Effects of different levels of low blood sugar on blood vessels

Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Differing Levels of Hypoglycemia

This study tests how different levels of low blood sugar affect blood vessels in healthy people to better understand the risks linked to hypoglycemia, especially for those with diabetes.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: University of Maryland, Baltimore (Academic / other)
• Locations: 2 sites (Baltimore, Maryland and 1 other locations)
• Trial ID: NCT02445781 on ClinicalTrials.gov

What this trial studies

This study investigates how varying levels of hypoglycemia affect vascular biological mechanisms in healthy individuals. It aims to understand the pro-inflammatory and pro-atherothrombotic changes that occur during hypoglycemia, which have not been thoroughly explored in previous research. The methodology involves using a glucose clamp technique to precisely control blood sugar levels and observe the resulting biological responses. The findings could provide insights into the risks associated with hypoglycemia, particularly in populations with diabetes.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults with a body mass index greater than 21 kg/m².

Not a fit: Patients with severe uncontrolled hypertension, significant heart disease, or those currently using anticoagulant drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for preventing hypoglycemia-related complications in patients with diabetes.

How similar studies have performed: While there have been numerous studies on glucose control in diabetes, this specific investigation into the vascular effects of hypoglycemia is relatively novel and has not been extensively tested.

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)

Where this trial is running

Baltimore, Maryland and 1 other locations

• University of Maryland, Baltimore — Baltimore, Maryland, United States (Recruiting)
• University of Maryland, Baltimore — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: Maka Siamashvili, MD

Conditions Hypoglycemia