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

NCT ID: NCT02969330

Last Updated: 2016-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Activity Glucose Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Glucose

Glucose ingestion

Group Type EXPERIMENTAL

Glucose

Intervention Type DIETARY_SUPPLEMENT

300ml tap water with 75g glucose

PES

Single session of short PES treatment before glucose ingestion.

Group Type ACTIVE_COMPARATOR

Stimulator

Intervention Type DEVICE

Glucose

Intervention Type DIETARY_SUPPLEMENT

300ml tap water with 75g glucose

Interventions

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Stimulator

Intervention Type DEVICE

Glucose

300ml tap water with 75g glucose

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role collaborator

Tel Aviv University

OTHER

Sponsor Role lead

Responsible Party

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Uri Nevo

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Uri Nevo, PhD

Role: CONTACT

Phone: 972-3-6407542

Email: [email protected]

Other Identifiers

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2366-16-SMC

Identifier Type: -

Identifier Source: org_study_id