Glucagon-like Peptide-1 in Type 1 Diabetes

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Apr 17, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating a medication called GLP-1 to see if it can help protect the blood vessels in people with type 1 diabetes, especially during episodes of low blood sugar. Researchers believe that GLP-1 may reduce certain harmful effects that can occur when someone experiences repeated low blood sugar levels. This study is currently looking for participants aged 18 to 50 years who have type 1 diabetes, have a specific level of blood sugar control (HbA1c less than 11.0%), and do not have significant diabetes-related complications.

If you choose to participate, you will undergo some initial screenings to ensure you meet the eligibility criteria, and you will be asked to give your informed consent, meaning you understand the trial and agree to take part. Throughout the study, you may have to visit the clinic for assessments and treatments, and you'll be closely monitored for your health and safety. It's important to note that certain medications and health conditions may exclude you from participating, so discussing your medical history with the research team will be key.

Gender

ALL

Eligibility 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