Adverse Effects of Systemic Hypoglycemia Exposure on Endothelial Function in Humans
NCT01660009 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2017-08-14
Summary
Prior work suggests exposure to low glucose levels (hypoglycemia) is associated with increased cardiovascular risk. However, whether there is a causal relationship between cardiovascular events and hypoglycemia remains unclear with conflicting data in the literature. In this study, we plan to study whether acute exposure of patients to clinically relevant (50-60 milligrams/deciliter) levels of hypoglycemia induces or worsens blood vessel endothelial dysfunction- a key 1st step in the development of heart attacks and strokes. This will be determined in humans both with and with type 2 diabetes.
Conditions
Interventions
- OTHER
-
Glycemic clamping
During hypoglycemic clamping, individuals will have a blood glucose level of 50-60 mg/dL for approximately 1 hour prior to outcome measurements. During euglycemic clamping, individuals will have a blood glucose level of 85-99 mg/dL for approximately 1 hour prior to outcome measurements.
Sponsors & Collaborators
-
Medical College of Wisconsin
lead OTHER
Principal Investigators
-
Michael E Widlansky, MD, MPH · Medical College of Wisconsin
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-06-30
- Primary Completion
- 2017-06-30
- Completion
- 2017-06-30
Countries
- United States
Study Locations
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