How Does Vagus Nerve Stimulation Affect Blood Glucose, Food, and Movement Cravings?
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Mark Hartman, PhD
- Phone Number: 218-726-7275
- Email: hartm373@d.umn.edu
Study Locations
-
-
Minnesota
-
Duluth, Minnesota, United States, 55812
- University of Minnesota Duluth
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants must be between the ages of 18 and 35 as we are focused on recruiting undergraduate and graduate students.
Exclusion Criteria:
- Participants will be excluded if they have epilepsy, clinically significant tachycardia or arrhythmia, diabetes (Type 1 or Type 2) or another metabolic disease, current pregnancy, any implanted electronic medical device (for example, pacemaker or defibrillator), or a known skin allergy to adhesives that would prevent CGM placement. Participants will also be excluded if they have a history of major depressive disorder if taVNS could reasonably be expected to alter mood symptoms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Active taVNS
|
Actual taVNS
|
|
Placebo Comparator: Sham taVNS
|
No nerve stimulation
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in plasma glucose
Time Frame: Hour 2 after oral glucose load
|
Hour 2 after oral glucose load
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Mark Hartman, PhD, University of Minnesota
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- taVNS Study 2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.