RECRUITING

Restoration of Hypoglycemia Awareness With Metoclopramide

Conditions

Hypoglycemia Unawareness Type 1 Diabetes Mellitus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Metoclopramide is a drug approved by the FDA for gastroesophageal reflux and to relieve symptoms in adults with acute and recurrent diabetic gastroparesis. The objective of this study is to determine whether metoclopramide can improve hypoglycemia awareness and decrease the incidence of hypoglycemia in type 1 diabetes patients with hypoglycemia unawareness.

Official Title

Restoration of Hypoglycemia Awareness With Metoclopramide

Quick Facts

Study Start:2019-05-28

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03970720

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Subjects with Type 1 Diabetes Mellitus * Diabetes duration \> 5 years * Hemoglobin A1c ≤ 9% * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines	* History of myocardial infarction, cardiac arrhythmia, congestive heart failure and coronary artery insufficiency * History of stroke or brain disease * History of genitourinary obstruction or urinary retention * Advanced liver disease * Active anemia with hemoglobin less than 11 g/dL * Female in pregnancy or breastfeeding, or not able to practice effective contraception during the study period * Uncontrolled mania or active major depressive disorder * Previous allergic reaction or side effect to heparin use * Contraindications to metoclopramide or conditions raising the risk for complication development to metoclopramide, such as hypersensitivity to metoclopramide, ongoing mechanical gastrointestinal obstruction, uncontrolled hypertension, pheochromocytoma, seizure disorders, Parkinson's disease, use of neuroleptics or antipsychotics within 6 months, use of benzodiazepines within the last month, active or recent (last 14 days) use of monoamine oxidase inhibitors or opioids, active alcohol or drug abuse, or other sedatives * Participation in another study evaluating treatment for impaired awareness of hypoglycemia or hypoglycemia-associated autonomic failure in the last 30 days * Current use of unblinded real-time Continuous Glucose Monitoring System * Frequent need of acetaminophen administration

Inclusion Criteria

Exclusion Criteria

* Subjects with Type 1 Diabetes Mellitus
* Diabetes duration \> 5 years
* Hemoglobin A1c ≤ 9%
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

* History of myocardial infarction, cardiac arrhythmia, congestive heart failure and coronary artery insufficiency
* History of stroke or brain disease
* History of genitourinary obstruction or urinary retention
* Advanced liver disease
* Active anemia with hemoglobin less than 11 g/dL
* Female in pregnancy or breastfeeding, or not able to practice effective contraception during the study period
* Uncontrolled mania or active major depressive disorder
* Previous allergic reaction or side effect to heparin use
* Contraindications to metoclopramide or conditions raising the risk for complication development to metoclopramide, such as hypersensitivity to metoclopramide, ongoing mechanical gastrointestinal obstruction, uncontrolled hypertension, pheochromocytoma, seizure disorders, Parkinson's disease, use of neuroleptics or antipsychotics within 6 months, use of benzodiazepines within the last month, active or recent (last 14 days) use of monoamine oxidase inhibitors or opioids, active alcohol or drug abuse, or other sedatives
* Participation in another study evaluating treatment for impaired awareness of hypoglycemia or hypoglycemia-associated autonomic failure in the last 30 days
* Current use of unblinded real-time Continuous Glucose Monitoring System
* Frequent need of acetaminophen administration

Contacts and Locations

Study Contact

Simon Fisher, MD, PhD

CONTACT

859-562-0473

sjfi230@uky.edu

Karen M Shearer

CONTACT

859-323-7778

Karen.Shearer@uky.edu

Principal Investigator

Simon Fisher, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Kentucky

Study Locations (Sites)

University of Kentucky

Lexington, Kentucky, 40516

United States

University of Utah

Salt Lake City, Utah, 84132

United States

Collaborators and Investigators

Sponsor: Simon Fisher

Simon Fisher, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-28

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2019-05-28

Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

Type 1 Diabetes Mellitus

Additional Relevant MeSH Terms

Hypoglycemia Unawareness