Glucose Metabolism DisordersNCT04031404

Glucose and Non-Invasive Brain Stimulation

A study testing Single-pulse TMS in people with Glucose Metabolism Disorders, run by University of North Carolina, Chapel Hill at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Purpose: In this study, the investigators will delineate how brain network dynamics are modulated by experimentally induced elevated blood glucose levels and examine how glucose levels gate neuronal excitability measured by the response to TMS. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Glucose Metabolism Disorders
What is being tested?: Single-pulse TMS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: 11 Sep 2019to 31 Aug 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Right-handed
BMI <30
Free of major neurological conditions and diabetes

Who cannot join

Diabetes
Adverse reaction to finger prick blood draw
Known neurological or psychiatric illness
Prior brain surgery
Any brain devices/implants, including cochlear implants and aneurysm clips
Cardiac pacemaker

Show all 9Show fewer

Any other implanted electronic device
History of current traumatic brain injury
Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

UNC Medical School Wing C
Chapel Hill, North Carolina, 27514

Other trials in United States

About this study

Official title: Modulation of Motor Cortex Excitability by Glucose Administration

Participants: Participants must be between the ages of 18 and 65 with no known diabetes, no known adverse reaction to finger prick blood draw, and no known neurological or psychiatric illness. Participants must have a body-mass index less than 30.

Procedures: Participants will consume either a drink that contains 75 g of glucose or a placebo, and their response to TMS will be measured to examine the effect of glucose on motor cortex excitability.

Read the detailed description

This study will be a placebo-controlled study that investigates brain function with both electroencephalography (EEG) and TMS. On each study visit, a drink (either glucose drink or water) is administered after baseline assessment of fasting glucose. Changes in brain activity and excitability will be measured with resting-state EEG. Periodic high-density EEG of resting-state brain activity and activity during a working memory task will be performed before the administration of the drink, immediately after the administration of the drink, as well as 30 minutes, 60 minutes, 120 minutes, 150 minutes, and 180 minutes after the administration of the drink. The spectral content of the EEG signal will be investigated to identify the relative presence of cortical oscillations. Primarily, there will be a focus on theta (4-8 Hz) and alpha (8-12 Hz) oscillations.

Previous literature indicates that theta and alpha oscillations represent an engaged and disengaged cortical state, respectively [1]. Alpha and theta oscillations are implicated in cognitive function and are altered in depression. Therefore, this study aims to identify a decrease in frontal theta oscillations and an increase in left frontal alpha oscillations, two defining features of impaired top-down control and mood regulation, in response to the glucose drink contrasted with the response to the placebo.

The study will also examine how glucose levels gate neuronal excitability measured by the response to TMS. Cortical excitability will be measured by applying TMS pulses to the motor cortex and measuring the response in the form of a motor evoked potential by electromyography (EMG). TMS will be applied before the administration of the drink, immediately after the administration of the drink, as well as 30 minutes, 60 minutes, 120 minutes, 150 minutes, and 180 minutes after the administration of the drink. Changes in blood glucose will be monitored over this time interval as well.

Conditions: Glucose Metabolism Disorders
Being tested: Single-pulse TMS
Medical subject headings: Glucose Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Single-pulse TMSDevice
Also called MagPro X100
Single-pulse transcranial magnetic stimulation (TMS) on the motor cortex will lead to a twitch in the target muscle and evoke a motor-evoked potential (MEP) measured by electromyography (EMG).

Study groups in NCT04031404
Study group	Role	What they receive
Glucose drink followed by placebo	Experimental	Participants will consume the glucose drink at session 1, then they will consume the placebo (water) at session 2. Receives: Device: Single-pulse TMS
Placebo followed by glucose drink	Experimental	Participants will consume the placebo (water) at session 1, then they will consume the glucose drink at session 2. Receives: Device: Single-pulse TMS

What is being measured

The primary outcome is the main question the study is designed to answer.

Motor Evoked Potential (MEP)
Change in MEP over time to indicate changes in motor cortex excitability
Measured: Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.
TMS Evoked Potential (TEP)
The TMS Evoked Potential (TEP) is the difference in microvolts from 25 milliseconds after a TMS pulse versus pre-TMS such that greater values indicate greater motor cortex excitability. The measure of the change in TEP over time since either glucose or water was consumed approximates a z-distribution with a range of -20 to 20 with central distribution measures of zero. TEPs were source localized and reported using a pseudo-neural activity index (PNAI) expressing source activation in relation to pre-TMS pulse trial baseline. The difference in the source peaks corresponding to the early P25 component have been reported as differences from baseline. Higher values indicate greater cortical excitation, consistent with the study hypothesis.
Measured: Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.

Secondary outcomes (3)

EEG Measure of Alpha Asymmetry Oscillations
Electroencephalography will be used to measure the change in lateralized alpha asymmetry (10-12 Hz electrical activity) over time
Measured: Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.
EEG Measure of Frontal Midline Theta Oscillations
Electroencephalography will be used to measure the change in frontal midline theta power (5-8 Hz electrical activity) over time
Measured: Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.
Working Memory Task Accuracy
This outcome will analyze the change in accuracy in a computerized working memory task over time. During the task, subjects will be presented with an array of colored squares. Then, they will need to hold this array in mind during a delay period. Finally, participants will be tested on their memory of the array by responding whether a presented color is the same or different as the corresponding square in the first array. Participants' accuracy will be expressed as the percentage of correct responses (from 0% correct responses to 100% correct responses). An accuracy rate of 50% indicates that the participant is performing at the same accuracy level as random chance.
Measured: Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 201931 Aug 2020

First posted24 Jul 2019
Study start11 Sep 2019
Primary completion31 Aug 2020
Study completion31 Aug 2020

Why it stopped: COVID-19 Pandemic

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Glucose Metabolism DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04031404
Sponsor's protocol ID: 19-1451
Status last verified: Aug 2021
First submitted: 18 Jul 2019
Last updated: 27 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Publications

Stitt I, Zhou ZC, Radtke-Schuller S, Frohlich F. Arousal dependent modulation of thalamo-cortical functional interaction. Nat Commun. 2018 Jun 25;9(1):2455. doi: 10.1038/s41467-018-04785-6.
PubMed 29941957

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glucose Metabolism Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Modulation of Motor Cortex Excitability by Glucose Administration
ClinicalTrials.gov ID: NCT04031404
Acronym / sponsor ID: 19-1451
Conditions: Glucose Metabolism Disorders
Study type: Interventional
Recruitment status: TerminatedReason stopped: COVID-19 Pandemic
Enrolment: 23 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 11 Sep 2019 (actual)
Primary completion: 31 Aug 2020 (actual)
Study completion: 31 Aug 2020 (actual)
First posted: 24 Jul 2019 (actual)
Results: Posted 27 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Glucose drink followed by placebo	Experimental	Device: Single-pulse TMSParticipants will consume the glucose drink at session 1, then they will consume the placebo (water) at session 2.
Placebo followed by glucose drink	Experimental	Device: Single-pulse TMSParticipants will consume the placebo (water) at session 1, then they will consume the glucose drink at session 2.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Right-handed
BMI <30
Free of major neurological conditions and diabetes

Key exclusion criteria (9 listed)

Diabetes
Adverse reaction to finger prick blood draw
Known neurological or psychiatric illness
Prior brain surgery
Any brain devices/implants, including cochlear implants and aneurysm clips

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Single-pulse TMSAlso: MagPro X100Single-pulse transcranial magnetic stimulation (TMS) on the motor cortex will lead to a twitch in the target muscle and evoke a motor-evoked potential (MEP) measured by electromyography (EMG).	Device	Glucose drink followed by placebo, Placebo followed by glucose drink

Primary outcome

Motor Evoked Potential (MEP)
Time frame: Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.
Change in MEP over time to indicate changes in motor cortex excitability
TMS Evoked Potential (TEP)
Time frame: Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.
The TMS Evoked Potential (TEP) is the difference in microvolts from 25 milliseconds after a TMS pulse versus pre-TMS such that greater values indicate greater motor cortex excitability. The measure of the change in TEP over time since either glucose or water was consumed approximates a z-distribution with a range of -20 to 20 with central distribution measures of zero. TEPs were source localized and reported using a pseudo-neural activity index (PNAI) expressing source activation in relation to pre-TMS pulse trial baseline. The difference in the source peaks corresponding to the early P25 component have been reported as differences from baseline. Higher values indicate greater cortical excitation, consistent with the study hypothesis.

3 secondary outcomes

EEG Measure of Alpha Asymmetry Oscillations
Time frame: Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.
EEG Measure of Frontal Midline Theta Oscillations
Time frame: Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.
Working Memory Task Accuracy
Time frame: Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.

Results and safety

Results posted to the registry on 27 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Glucose Drink Followed by Placebo	10	8
Placebo Followed by Glucose Drink	13	8

Primary outcome: Motor Evoked Potential (MEP)

Time frame: Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.. Mean (Standard Error). Unit: log10(Post uV/Baseline uV)

Measure	MEP After Glucose Drink n = 7	MEP After Placebo Drink n = 7
MEP change (0 min vs pre-drink)	0.14 (0.15)	-0.25 (0.07)
MEP change (30 min vs pre-drink)	-0.02 (0.19)	-0.12 (0.11)
MEP change (60 min vs pre-drink)	-0.08 (0.14)	-0.33 (0.10)
MEP change (120 min vs pre-drink)	-0.05 (0.16)	-0.25 (0.09)
MEP change (180 min vs pre-drink)	-0.21 (0.18)	-0.18 (0.10)

Population analysed: From the 10 participants who completed, 3 were excluded from the analysis due to technical reasons. Two participants had to end their glucose visits early due to scheduling conflicts. The reported N below is adjusted where appropriate.

Primary outcome: TMS Evoked Potential (TEP)

Time frame: Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.. Mean (Standard Error). Unit: z-score

Measure	Source-localized TEP After Glucose Drink n = 7	Source-localized TEP After Placebo Drink n = 7
TEP change (P25: 0 min vs pre-drink)	-0.04 (0.08)	0.28 (0.16)
TEP change (P25: 30 min vs pre-drink)	-0.11 (0.11)	0.024 (0.05)
TEP change (P25: 60 min vs pre-drink)	-0.16 (0.11)	0.30 (0.06)
TEP change (P25: 120 min vs pre-drink)	-0.16 (0.12)	0.24 (0.07)
TEP change (P25: 180 min vs pre-drink)	0.08 (0.08)	0.02 (0.15)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 2 months per participant. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TMS-EEG After Glucose Drink	0 of 11 (0%)	10 of 11 (90.9%)	0 of 11
TMS-EEG After Placebo Drink	0 of 10 (0%)	8 of 10 (80%)	0 of 10

Limitations and caveats (from the sponsor): The end sample sizes are lower than intended as the trial was ended early due to COVID-19-related research drawdowns. Technical limitations in the Electroencephalogram (EEG) and Transcranial Magnetic Stimulation (TMS) data collection resulted in N=1 and N=3 dataset to be excluded from final analyses, respectively.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29941957Stitt I, Zhou ZC, Radtke-Schuller S, Frohlich F. Arousal dependent modulation of thalamo-cortical functional interaction. Nat Commun. 2018 Jun 25;9(1):2455. doi: 10.1038/s41467-018-04785-6.
Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Flavio Frohlich principal investigator

Carolina Center for Neurostimulation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Single-pulse TMS in people with Glucose Metabolism Disorders, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Motor Evoked Potential (MEP) (time frame: Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04031404, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021; AzTrials last refreshed its copy on 26 Oct 2026.