Restoration of Hypoglycemia Awareness With Metoclopramide
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 Start (Actual) 28 May 2019
🗓️ Primary Completion (Estimated) 31 March 2026
✅ Study Completion (Estimated) 31 March 2026
👥 Enrollment (Estimated) 36
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Lexington, Kentucky, United States
📍 Salt Lake City, Utah, United States

📋 Eligibility Criteria

Description

    Inclusion 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

    Exclusion Criteria:

    • * 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 (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 29 May 2019
  • First Submitted that Met QC Criteria 29 May 2019
  • First Posted 31 May 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 April 2024
  • Last Update Posted 2 May 2024
  • Last Verified April 2024