Actively Recruiting

Early Phase 1
Age: 18Years - 55Years
All Genders
Healthy Volunteers
NCT02445781

Differing Levels of Hypoglycemia

Led by University of Maryland, Baltimore · Updated on 2025-11-10

32

Participants Needed

2

Research Sites

595 weeks

Total Duration

On this page

Sponsors

U

University of Maryland, Baltimore

Lead Sponsor

V

Vanderbilt University

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Differing Levels of Hypoglycemia

Who Can Participate

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Body mass index >21 kg/m2
Not Eligible

You will not qualify if you...

  • 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 (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
  • Hepatic failure or jaundice
  • Renal failure
  • Cerebrovascular accident or hospitalization within 4 weeks prior to enrollment
  • Fever greater than 38.0 degrees C
  • Hematocrit lower than 32 %
  • White blood cell count lower than 3 thou/ul or greater than 14 thou/ul
  • Liver function tests (SGOT and SGPT) greater than twice upper limit of normal
  • Alkaline phosphatase greater than 150 U/L
  • Total bilirubin greater than 2 mg/dl
  • Estimated glomerular filtration rate less than 60 mL/min/1.73 m2
  • Positive HIV, Hepatitis B or Hepatitis C
  • Any abnormal cardiac response during multi-stage exercise test (if over 40 years of age)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

University of Maryland, Baltimore

Baltimore, Maryland, United States, 21201

Actively Recruiting

2

University of Maryland, Baltimore

Baltimore, Maryland, United States, 21201

Actively Recruiting

Loading map...

Research Team

M

Maka Siamashvili, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here