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
• Status: Active, not recruiting
• Phase: Early Phase 1
• 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
• 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:

-

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypoglycemia
• Type 2 Diabetes Mellitus

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