NCT03970720 · Simon Fisher
Restoration of Hypoglycemia Awareness With Metoclopramide
What this study 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.
View original scientific description
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.
Interventions
DRUG
Metoclopramide
10 mg metoclopramide four times a day
DRUG
Placebo
10 mg matching placebo capsules four times a day
Primary outcome measures
Change in Blood Glucagon
Time frame: 4 weeks
Blood samples will be drawn from study participants during the initial hypoglycemic clamp study (Day 0) and during the second hypoglycemic clamp study (Day 28) following the 4-week intervention period. The average change in blood glucagon level will be compared between the study arms.
Change in Blood Epinephrine
Time frame: 4 weeks
Blood samples will be drawn from study participants during the initial hypoglycemic clamp study (Day 0) and during the second hypoglycemic clamp study (Day 28) following the 4-week intervention period. The average change in blood epinephrine level will be compared between the study arms.
Change in Blood Norepinephrine
Time frame: 4 weeks
Blood samples will be drawn from study participants during the initial hypoglycemic clamp study (Day 0) and during the second hypoglycemic clamp study (Day 28) following the 4-week intervention period. The average change in blood norepinephrine level will be compared between the study arms.
Change in Blood Cortisol
Time frame: 4 weeks
Blood samples will be drawn from study participants during the initial hypoglycemic clamp study (Day 0) and during the second hypoglycemic clamp study (Day 28) following the 4-week intervention period. The average change in blood cortisol level will be compared between the study arms.
Change in Blood Pancreatic Polypeptide
Time frame: 4 weeks
Blood samples will be drawn from study participants during the initial hypoglycemic clamp study (Day 0) and during the second hypoglycemic clamp study (Day 28) following the 4-week intervention period. The average change in blood pancreatic polypeptide level will be compared between the study arms.
Change in Hypoglycemia Symptom Recognition
Time frame: 4 weeks
Participant's self-reported symptoms of hypoglycemia will be obtained during the initial hypoglycemic clamp study (Day 0) and during the second hypoglycemic clamp study (Day 28) following the 4-week intervention period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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, unco
Where
- Lexington, Kentucky
- Salt Lake City, Utah
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 20, 2026 · Source of record for eligibility and locations