Glucagon-like Peptide-1 in Type 1 Diabetes

Type1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04355832
• Other study ID #: HP-00090856
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 24, 2020
• Est. completion date: July 2026

Study information

• Verified date: September 2023
• Source: University of Maryland, Baltimore
• Contact: Maka Siamashvili, MD
• Phone: 410-706-5623
• Email: msiamashvili[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type1 Diabetes Mellitus

Intervention

Drug:
• Glucagon-like peptide-1
Infusion of Glucagon-like peptide-1
• Placebos
Infusion of normal saline solution that will mimic Glucagon-like peptide-1

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the level of catecholamines in plasma		3 years