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 range

18 Years – 50 Years

Sex

ALL

See this in plain English?

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in the level of catecholamines in plasma

Timeframe: 3 years

Trial details

NCT IDNCT04355832

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-24

View on ClinicalTrials.gov More Type1 Diabetes Mellitus trials

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.