Migraine and Homeostasis:What Can we Learn From Glucose

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Migraine and Homeostasis:What Can we Learn From Glucose

Conditions
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Migraine Headache

Intervention / Treatment
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* Other: Luna Bar


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Luna Bar Intervention<br>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<br>* Luna Bar (blueberry bliss or lemon zest flavor) product of Clif<br>|
| No Intervention: Morning Migraine<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in blood glucose on days with migraine compared to blood glucose on days without migraine | 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 | Change Measure: migraine days and non-migraine days over 3 month period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | Change Measure: migraine days and non-migraine days over 3 month period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Sugar