GLP-1 and Hypoglycemia

March 5, 2024 updated by: Stephen N. Davis, MBBS, University of Maryland, Baltimore

Hypoglycemia Associated Autonomic Dysfunction

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glucagon-Like Peptide -1 (GLP-1) infusion
Infusion of GLP-1 during experimental period
Drug: Glucagon-Like Peptide- 1 (GLP-1) infusion
GLP-1 infusion during experimental period
Other Names:
  • GLP-1
Placebo Comparator: Saline Infusion
Saline infusion during experimental period
Other: Placebo Comparator: Saline Infusion
Saline infusion (placebo) during experimental period
Other Names:
  • Saline infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Plasminogen Activation inhibitor-1 (PAi-1)
Time Frame: change from baseline to end of clamp period
measurements of change in PAi-1 at baseline and during the end of the glucose clamp period (2 hours)
change from baseline to end of clamp period
Change in Flow mediated dilation (FMD)
Time Frame: change from baseline and end of clamp
flow mediated dilation of the brachial artery will be measured for change from baseline and end of glucose clamp (~4 hours)
change from baseline and end of clamp

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Investigators

  • Principal Investigator: Stephen N Davis, MBBS, 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 Major Dates

Study Start

July 1, 2013

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

May 16, 2013

First Posted (Estimated)

May 21, 2013

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP00055308

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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