Migraine and Homeostasis:What Can we Learn From Glucose

Beth Israel Lahey Health

Status: Terminated

Conditions: Migraine Headache

Treatments: Other: Luna Bar

Study type: Interventional

Funder types: Other

Identifiers

NCT03097536

2015P000419

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Luna Bar Intervention

Experimental group

Description:

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.

Treatment:

Other: Luna Bar

Morning Migraine

No Intervention group

Description:

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.