Actively Recruiting
Restoration of Hypoglycemia Awareness With Metoclopramide
Led by Simon Fisher · Updated on 2026-03-20
36
Participants Needed
2
Research Sites
448 weeks
Total Duration
On this page
Sponsors
S
Simon Fisher
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Restoration of Hypoglycemia Awareness With Metoclopramide
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Type 1 Diabetes Mellitus
- Diabetes duration longer than 5 years
- Hemoglobin A1c of 9% or less
- Able and willing to provide informed consent according to federal and institutional guidelines
You will not qualify if you...
- History of myocardial infarction, cardiac arrhythmia, congestive heart failure, or 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 who is pregnant, breastfeeding, or unable to use effective contraception during the study
- Uncontrolled mania or active major depressive disorder
- Previous allergic reaction or side effects to heparin
- Contraindications to metoclopramide or conditions increasing risk with metoclopramide use, including hypersensitivity, mechanical gastrointestinal obstruction, uncontrolled hypertension, pheochromocytoma, seizure disorders, Parkinson's disease, recent use of neuroleptics, antipsychotics, benzodiazepines, monoamine oxidase inhibitors, opioids, active alcohol or drug abuse, or other sedatives
- Participation in another study on hypoglycemia awareness or autonomic failure in the last 30 days
- Current use of unblinded real-time Continuous Glucose Monitoring System
- Frequent need for acetaminophen administration
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of Kentucky
Lexington, Kentucky, United States, 40516
Actively Recruiting
2
University of Utah
Salt Lake City, Utah, United States, 84132
Completed
Research Team
S
Simon Fisher, MD, PhD
CONTACT
K
Karen M Shearer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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