NCT02969330

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

1.1 years

First QC Date

November 17, 2016

Last Update Submit

November 17, 2016

Conditions

Brain ActivityGlucose Control

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Glucose

EXPERIMENTAL

Glucose ingestion

Dietary Supplement: Glucose

PES

ACTIVE COMPARATOR

Single session of short PES treatment before glucose ingestion.

Device: StimulatorDietary Supplement: Glucose

Interventions

StimulatorDEVICE
PES
GlucoseDIETARY_SUPPLEMENT

300ml tap water with 75g glucose

GlucosePES

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Tissue Therapy, HistoricalGlucose

Intervention Hierarchy (Ancestors)

OrganotherapyBiological TherapyTherapeuticsComplementary TherapiesHexosesMonosaccharidesSugarsCarbohydrates

Central Study Contacts

Uri Nevo, PhD

CONTACT

972-3-6407542nevouri@post.tau.ac.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 17, 2016

First Posted

November 21, 2016

Study Start

December 1, 2016

Primary Completion

January 1, 2018

Last Updated

November 21, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share