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Controlled Blood Sugar Variation for Stress Response (Hypo fMRI Trial)
N/A
Recruiting
Led By Roy Freeman, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males and Females age 18 to 45 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8 hours after physiological stress, and 4 days after physiological stress
Awards & highlights
Hypo fMRI Trial Summary
This trial will study the effects of low blood sugar on the nervous system to help reveal how non-psychological stress impacts the brain & autonomic nervous system.
Who is the study for?
This trial is for healthy men and women aged 18-45 with a BMI of 18-35. Participants must not have kidney issues, diabetes, severe depression or anxiety, metal implants, be pregnant or lactating, use tobacco or drugs, have abnormal heart readings or take certain medications.Check my eligibility
What is being tested?
The study tests how low blood sugar stress affects the nervous system by using two procedures: Normoglycemic Hyperinsulinemic Clamp to maintain normal blood sugar levels and Hypoglycemic Hyperinsulinemic Clamp to lower them.See study design
What are the potential side effects?
Possible side effects include discomfort at the infusion site from clamps used during the procedure. Low blood sugar can cause symptoms like dizziness, sweating, hunger, irritability or confusion.
Hypo fMRI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 45 years old.
Hypo fMRI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 8 hours after physiological stress, and 4 days after physiological stress
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8 hours after physiological stress, and 4 days after physiological stress
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effect of physiological stress (hypoglycemia) on brain networks involved in autonomic function
The relationship over time between stress-induced changes in brain networks and stress-induced changes in baroreflex sensitivity
Hypo fMRI Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: HypoglycemiaActive Control1 Intervention
Participants undergo Autonomic Nervous System (ANS) Testing (measurement of Baroreflex Sensitivity using the Modified Oxford test) followed by a functional MRI (fMRI) scan. The next day, participants undergo one 120-minute hypoglycemic hyperinsulinemic clamp procedure (50mg/dL) in the morning followed by ANS Testing and an fMRI scan. Four days later, participants undergo repeat ANS Testing and an fMRI scan.
Group II: NormoglycemiaPlacebo Group1 Intervention
Participants undergo Autonomic Nervous System (ANS) Testing (measurement of Baroreflex Sensitivity using the Modified Oxford test) followed by a functional MRI (fMRI) scan. The next day, participants undergo one 120-minute normoglycemic hyperinsulinemic clamp procedure (90mg/dL) in the morning followed by ANS Testing and an fMRI scan. Four days later, participants undergo repeat ANS Testing and an fMRI scan.
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterOTHER
836 Previous Clinical Trials
13,010,186 Total Patients Enrolled
Mclean HospitalOTHER
213 Previous Clinical Trials
21,650 Total Patients Enrolled
Boston Children's HospitalOTHER
761 Previous Clinical Trials
5,579,686 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is reduced.You have a body mass index (BMI) between 18 and 35.This criterion is too vague to provide a simplified summary. Can you please provide more specific information about the medical condition that needs to be summarized?I only use thyroid hormone or hormonal birth control.You have metal objects inside your body, like pacemakers, stents, or metal implants in your eyes.Your score on the depression questionnaire is 15 or higher.I have gone through menopause.Your hemoglobin A1c level is 6.5% or higher.Your ECG (electrocardiogram) shows abnormal results.You currently smoke or use tobacco products.People who are in good healthYour blood pressure is too high (above 140/90) or too low (below 100/90).Your score on the PTSD Checklist for DSM-5 is 31 or higher.Your stress level, as measured by a specific test, is higher than 28.You have a history of alcohol or drug abuse.Your blood potassium level is higher than 5.0 mmol/L.Your anxiety score on the GAD-7 questionnaire is 10 or higher.I am between 18 and 45 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Normoglycemia
- Group 2: Hypoglycemia
Awards:
This trial has 0 awards, including: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.
What is the current enrolment rate of participants for this research project?
"Affirmative, the information posted on clinicaltrials.gov reveal that this trial is still enrolling participants. It was first published on October 1st 2019 and underwent its last update on April 8th 2022. This endeavor must recruit 44 individuals from 2 clinics in order to be complete."
Answered by AI
Are there opportunities for individuals to participate in this experiment?
"Clinicaltrials.gov has information indicating that this medical trial is still recruiting participants; the study was initially published on October 1st 2019 and most recently amended on April 8th 2022."
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Does the trial include adults aged 20 and over?
"Through adherence to the trial criteria, only persons aged 18-45 are eligible for recruitment."
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Who meets the criteria for inclusion in this trial?
"Those wishing to partake in this clinical trial must be afflicted with stress, meet physiological criteria, and fall between 18-45 years of age. Additionally, only 44 participants will be accepted into the study."
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