johns Hopkins Bayview

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: November 2, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

US (1)