Overview

Glucagon-like Peptide-1 in Type 1 Diabetes

Status:
Recruiting
Trial end date:
2023-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Maryland, Baltimore
Treatments:
Glucagon
Glucagon-Like Peptide 1
Criteria
Inclusion Criteria:

- 40 (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