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OpenTrials
Completed

NCT Number: NCT01720862

Migraine and Body Composition

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

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Key information

Conditions

Migraine With and Without Aura Body Weight Brain Diseases Central Nervous System Diseases Chronic Migraine Headache Disorders Headache Disorders, Primary Healthy Controls Migraine Disorders Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

The Johns Hopkins Bayview Headache Center

Baltimore, Maryland, 21224, United States

About this study

Research into the role of inflammatory markers and other obesity related proteins and chemicals may help us understand migraine and lead to new treatment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 2, 2012
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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