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Restoration of Hypoglycemia Awareness With Metoclopramide

ConditionHypoglycemia Unawareness
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-60
SponsorSimon Fisher

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Metoclopramide

    Drug

    10 mg metoclopramide four times a day

  • Placebo

    Drug

    10 mg matching placebo capsules four times a day

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: T1DM - Unaware: MetoclopramideExperimental treatment 1 intervention
Group B: T1DM - Unaware: PlaceboPlacebo comparator 1 intervention
Group C: T1DM - Aware: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Blood Glucagon

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.

Time frame
4 weeks
2

Change in Blood Epinephrine

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.

Time frame
4 weeks
3

Change in Blood Norepinephrine

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.

Time frame
4 weeks
4

Change in Blood Cortisol

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.

Time frame
4 weeks

Secondary outcomes

1

Ratio of Self-Reported Hypoglycemic Episodes to Total Hypoglycemic Episodes

Participants will complete a report of all hypoglycemic events during the study surveillance periods. The average ratio of self-reported hypoglycemic episodes to total hypoglycemic episodes recorded by Continuous Glucose Monitoring (CGM) during these periods will be compared between the study arms.

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Simon Fisher

Lead sponsor

University of Kentucky

Sponsor institution

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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