Reducing Hypoglycemic, Pro-coagulant and Pro-atherothrombotic Responses and Preventing Hypoglycemia Associated Autonomic Failure in Type 1 DM. The Effects of Glucagon-like Peptide-1

Trial ID: NCT04355832

Interventional - Phase 1 - Withdrawn

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.

Conditions

• Type1 Diabetes Mellitus

Interventions

• Glucagon-like peptide-1
• Placebos

Eligibility

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

Sponsor

University of Maryland, Baltimore

Source: ClinicalTrials.gov

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