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RecruitingAccepts healthy volunteersEarly Phase 1

Differing Levels of Hypoglycemia

University of Maryland, Baltimore · with Vanderbilt University · NCT02445781

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–55 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Early Phase 1
Target enrollment
32
US sites recruiting
2
Study start
July 2015
Record last updated
November 10, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the 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. 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.

Being studied: Glucose clamp

Conditions: Hypoglycemia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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)

Recruiting US locations

  • University of Maryland, Baltimore

    Baltimore, MD 21201

    Site contact: Maka Siamashvili, MD · 410-706-5623

  • University of Maryland, Baltimore

    Baltimore, MD 21201

    Site contact: Maka Siamashvili, MD · 410-706-5623

Study contacts (from the official record)

  • Maka Siamashvili, MD · 410-706-5623 · msiamashvili@som.umaryland.edu
All healthy volunteers studies in Maryland →
Differing Levels of Hypoglycemia (NCT02445781) | Bored Studies