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Trial · NCT03970720

Restoration of Hypoglycemia Awareness With Metoclopramide

NCT03970720, Phase 2, Recruiting, Simon Fisher

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Restoration of Hypoglycemia Awareness With Metoclopramide. Trials, record NCT03970720. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03970720

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Restoration of Hypoglycemia Awareness With Metoclopramide
NCT number
NCT03970720
Status
Recruiting
Phases
Phase 2
Enrollment
36 participants, estimated
Lead sponsor
Simon Fisher
Conditions
Hypoglycemia Unawareness
Interventions
Metoclopramide, Placebo
First posted
2019-05-31
Last updated
2026-03-20

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Blood Glucagon4 weeks
Blood samples will be drawn from study participants during the initial hypoglycemic clamp study (Day 0) and during the second hypoglycemic clamp study (Day 28) following the 4-week intervention period. The average change in blood glucagon level will be compared between the study arms.
PrimaryChange in Blood Epinephrine4 weeks
Blood samples will be drawn from study participants during the initial hypoglycemic clamp study (Day 0) and during the second hypoglycemic clamp study (Day 28) following the 4-week intervention period. The average change in blood epinephrine level will be compared between the study arms.
PrimaryChange in Blood Norepinephrine4 weeks
Blood samples will be drawn from study participants during the initial hypoglycemic clamp study (Day 0) and during the second hypoglycemic clamp study (Day 28) following the 4-week intervention period. The average change in blood norepinephrine level will be compared between the study arms.
PrimaryChange in Blood Cortisol4 weeks
Blood samples will be drawn from study participants during the initial hypoglycemic clamp study (Day 0) and during the second hypoglycemic clamp study (Day 28) following the 4-week intervention period. The average change in blood cortisol level will be compared between the study arms.
PrimaryChange in Blood Pancreatic Polypeptide4 weeks
Blood samples will be drawn from study participants during the initial hypoglycemic clamp study (Day 0) and during the second hypoglycemic clamp study (Day 28) following the 4-week intervention period. The average change in blood pancreatic polypeptide level will be compared between the study arms.
PrimaryChange in Hypoglycemia Symptom Recognition4 weeks
Participant's self-reported symptoms of hypoglycemia will be obtained during the initial hypoglycemic clamp study (Day 0) and during the second hypoglycemic clamp study (Day 28) following the 4-week intervention period.
SecondaryRatio of Self-Reported Hypoglycemic Episodes to Total Hypoglycemic Episodes6 weeks
Participants will complete a report of all hypoglycemic events during the study surveillance periods. The average ratio of self-reported hypoglycemic episodes to total hypoglycemic episodes recorded by Continuous Glucose Monitoring (CGM) during these periods will be compared between the study arms.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers9

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
1991573BACKGROUNDPubMed
8243825BACKGROUNDPubMed
15089796BACKGROUNDPubMed
15343587BACKGROUNDPubMed
18290864BACKGROUNDPubMed
18387080BACKGROUNDPubMed
22314041BACKGROUNDPubMed
23883381BACKGROUNDPubMed
24095133BACKGROUNDPubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
R01DK118082Pharmacological Approach to the Restoration of Hypoglycemia AwarenessFISHER, SIMON JUNIVERSITY OF KENTUCKYNATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES2019 to 2023

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03970720

GET https://conductscience.org/api/trials/v1/NCT03970720/registered