Glucagon-like Peptide-1 in Type 1 Diabetes (NCT04355832) | Clinical Trial Compass
WithdrawnEarly Phase 1
Glucagon-like Peptide-1 in Type 1 Diabetes
Stopped: We were unable to obtain GLP-1
United States0Started 2020-06-24
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …