Migraine and Homeostasis:What Can we Learn From Glucose

• ClinicalTrials.gov Identifier: NCT03097536
• Recruitment Status: Recruiting
• First Posted: March 31, 2017
• Last Update Posted: July 22, 2021
• Sponsor: Beth Israel Deaconess Medical Center
• Information provided by (Responsible Party): Alexandra Hovaguimian, Beth Israel Deaconess Medical Center

Study Description

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 Design

• 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 2023
• Estimated Study Completion Date: January 2024

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

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: Keishi Nambara, BA 617-667-0317 knambara@bidmc.harvard.edu

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

• Principal Investigator: Alexandra Hovaguimian, MD; Beth Israel Deaconess Medical Center

More Information

• Responsible Party: Alexandra Hovaguimian, Instructor in Neurology, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT03097536
• Other Study ID Numbers: 2015P000419
• First Posted: March 31, 2017
• Last Update Posted: July 22, 2021
• Last Verified: July 2021

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