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NCT01858896 Clinical Trial

GLP-1 and Hypoglycemia

Type 2 Diabetes Mellitus Clinical Trial

Official title:
Hypoglycemia Associated Autonomic Dysfunction

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01858896
Other study ID # HP00055308
Secondary ID
Status Active, not recruiting
Phase Early Phase 1
First received
Last updated
Start date July 2013
Est. completion date February 2026

Study information
Verified date March 2024
Source University of Maryland, Baltimore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 28
Est. completion date February 2026
Est. primary completion date February 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Glucagon-Like Peptide- 1 (GLP-1) infusion
GLP-1 infusion during experimental period
Other:
• Placebo Comparator: Saline Infusion
Saline infusion (placebo) during experimental period

Locations
Country Name City State
United States University of Maryland, Baltimore Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Plasminogen Activation inhibitor-1 (PAi-1) 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
Primary Change in Flow mediated dilation (FMD) 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
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