Improving awareness of low blood sugar in diabetes with metoclopramide
Restoration of Hypoglycemia Awareness With Metoclopramide
PHASE2 · University of Kentucky · NCT03970720
This study is testing if the medication metoclopramide can help people with Type 1 Diabetes who can't sense low blood sugar to become more aware of it and reduce their risk of hypoglycemia.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | University of Kentucky (other) |
| Locations | 2 sites (Lexington, Kentucky and 1 other locations) |
| Trial ID | NCT03970720 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of metoclopramide, a medication typically used for gastrointestinal issues, to enhance hypoglycemia awareness in patients with Type 1 Diabetes Mellitus who experience hypoglycemia unawareness. The study aims to determine if metoclopramide can reduce the incidence of hypoglycemia by restoring the body's ability to sense low blood sugar levels. Participants will be randomly assigned to receive either metoclopramide or a placebo, and their responses will be monitored to assess the effectiveness of the treatment. The trial is crucial as it addresses a significant complication in diabetes management that currently lacks effective therapeutic options.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with Type 1 Diabetes Mellitus who have had diabetes for more than 5 years and experience hypoglycemia unawareness.
Not a fit: Patients with a history of serious cardiac issues, stroke, or other significant health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the safety and quality of life for patients with Type 1 Diabetes by restoring their ability to recognize hypoglycemia.
How similar studies have performed: While the approach of using metoclopramide for this purpose is novel, other studies have explored various treatments for hypoglycemia unawareness, but none have established a definitive solution.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lexington, Kentucky and 1 other locations
- University of Kentucky — Lexington, Kentucky, United States (RECRUITING)
- University of Utah — Salt Lake City, Utah, United States (COMPLETED)
Study contacts
- Principal investigator: Simon Fisher, MD, PhD — University of Kentucky
- Study coordinator: Simon Fisher, MD, PhD
- Email: sjfi230@uky.edu
- Phone: 859-562-0473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypoglycemia Unawareness, Type 1 Diabetes Mellitus