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