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Migraine and Homeostasis:What Can we Learn From Glucose

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ClinicalTrials.gov Identifier: NCT03097536
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Alexandra Hovaguimian, Beth Israel Deaconess Medical Center

Brief Summary:
Patients with migraine often report that stressors such as skipping a meal can bring on a migraine whereas some patients report that their migraine improves with food. Few studies to date have looked at the relationship between blood glucose (sugar) and migraine. We are conducting this study to better understand whether or not changes in blood glucose levels can trigger migraine or provide relief during a migraine attack.

Condition or disease Intervention/treatment Phase
Migraine Headache Other: Luna Bar Not Applicable

Detailed Description:

The purpose of this pilot and feasibility study is to assess if changes in blood glucose both trigger migraine and can provide analgesia. This information will provide a vital basis for the mechanism of migraine and offer insights into better treatments as well as prevention.

This is a pilot unblinded randomized trial with two independent components, Aims 1 and 2. It is not possible to blind the current protocol both in terms of the blood sugar readings and the luna bar, non-luna bar intervention.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Migraine and Homeostasis:What Can we Learn From Glucose
Study Start Date : March 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Luna Bar Intervention
Participants will be asked to monitor their blood sugar during migraine. Study data will also include blood glucose levels, pain severity, 24-hour food diary, 24-hour exercise diary, duration of sleep, perception of quality of sleep, and last menstrual period. This information will be recorded at times when a Luna bar is not consumed, and at times when a Luna Bar is consumed. Participants will serve as their own controls.
Other: Luna Bar
Luna Bar (blueberry bliss or lemon zest flavor) product of Clif

No Intervention: Morning Migraine
Participants will be asked to monitor their blood sugar on headache free days as well as during migraine. This arm is only for participants who identify as having morning migraine. Study data will also include blood glucose levels, pain severity, 24-hour food diary, 24-hour exercise diary, duration of sleep, perception of quality of sleep, and last menstrual period. Participants will serve as their own controls.



Primary Outcome Measures :
  1. The difference in blood glucose on days with migraine compared to blood glucose on days without migraine [ Time Frame: Change Measure: migraine days and non-migraine days over 3 month period. ]
    The primary endpoint will be the difference in blood glucose on days with migraine compared to blood glucose on days without migraine using repeated measure ANOVA


Secondary Outcome Measures :
  1. The primary outcome is the change in pain score from the time of pain plateau to the pain score at 120 minutes as measured by a visual analogue scale. [ Time Frame: Change Measure: migraine days and non-migraine days over 3 month period. ]
    The primary outcome is the change in pain score from the time the patients pain plateaus (as measured by having a stable pain score for 60 minutes) compared to the pain score at 120 minutes using a repeated measures ANOVA. We will compare these measures on migraine days with Luna and without Luna bar (control days) using a repeated measures ANOVA



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female participants, age 18-65 with episodic migraine with or without aura (ICHD-II) and/or morning onset and/or patients who self identify that eating reduces their migraine intensity.

Exclusion Criteria:

  • Chronic migraine, use of hypoglycemic medication, DM I or II, abnormal finger stick glucose, obesity, comorbid eating disorders, pregnancy, seizure disorder, other serious mental or physical condition that would impair participation in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03097536


Contacts
Contact: Alexandra Hovaguimian, MD ahovagui@bidmc.harvard.edu
Contact: Shaelah Huntington, BA 617-667-0317 shunting@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medial Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Shaelah Huntington, BA    617-667-0317    shunting@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Alexandra Hovaguimian, MD Beth Israel Deaconess Medical Center

Responsible Party: Alexandra Hovaguimian, Instructor in Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03097536     History of Changes
Other Study ID Numbers: 2015P000419
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexandra Hovaguimian, Beth Israel Deaconess Medical Center:
Blood Sugar

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms