Restoration of Hypoglycemia Awareness With Metoclopramide

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.

Conditions

Hypoglycemia Unawareness

Study Overview

Study Details

Study overview

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.

Restoration of Hypoglycemia Awareness With Metoclopramide

Restoration of Hypoglycemia Awareness With Metoclopramide

Condition
Hypoglycemia Unawareness
Intervention / Treatment

-

Contacts and Locations

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40516

Salt Lake City

University of Utah, Salt Lake City, Utah, United States, 84132

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

20 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Simon Fisher,

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

Study Record Dates

2026-03-31