Study on Differing Levels of Hypoglycemia

This study is looking into how different levels of hypoglycemia (low blood sugar) affect your blood vessels and how your blood clots. Researchers want to understand why low blood sugar might lead to heart problems or even death, especially in people with diabetes. You might be able to join if you are between 18 and 55 years old, have a body mass index (BMI) over 21, and are not pregnant or on certain medications like blood thinners. The study will use a glucose clamp (a device to control blood sugar levels) to create different levels of low blood sugar. Success will be measured by looking at changes in your brachial artery (a major artery in your arm) before and after the low blood sugar event. The current status of this study is unclear, and it plans to enroll 32 participants.

Study design
This interventional study plans to enroll 32 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo measurements of your brachial artery at 120 minutes before and 240 minutes after a glucose clamp procedure. The total duration of participation is not specified.
Compensation
Not stated in the trial record.
Follow-up
Measurements are taken up to 240 minutes (4 hours) after the glucose clamp procedure. Longer-term follow-up is not specified.

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NCT02445781

Differing Levels of Hypoglycemia

Recruiting
EARLY_PHASE1Ages 18–55InterventionalTreatment
University of Maryland, Baltimore
~32 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:Glucose clamp

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Flow mediated vasodilation of brachial artery measurements (mean maximum % change)
Measured over 120 minutes (pre) clamp and 240 minutes (post) clamp
Hypoglycemia
2 sites across 1 states
Maryland2

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Eligibility criteria

Exclusion

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
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
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)
  • Flow mediated vasodilation of brachial artery measurements (mean maximum % change)120 minutes (pre) clamp and 240 minutes (post) clamp

    baseline (pre) measurements compared to end of clamp (post) measurements