Actively Recruiting

Early Phase 1
Age: 18Years - 55Years
All Genders
Healthy Volunteers
ID02445781

Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Differing Levels of Hypoglycemia

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

32

Participants Needed

2

Research Sites

13 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

Researchers are investigating how different levels of low blood sugar (hypoglycemia) affect blood vessel function and blood clotting processes in healthy adults. This study aims to understand the biological effects of mild to moderate hypoglycemia on the vascular system, as previous research has linked severe hypoglycemia to heart problems but has not explained the underlying mechanisms. The research focuses on healthy individuals to provide clear insights into these effects. Participants will undergo a procedure called a glucose clamp, where blood sugar is carefully controlled and maintained at one of four target levels (90, 70, 60, or 50 mg/dl) for 90 minutes. Each participant will be randomly assigned to one of these four groups to compare how different degrees of hypoglycemia influence vascular biology. The glucose clamp is a device-based intervention to keep blood sugar steady during the study period. During the study, researchers will measure blood vessel function using flow-mediated vasodilation of the brachial artery before and after the glucose clamp. Additional evaluations include monitoring inflammation and blood clotting factors related to hypoglycemia. The study includes healthy volunteers aged 18 to 55, with assessments of blood tests and physical health to ensure safety. The total participation involves these measurements to understand the body's response to controlled low blood sugar levels.

CONDITIONS

Brief 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 greater than 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 disorders
  • History of severe, uncontrolled hypertension, heart disease, or stroke
  • Current tobacco use
  • Known allergies to study medications
  • Uncontrolled severe hypertension (blood pressure >160/100)
  • Clinically significant heart abnormalities such as heart failure or arrhythmia
  • Pneumonia treatment or hospitalization within 2 weeks prior to enrollment
  • Liver failure or jaundice
  • Kidney failure
  • Stroke occurrence or hospitalization within 4 weeks prior to enrollment
  • Fever over 38.0 degrees Celsius
  • Hematocrit lower than 32%
  • White blood cell count outside 3 to 14 thousand per microliter
  • Liver enzymes (SGOT, SGPT) more than twice the normal limit
  • Alkaline phosphatase greater than 150 U/L
  • Total bilirubin over 2 mg/dl
  • Estimated glomerular filtration rate less than 60 mL/min/1.73 m²
  • Positive test for HIV, Hepatitis B, or Hepatitis C
  • Abnormal cardiac response during exercise test if over 40 years old

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Each intervention lasts 90 minutes; multiple interventions in a crossover design

Participants receive different levels of hypoglycemia through glucose clamp interventions, each maintained for 90 minutes to assess vascular biological effects.

Multiple visits for each glucose clamp intervention

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

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Research Team

M

Maka Siamashvili, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

4

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