Restoration of Hypoglycemia Awareness With Metoclopramide
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 20 Years to 60 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether metoclopramide can help people notice low blood sugar and have fewer low blood sugar episodes. It is for people with type 1 diabetes who do not notice when their blood sugar is low.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have had type 1 diabetes for more than 5 years.
- Have an A1c of 9% or less. A1c measures average blood sugar over time.
- Can understand and agree to join the study and are willing to sign a consent form.
Who can't join
- Have a history of heart attack, abnormal heart rhythm, heart failure, poor blood flow to the heart, stroke, or brain disease.
- Have a history of a blocked urinary tract or trouble emptying the bladder; have advanced liver disease; or have anemia (low red blood cells) with hemoglobin below 11 g/dL.
- Are pregnant, breastfeeding, or unable to use effective birth control during the study.
- Have uncontrolled mania (an extremely high or irritable mood) or current major depression.
- Have had an allergy or side effect from heparin, or cannot safely take metoclopramide. This includes a metoclopramide allergy, a blocked stomach or bowel, uncontrolled high blood pressure, pheochromocytoma (an adrenal gland tumor), seizures, or Parkinson’s disease.
- Have used neuroleptic or antipsychotic drugs in the past 6 months, benzodiazepines in the past month, or MAO inhibitors or opioids in the past 14 days; use other sedatives; currently misuse alcohol or drugs; or often need acetaminophen.
- Have joined another study in the past 30 days testing treatment for not noticing low blood sugar or for weakened body warning responses to low blood sugar.
- Currently use a continuous glucose monitor that lets you see blood sugar readings in real time.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (2)
KY
- University of Kentucky · Lexington, KY 40516Simon Fisher, MD, PhD · Study contact · 859-562-0473 · Simon.Fisher@uky.eduKaren Shearer, HIT · Study contact · 8593237778 · Karen.Shearer@uky.eduSimon Fisher, MD, PhD · Principal investigatorMore trials in Lexington
UT
- University of Utah · Salt Lake City, UT 84132More trials in Salt Lake City