Restoration of Hypoglycemia Awareness With Metoclopramide

Launched by SIMON FISHER · May 29, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a medication called metoclopramide to see if it can help people with type 1 diabetes who have lost their ability to feel when their blood sugar is low (a condition known as hypoglycemia unawareness). The goal is to determine if this drug can improve their awareness of low blood sugar symptoms and reduce the frequency of hypoglycemic episodes. The trial is currently looking for participants who have had type 1 diabetes for more than five years and have a specific measure of blood sugar control (called hemoglobin A1c) at or below 9%.

To be eligible for this trial, participants must be able to give their consent and should not have certain medical conditions like heart disease, stroke, or severe liver problems. If you or someone you know is interested, participants can expect to receive metoclopramide and will be monitored throughout the study. It's important to note that this trial excludes those who have recently participated in similar studies or are currently using specific types of glucose monitoring systems. This study could provide valuable insights into improving awareness of low blood sugar symptoms in people with diabetes.

Gender

ALL

Eligibility criteria

• 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