Migraine and Homeostasis:What Can we Learn From Glucose

NCT03097536 | Terminated

• 1 other identifier: 2015P000419
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Headache

Keywords

Blood Sugar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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.

  Change Measure: migraine days and non-migraine days over 3 month period.

Study Arms (2)

Luna Bar Intervention

EXPERIMENTAL

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

Morning Migraine

NO INTERVENTION

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.

Interventions

Luna Bar OTHER

Luna Bar (blueberry bliss or lemon zest flavor) product of Clif

Luna Bar Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medial Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Alexandra Hovaguimian, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Neurology

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: March 31, 2017
• Study Start: March 1, 2016
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

US (1)