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GLP-1 and Hypoglycemia

Hypoglycemia Associated Autonomic Dysfunction

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01858896
Enrollment
28
Registered
2013-05-21
Start date
2013-07-31
Completion date
2026-12-31
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

hypoglycemia, GLP-1, Type 2 diabetes, endothelial function

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.

Interventions

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

GLP-1 infusion during experimental period

OTHERPlacebo Comparator: Saline Infusion

Saline infusion (placebo) during experimental period

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Change in Plasminogen Activation inhibitor-1 (PAi-1)change from baseline to end of clamp periodmeasurements 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 clampflow mediated dilation of the brachial artery will be measured for change from baseline and end of glucose clamp (\ 4 hours)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026