MedPath

GLP-1 and Hypoglycemia

Early Phase 1
Active, not recruiting
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Glucagon-Like Peptide- 1 (GLP-1) infusion
Registration Number
NCT01858896
Lead Sponsor
University of Maryland, Baltimore
Brief Summary

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

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
28
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Glucagon-Like Peptide -1 (GLP-1) infusionGlucagon-Like Peptide- 1 (GLP-1) infusionInfusion of GLP-1 during experimental period
Primary Outcome Measures
NameTimeMethod
Change in Plasminogen Activation inhibitor-1 (PAi-1)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 in Flow mediated dilation (FMD)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)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Maryland, Baltimore

🇺🇸

Baltimore, Maryland, United States

© Copyright 2025. All Rights Reserved by MedPath