Principal Investigator: Simon Fisher
Keywords: Type 1 Diabetes , hypoglycemia awareness , metoclopramide , study drug , clinical trial , clamp study , control group , hypoglycemia unawareness Department: Internal Medicine Admin
IRB Number: 00118549 Co Investigator: Owen Chan
Specialty: Endocrinology and Metabolism, Endocrinology and Metabolism, Endocrinology and Metabolism
Sub Specialties: Diabetes, Type 1 Diabetes and Intensive Insulin Therapy
Recruitment Status: Recruiting

Contact Information

Simon Fisher
sfisher@u2m2.utah.edu
(801)585-6401

Brief Summary

To evaluate whether metoclopramide improves the hypoglycemia counterregulatory hormones and hypoglycemia awareness, and decreases the incidence of hypoglycemia in type 1 diabetes patients with hypoglycemia unawareness.

Inclusion Criteria

  1. Subjects with Type 1 Diabetes
  2. Age 20-60 years
  3. Diabetes duration > 5 years
  4. Hemoglobin A1c ≤ 9%
  5. Able to provide informed consent and willing to sign an approved consent form that conforms to   federal and institutional guidelines

Exclusion Criteria

  1. History of myocardial infarction, cardiac arrhythmia, congestive heart failure and coronary artery insufficiency
  2. History stroke or brain disease
  3. History of genitourinary obstruction/urinary retention
  4. Advanced liver disease
  5. Active anemia with hemoglobin less than 11 g/dL
  6. Female in pregnancy or not able to practice effective contraception during the study period; breastfeeding
  7. Uncontrolled mania or active major depressive disorder
  8. Previous allergic reaction or side effect to heparin use
  9. 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 and opioids, active alcohol/drug abuse, or other sedatives.
  10. Participation in a study/studies evaluating treatment for impaired awareness of hypoglycemia or hypoglycemia-associated autonomic failure in the last 30 days
  11. Frequent need acetaminophen administration