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Experimental Hyperglycemia for Type 1 Diabetes
N/A
Recruiting
Led By Elizabeth R Seaquist, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Type 1 diabetes diagnosed on clinical or laboratory grounds
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 240 minutes
Awards & highlights
Study Summary
This trial will study how T1D patients with normal awareness of hypoglycemia (NAH) respond to three 2-hour long hypoglycemic clamps. MRS will be used to measure neurochemical profiles before and after the clamps.
Who is the study for?
This trial is for people with Type 1 diabetes who've had it for 2-30 years and have a Hemoglobin A1C below 8.5%. It's not for those pregnant, with uncontrolled high blood pressure, substance abuse issues, unable to undergo MRI scans due to various reasons like claustrophobia or having certain implants, over 300 lbs., or with a history of serious heart conditions, depression requiring hospitalization, arrhythmias in the last five years.Check my eligibility
What is being tested?
The study tests how repeated low blood sugar episodes affect the brain's ability to detect hypoglycemia in Type 1 diabetics. Participants will experience controlled low blood sugar events while their brain responses are monitored using advanced imaging techniques.See study design
What are the potential side effects?
Potential side effects include discomfort from low blood sugar such as shakiness, sweating, confusion and possibly fainting during the hypoglycemic clamps. The MRI may cause discomfort for those who are claustrophobic or sensitive to lying still.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Type 1 diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 240 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~240 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glucose kinetics during hyperglycemic clamps before and after induction of IAH
Secondary outcome measures
Antecedent glycemia concentration
Antecedent physical activity - energy expenditure
Antecedent physical activity - light physical activity
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: 300 mg/dLExperimental Treatment1 Intervention
Hyperglycemia target of 300 mg/dL
Group II: 225 mg/dLExperimental Treatment1 Intervention
Hyperglycemia target of 225 mg/dL
Group III: 150 mg/dLExperimental Treatment1 Intervention
Hyperglycemia target of 150 mg/dL
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,380 Previous Clinical Trials
1,588,695 Total Patients Enrolled
Elizabeth R Seaquist, MDPrincipal InvestigatorUniversity of Minnesota
5 Previous Clinical Trials
432 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking medication that affects my blood sugar, except for diabetes treatment.I have symptoms like dizziness when standing up or slow stomach emptying.My kidney function is reduced.You have trouble recognizing when your blood sugar is too low.You cannot have an MRI scan due to difficulty staying still, feeling claustrophobic, having certain metal objects in your body, or being over 300 lbs.You are currently using drugs or alcohol excessively.I haven't had a heart attack, stroke, seizures, major depression requiring hospitalization, or serious heart rhythm problems in the last 5 years.Your average blood sugar level (Hemoglobin A1C) is less than 8.5%.I have had diabetes for 2 to 30 years.Your blood pressure is too high and not being managed well.I have been diagnosed with Type 1 diabetes.I have a condition where abnormal blood vessels grow in my retina.
Research Study Groups:
This trial has the following groups:- Group 1: 300 mg/dL
- Group 2: 150 mg/dL
- Group 3: 225 mg/dL
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.
Does this experimental protocol allow for individuals over the age of 70 to partake?
"As indicated in the study's criteria for inclusion, potential participants should be aged 18 to 65 years."
Answered by AI
Do I fulfill the criteria to partake in this study?
"For this trial, 50 individuals with diabetes and another autoimmune disorder between 18-65 years of age qualify for enrollment. Most importantly, their condition must have been present for a period ranging from 2 to 30 years."
Answered by AI
Are there currently any open recruitment opportunities for this investigation?
"Affirmative. The information displayed on clinicaltrials.gov indicates that this medical trial has been recruiting since August 12th 2020, as per its latest update which was posted on September 29th 2022. This investigation requires the enrollment of 50 participants from 1 site."
Answered by AI
How many individuals are being monitored in the current experiment?
"Affirmative. The clinical trial, which was initially posted on August 12th 2020 and recently edited on September 29th 2022, is actively seeking participants as stated by the data hosted on clinicaltrials.gov. 50 patients need to be recruited from one medical facility."
Answered by AI
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