Glucagon-like Peptide-1 in Type 1 Diabetes
Purpose
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.
Condition
- Type1 Diabetes Mellitus
Eligibility
- Eligible Ages
- Between 18 Years and 50 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo 1 |
The participants will be randomized to placebo infusion. |
|
|
Placebo Comparator Placebo 2 |
The participants will be randomized to placebo infusion. |
|
|
Experimental GLP-1 |
The participants will be randomized to Glucagon-like peptide-1 infusion. |
|
Recruiting Locations
Baltimore, Maryland 21201
More Details
- Status
- Recruiting
- Sponsor
- University of Maryland, Baltimore
Detailed 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.