Differing Levels of Hypoglycemia

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · May 14, 2015

Keywords

ClinConnect Summary

This clinical trial is studying how different levels of low blood sugar (hypoglycemia) affect blood vessels and the body's response to inflammation in healthy individuals. Researchers want to understand how these varying levels of low blood sugar impact the body, which could help improve treatments for people who experience hypoglycemia.

To join the study, participants need to be between 65 and 74 years old and have a body mass index (BMI) greater than 21. However, some people may not be eligible, such as those who are pregnant, currently smoking, or have certain health conditions like severe heart disease or uncontrolled high blood pressure. If you decide to take part, you can expect to undergo some tests and evaluations to ensure your safety throughout the study. It's important to know that the study is currently looking for participants, and your involvement could contribute to valuable insights for understanding low blood sugar effects.

Gender

ALL

Eligibility 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)