Improving awareness of low blood sugar in diabetes with metoclopramide
Official title: Restoration of Hypoglycemia Awareness With Metoclopramide
Run by University of Kentucky · NCT03970720 · Data updated 2026-11-12
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 | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | University of Kentucky Academic / other |
| Locations | 2 sites (Lexington, Kentucky and 1 other locations) |
| Status | Recruiting |
| Started | May 28, 2019 |
| Main results expected | June 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | March 20, 2026 |
| Trial ID | NCT03970720 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with a history of serious cardiac issues, stroke, or other significant health conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Effect of Dichloroacetate on Brain Function in Type 1 Diabetes During Hypoglycemia
This study is testing if a drug called dichloroacetate can help people with Type 1 Diabetes think better during low blood sugar episodes by improving how their brains use glucose.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.