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
|Condition or disease||Intervention/treatment||Phase|
|Migraine Headache||Other: Luna Bar||Not Applicable|
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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
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
|Contact: Alexandra Hovaguimian, MDfirstname.lastname@example.org|
|Contact: Shaelah Huntington, BAemail@example.com|
|United States, Massachusetts|
|Beth Israel Deaconess Medial Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Shaelah Huntington, BA 617-667-0317 firstname.lastname@example.org|
|Principal Investigator:||Alexandra Hovaguimian, MD||Beth Israel Deaconess Medical Center|