Effect of Peripheral Electrical Stimulation (PES) on Brain Response to Glucose Stimuli

Sponsor

Tel Aviv University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02969330

Collaborator

Sheba Medical Center (Other)

Enrollment

Arms

Study Details

Study Description

Brief Summary

The aims of this study are twofold: (1) to develop an innovative approach for studying brain glucose metabolism using functional diffusion weighted imaging (DWI) and BOLD fMRI in humans; (2) to evaluate the effect of short peripheral electrical stimulation (PES) treatment on brain and brain-stem targets, associated with control of food intake and energy expenditure, in response to glucose stimuli, in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Brain Activity Glucose Control	Device: Stimulator Dietary Supplement: Glucose	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Effect of Short Peripheral Electrical Stimulation (PES) on Brain Response to Glucose Stimuli Evaluated by BOLD and Functional Diffusion MRI: a Crossover Pilot Study

Study Start Date :

Dec 1, 2016

Anticipated Primary Completion Date :

Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Glucose Glucose ingestion	Dietary Supplement: Glucose 300ml tap water with 75g glucose
Active Comparator: PES Single session of short PES treatment before glucose ingestion.	Device: Stimulator Dietary Supplement: Glucose 300ml tap water with 75g glucose

Arm

Intervention/Treatment

Experimental: Glucose

Glucose ingestion

Dietary Supplement: Glucose

300ml tap water with 75g glucose

Active Comparator: PES

Single session of short PES treatment before glucose ingestion.

Device: Stimulator

Dietary Supplement: Glucose

300ml tap water with 75g glucose

Outcome Measures

Primary Outcome Measures

Changes in postprandial cerebral blood flow (fMRI) and cerebral diffusivity (fDWI) in response to glucose ingestion. [changes from baseline to 30 minutes after glucose ingestion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy volunteers
Age 18-65 years old.
Body mass index 18 to 25 kg/m2
Capable of giving informed consent

Exclusion Criteria:

Pregnancy, or nursing
Permanent pacemakers
Metal prosthesis
Skin disease
Claustrophobia
History of neurological disorders

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tel Aviv University
Sheba Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Uri Nevo, PhD, Tel Aviv University

ClinicalTrials.gov Identifier:

NCT02969330

Other Study ID Numbers:

2366-16-SMC

First Posted:

Nov 21, 2016

Last Update Posted:

Nov 21, 2016

Last Verified:

Nov 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of Nov 21, 2016