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Glucagon-like Peptide-1 in Type 1 Diabetes

NCT ID: NCT04355832

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-24

Study Completion Date

2025-09-24

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type1 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo 1

The participants will be randomized to placebo infusion.

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Infusion of normal saline solution that will mimic Glucagon-like peptide-1

Placebo 2

The participants will be randomized to placebo infusion.

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Infusion of normal saline solution that will mimic Glucagon-like peptide-1

GLP-1

The participants will be randomized to Glucagon-like peptide-1 infusion.

Group Type EXPERIMENTAL

Glucagon-like peptide-1

Intervention Type DRUG

Infusion of Glucagon-like peptide-1

Interventions

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Glucagon-like peptide-1

Infusion of Glucagon-like peptide-1

Intervention Type DRUG

Placebos

Infusion of normal saline solution that will mimic Glucagon-like peptide-1

Intervention Type DRUG

Eligibility Criteria

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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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Stephen N. Davis, MBBS

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Maryland

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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HP-00090856

Identifier Type: -

Identifier Source: org_study_id