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OpenTrials
Active, Not Recruiting

NCT Number: NCT01858896

GLP-1 and Hypoglycemia

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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

Drug

GLP-1 infusion during experimental period

Other names: GLP-1

Placebo Comparator: Saline Infusion

Other

Saline infusion (placebo) during experimental period

Other names: Saline infusion

Primary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

Hypoglycemia Associated Autonomic Dysfunction

Important dates

Study start
2013
Primary completion
2026
Study completion
2026
First posted
May 21, 2013
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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