Glucagon-like Peptide-1 in Type 1 Diabetes

  • STATUS
    Recruiting
  • End date
    Jul 27, 2024
  • participants needed
    40
  • sponsor
    University of Maryland, Baltimore
Updated on 27 April 2022

Summary

The hypotheses to be tested in this application is: GLP-1 will acutely protect arterial endothelial function and reduce pro-atherothrombotic and pro-coagulant effects of repeated hypoglycemia in T1DM.

Description

The naturally occurring hormone GLP-1 when co-administered during hypoglycemia (low blood sugar) in non-diabetic individuals can reduce the deleterious effects of hypoglycemia on the vasculature. We have shown that IV infusion of GLP-1 during a single moderate episode of hypoglycemia can preserve endothelial function and protect the vasculature from pro-coagulant and pro-inflammatory effects in healthy individuals.

It is unknown whether GLP-1 could protect the vasculature during episodes of repeated hypoglycemia and whether GLP-1 would have protective effects in T1DM individuals.

Details
Condition Type1 Diabetes Mellitus
Treatment placebos, Glucagon-like Peptide-1
Clinical Study IdentifierNCT04355832
SponsorUniversity of Maryland, Baltimore
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

(20 males, 20 females) individuals with type 1 diabetes aged 18-50 yr
HbA1c < 11.0%
Body mass index < 40kg • m-2
No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)

Exclusion Criteria

Subjects unable to give voluntary informed consent
Pregnancy
Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
Subjects taking any of the following medications will be excluded: non-selective beta blockers
sedative-hypnotics, anticonvulsants, antiparkinsonian drugs, antipsychotics, antidepressants
mood stabilizers, CNS stimulants, opioids, hallucinogens
Subjects unwillingness or inability to comply with approved contraception measures
Subjects with a history of severe uncontrolled hypertension (i.e., blood pressure greater than 160/100), heart disease, cerebrovascular incidents
Clinically significant cardiac abnormalities (e.g. heart failure, arrhythmias, ischemic tachycardia, S-T segment deviations, etc.) from history or from cardiac stress testing in subjects ≥ 40 years old
Pneumonia
Hepatic failure /jaundice
Abnormal results following screening tests and physical examination that are clinically significant
Acute cerebrovascular/ neurological deficit
Fever greater than 38.0 C
Screening Laboratory Tests Exclusion Criteria
Hematocrit lower than 32
WBC lower than 3 thou/ul or greater than 14 thou/ul
Liver function tests: SGOT and SGPT greater than twice upper limit of normal range (i.e. > 80 U/L)
TBil > 2 mg/dl
Creatinine > 1.6 mg/dl
Alkaline phosphatase > 150U/L
Hepatic transaminase > 2x normal
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