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Device

Glucose Clamp Study for Low Blood Sugar

Phase < 1
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Subjects with a history of severe, uncontrolled hypertension, heart disease, cerebrovascular incidents
Uncontrolled severe hypertension (i.e., blood pressure greater than 160/100)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 minutes (pre) clamp and 240 minutes (post) clamp
Awards & highlights
No Placebo-Only Group

Summary

This trial will investigate the effects of hypoglycemia on the vasculature in healthy people, to see if low blood sugar levels produce pro-inflammatory or pro-atherothrombotic changes.

Who is the study for?
This trial is for healthy individuals with a body mass index over 21 kg/m2. It's not suitable for smokers, those with significant heart issues, allergies to study meds, on blood thinners or anticoagulants, uncontrolled high blood pressure, recent fever or pneumonia, poor kidney/liver function, low/high WBC count, anemia or bleeding disorders.
What is being tested?
The study tests how different levels of low blood sugar affect the body's vascular system in healthy people using a glucose clamp technique. The aim is to understand the biological impact of varying hypoglycemia intensities on vessels and clotting processes.
What are the potential side effects?
While specific side effects are not listed for this procedure-focused trial (glucose clamp), potential risks may include discomfort at the infusion site and symptoms related to induced hypoglycemia such as dizziness, sweating, shakiness and confusion.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of severe heart or blood pressure problems.
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My blood pressure is not higher than 160/100.
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I have kidney failure.
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I am unable to understand and give consent for my treatment.
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I do not have serious heart problems.
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I am over 40 and had an abnormal heart response during an exercise test.
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I am unwilling or unable to follow the required birth control measures.
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I am on blood thinners, have anemia, or a bleeding disorder.
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I have had a fever over 38.0 degrees C.
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I do not have liver failure or jaundice.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 minutes (pre) clamp and 240 minutes (post) clamp
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes (pre) clamp and 240 minutes (post) clamp for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Flow mediated vasodilation of brachial artery measurements (mean maximum % change)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: 90 mg/dl glucose clampExperimental Treatment1 Intervention
Glucose clamp intervention of 90 mg/dl maintained for 90 minutes.
Group II: 70 mg/dl glucose clampExperimental Treatment1 Intervention
Glucose clamp intervention of 70 mg/dl maintained for 90 minutes.
Group III: 60 mg/dl glucose clampExperimental Treatment1 Intervention
Glucose clamp intervention of 60 mg/dl maintained for 90 minutes.
Group IV: 50 mg/dl glucose clampExperimental Treatment1 Intervention
Glucose clamp intervention of 50 mg/dl maintained for 90 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glucose clamp
2010
N/A
~30

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
379,460 Total Patients Enrolled
Vanderbilt UniversityOTHER
710 Previous Clinical Trials
6,143,348 Total Patients Enrolled

Media Library

Glucose clamp (Device) Clinical Trial Eligibility Overview. Trial Name: NCT02445781 — Phase < 1
Low Blood Sugar Research Study Groups: 60 mg/dl glucose clamp, 90 mg/dl glucose clamp, 50 mg/dl glucose clamp, 70 mg/dl glucose clamp
Low Blood Sugar Clinical Trial 2023: Glucose clamp Highlights & Side Effects. Trial Name: NCT02445781 — Phase < 1
Glucose clamp (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02445781 — Phase < 1
~2 spots leftby Sep 2025
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