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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 minutes (pre) clamp and 240 minutes (post) clamp
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 120 minutes (pre) clamp and 240 minutes (post) clamp
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 minutes (pre) clamp and 240 minutes (post) clamp
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Flow mediated vasodilation of brachial artery measurements (mean maximum % change)
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
688 Previous Clinical Trials
374,624 Total Patients Enrolled
Vanderbilt UniversityOTHER
703 Previous Clinical Trials
6,143,315 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently smoke or use tobacco products.I have not been treated for pneumonia or hospitalized for it in the last 2 weeks.Your total bilirubin level is higher than 2 mg/dl.Your hematocrit level is less than 32%.I have a history of severe heart or blood pressure problems.My blood pressure is not higher than 160/100.I have kidney failure.I am unable to understand and give consent for my treatment.I do not have serious heart problems.Your alkaline phosphatase level is higher than 150U/L.Your liver function tests show high levels of SGOT and SGPT.Your white blood cell count is below 3 thousand per microliter or above 14 thousand per microliter.I am over 40 and had an abnormal heart response during an exercise test.You have HIV, Hepatitis B, or Hepatitis C.I am unwilling or unable to follow the required birth control measures.I am on blood thinners, have anemia, or a bleeding disorder.I have had a fever over 38.0 degrees C.Your kidney function is too low, with an estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2.I have not had a stroke or been hospitalized for one in the last 4 weeks.Your body mass index is higher than 21.I do not have liver failure or jaundice.
Research Study Groups:
This trial has the following groups:- Group 1: 60 mg/dl glucose clamp
- Group 2: 90 mg/dl glucose clamp
- Group 3: 50 mg/dl glucose clamp
- Group 4: 70 mg/dl glucose clamp
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the population of this research restricted to individuals beneath forty years old?
"This trial is seeking participants aged between 18 to 55. In addition, there are separate trials for those younger than 18 and older than 65 with 13 enrolment sites and 59 recruitment opportunities respectively."
Answered by AI
Are there any opportunities for individuals to enroll in this research project?
"Affirmative. Clinicaltrials.gov data indicates that recruitment for this research is ongoing, and began on July 1st 2015 with its most recent update occurring April 8th 2022. 32 participants are being recruited from specified medical centres."
Answered by AI
Who is the target population for this research study?
"This medical trial is recruiting 32 individuals between 18 and 55 years old with hypoglycemia. The eligibility criteria includes a minimum body mass index of 21 kg · m-2."
Answered by AI
What is the current enrollment of participants in this clinical experiment?
"Confirmed. According to data hosted on ClinicalTrials.gov, this study is actively recruiting participants since first being posted on July 1st 2015 and last edited April 8th 2022; 32 patients are needed from a single site."
Answered by AI
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