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Clinical Trial NCT01858896 for Type 2 Diabetes Mellitus is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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University of Maryland, BaltimoreGLP-1 and Hypoglycemia Early Phase 1 28
Clinical Trial NCT01858896 is designed to study Treatment for Type 2 Diabetes Mellitus. It is a Early Phase 1 interventional study that is active, not recruiting, having started on 1 July 2013, with plans to enroll 28 participants. Led by University of Maryland, Baltimore, it is expected to complete by 1 December 2026. The latest data from ClinicalTrials.gov was last updated on 6 October 2025.
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.
Official Title
Hypoglycemia Associated Autonomic Dysfunction
Conditions
Type 2 Diabetes MellitusOther Study IDs
- HP00055308
NCT ID Number
Start Date (Actual)
2013-07
Last Update Posted
2025-10-06
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
28
Study Type
Interventional
PHASE
Early Phase 1
Status
Active, not recruiting
Keywords
hypoglycemia
GLP-1
Type 2 diabetes
endothelial function
GLP-1
Type 2 diabetes
endothelial function
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorGlucagon-Like Peptide -1 (GLP-1) infusion Infusion of GLP-1 during experimental period | Glucagon-Like Peptide- 1 (GLP-1) infusion GLP-1 infusion during experimental period |
Placebo ComparatorSaline Infusion Saline infusion during experimental period | Placebo Comparator: Saline Infusion Saline infusion (placebo) during experimental period |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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
-
University of Maryland, Baltimore199 active studies to exploreStudy Responsible Party
Stephen N. Davis, MBBS, Principal Investigator, Chairman of Medicine, University of Maryland, Baltimore
No contact data.
1 Study Locations in 1 Countries
Maryland
University of Maryland, Baltimore, Baltimore, Maryland, 21201, United States