Recruiting
Early Phase 1

Observational Study

Sponsor:

University of Maryland, Baltimore

Code:

NCT02445781

Conditions

Hypoglycemia

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Glucose clamp

Study Details

Brief summary:

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

Hypoglycemia

Study ID

NCT02445781

Start date

Jul, 2015

Status verified date

Nov, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 90 mg/dl glucose clamp

Glucose clamp intervention of 90 mg/dl maintained for 90 minutes.

experimental: 70 mg/dl glucose clamp

Glucose clamp intervention of 70 mg/dl maintained for 90 minutes.

experimental: 60 mg/dl glucose clamp

Glucose clamp intervention of 60 mg/dl maintained for 90 minutes.

experimental: 50 mg/dl glucose clamp

Glucose clamp intervention of 50 mg/dl maintained for 90 minutes.

Interventions

Glucose clamp

Different levels of hypoglycemia

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Maka Siamashvili, MD

410-706-5623msiamashvili@som.umaryland.edu

Locations

University of Maryland, Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Maka Siamashvili, MD

410-706-5623

Principal Investigator:

Stephen N Davis, MBBS

University of Maryland, Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Maka Siamashvili, MD

410-706-5623

Maka Hedrington, MD

410-706-5623msiamashvili@som.umaryland.edu

Principal Investigator:

Stephen N Davis, MBBS

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2025-11-10.