RECRUITING

Glucagon-like Peptide-1 in Type 1 Diabetes

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-06-24

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04355832

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

Maka Siamashvili, MD

CONTACT

410-706-5623

msiamashvili@som.umaryland.edu

Stephen N Davis, MBBS

CONTACT

Study Locations (Sites)

University of Maryland

Baltimore, Maryland, 21201

United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-06-24

Study Completion Date2026-09

Study Record Updates

Study Start Date2020-06-24

Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

Type1 Diabetes Mellitus