NCT02445781 · University of Maryland, Baltimore
Differing Levels of Hypoglycemia
What this study is about
Hypoglycemia can produce a spectrum of pro-inflammatory and pro-atherothrombotic changes. To date no studies appear to have investigated the effects of differing levels of hypoglycemia on the vasculature and pro-atherothrombotic balance during hypoglycemia in healthy man.
View original scientific description
Hypoglycemia can produce a spectrum of pro-inflammatory and pro-atherothrombotic changes. To date no studies appear to have investigated the effects of differing levels of hypoglycemia on the vasculature and pro-atherothrombotic balance during hypoglycemia in healthy man. The specific aim of our study will be to determine the effects of differing levels of hypoglycemia on in-vivo vascular biologic mechanisms in a healthy population.
Interventions
DEVICE
Glucose clamp
Different levels of hypoglycemia
Primary outcome measures
Flow mediated vasodilation of brachial artery measurements (mean maximum % change)
Time frame: 120 minutes (pre) clamp and 240 minutes (post) clamp
baseline (pre) measurements compared to end of clamp (post) measurements
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- • Body mass index \>21kg · m-2
Exclusion criteria
- Pregnant women
- Subjects unwilling or unable to comply with approved contraception measures
- Subjects unable to give voluntary informed consent
- Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
- Subjects with a history of severe, uncontrolled hypertension, heart disease, cerebrovascular incidents
- Current tobacco use
- Subjects with any known allergies to any of the study medications being used Physical Exam Exclusion Criteria
- Uncontrolled severe hypertension (i.e., blood pressure greater than 160/100)
- Clinically significant cardiac abnormalities (e.g. heart failure, arrhythmia)
- Pneumonia treatment or hospitalization within 2 weeks prior to enrollment (study visit)
- Hepatic failure / jaundice
- Renal failure
- Cerebrovascular accident occurrence or hospitalization within 4 weeks prior to enrollment
- Fever greater than 38.0 degrees C Screening Laboratory Tests Exclusion Criteria
- Hematocrit lower than 32 %
- White blood cell (WBC) count lower than 3 thou/ul or greater than 14 thou/ul
- Liver function tests: serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT) greater than twice upper limit of normal range
- Alkaline phosphatase greater than 150U/L
- Total bilirubin (TBil) greater than 2 mg/dl
- Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2
- Positive human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
- Any abnormal cardiac response during multi-stage exercise test (if over 40 years of age)
Where
- Baltimore, Maryland
Collaborators
Vanderbilt University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 10, 2025 · Source of record for eligibility and locations