RECRUITING

Differing Levels of Hypoglycemia

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Hypoglycemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Differing Levels of Hypoglycemia

Quick Facts

Study Start:2015-07
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02445781

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Pregnant women
  2. * Subjects unwilling or unable to comply with approved contraception measures
  3. * Subjects unable to give voluntary informed consent
  4. * Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
  5. * Subjects with a history of severe, uncontrolled hypertension, heart disease, cerebrovascular incidents
  6. * Current tobacco use
  7. * Subjects with any known allergies to any of the study medications being used
  8. * Uncontrolled severe hypertension (i.e., blood pressure greater than 160/100)
  9. * Clinically significant cardiac abnormalities (e.g. heart failure, arrhythmia)
  10. * Pneumonia treatment or hospitalization within 2 weeks prior to enrollment (study visit)
  11. * Hepatic failure / jaundice
  12. * Renal failure
  13. * Cerebrovascular accident occurrence or hospitalization within 4 weeks prior to enrollment
  14. * Fever greater than 38.0 degrees C
  15. * Hematocrit lower than 32 %
  16. * White blood cell (WBC) count lower than 3 thou/ul or greater than 14 thou/ul
  17. * Liver function tests: serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT) greater than twice upper limit of normal range
  18. * Alkaline phosphatase greater than 150U/L
  19. * Total bilirubin (TBil) greater than 2 mg/dl
  20. * Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2
  21. * Positive human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
  22. * Any abnormal cardiac response during multi-stage exercise test (if over 40 years of age)

Contacts and Locations

Study Contact

Maka Siamashvili, MD
CONTACT
410-706-5623
msiamashvili@som.umaryland.edu

Study Locations (Sites)

University of Maryland, Baltimore
Baltimore, Maryland, 21201
United States
University of Maryland, Baltimore
Baltimore, Maryland, 21201
United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-07
Study Completion Date2026-12

Study Record Updates

Study Start Date2015-07
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Hypoglycemia