Using GLP-1 to protect blood vessels during low blood sugar in type 1 diabetes

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

This study is testing if a medication called GLP-1 can help protect blood vessels in people with type 1 diabetes during episodes of low blood sugar.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: University of Maryland, Baltimore (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT04355832 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of glucagon-like peptide-1 (GLP-1) on arterial endothelial function during episodes of repeated hypoglycemia in individuals with type 1 diabetes. The research aims to determine whether GLP-1 can mitigate the harmful vascular effects associated with low blood sugar levels. Participants will receive either GLP-1 or a placebo during controlled hypoglycemic episodes to assess its protective effects on the vasculature. The study focuses on a specific age group and health criteria to ensure participant safety and relevance of results.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 18-50 with type 1 diabetes, an HbA1c level below 11.0%, and no significant diabetic complications.

Not a fit: Patients with severe uncontrolled hypertension, significant cardiac abnormalities, or those on certain medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatments that protect blood vessels in patients with type 1 diabetes during episodes of low blood sugar.

How similar studies have performed: While the protective effects of GLP-1 during hypoglycemia have been observed in non-diabetic individuals, this approach in type 1 diabetes is novel and has not been extensively tested.

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

Where this trial is running

Baltimore, Maryland

• University of Maryland — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: Maka Siamashvili, MD

Conditions Type1 Diabetes Mellitus