GLP-1 and Hypoglycemia

NCT ID: NCT01858896

Last Updated: 2025-10-06

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

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2026-12-31

Brief Summary

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Low blood sugar can negatively affect how blood vessels function, and this can lead to an increase in the risk for heart attacks, strokes and other problems related to the stiffening and blockage of blood vessels. The purpose of this study is to learn if and how glucagon-like peptide-1 (GLP-1; a naturally occurring hormone in the gut) changes the effects that low blood sugar levels have on blood vessels.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Glucagon-Like Peptide -1 (GLP-1) infusion

Infusion of GLP-1 during experimental period

Group Type ACTIVE_COMPARATOR

Glucagon-Like Peptide- 1 (GLP-1) infusion

Intervention Type DRUG

GLP-1 infusion during experimental period

Saline Infusion

Saline infusion during experimental period

Group Type PLACEBO_COMPARATOR

Placebo Comparator: Saline Infusion

Intervention Type OTHER

Saline infusion (placebo) during experimental period

Interventions

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Glucagon-Like Peptide- 1 (GLP-1) infusion

GLP-1 infusion during experimental period

Intervention Type DRUG

Placebo Comparator: Saline Infusion

Saline infusion (placebo) during experimental period

Intervention Type OTHER

Other Intervention Names

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GLP-1 Saline infusion

Eligibility Criteria

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Inclusion Criteria

* 14 (7 males, 7 females) healthy controls age 30-60 yr.
* 14 (7 males, 7 females) people with type 2 DM age 30-60 yr.
* For type 2 DM: HbA1c 6-10.0%
* No significant diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc.)
* Body mass index \>25kg • m-2

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Stephen N. Davis, MBBS

Chairman of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen N Davis, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

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University of Maryland, Baltimore

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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HP00055308

Identifier Type: -

Identifier Source: org_study_id

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