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Experimental Hyperglycemia for Type 1 Diabetes

N/A
Waitlist Available
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
Must not have
Evidence of autonomic neuropathy (presence of orthostatic hypotension or history of gastroparesis)
Impaired kidney function (GFR < 45)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 240 minutes
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I have been diagnosed with Type 1 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have symptoms like dizziness when standing up or slow stomach emptying.
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My kidney function is reduced.
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I haven't had a heart attack, stroke, seizures, major depression requiring hospitalization, or serious heart rhythm problems in the last 5 years.
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I have a condition where abnormal blood vessels grow in my retina.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~240 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 240 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Glucose kinetics during hyperglycemic clamps before and after induction of IAH
Secondary study objectives
Antecedent glycemia concentration
Antecedent physical activity - energy expenditure
Antecedent physical activity - light physical activity
+3 more

Awards & Highlights

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

Trial 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
1,428 Previous Clinical Trials
1,620,854 Total Patients Enrolled
Elizabeth R Seaquist, MDPrincipal InvestigatorUniversity of Minnesota
5 Previous Clinical Trials
429 Total Patients Enrolled

Media Library

Experimental hyperglycemia Clinical Trial Eligibility Overview. Trial Name: NCT04387422 — N/A
Type 1 Diabetes Research Study Groups: 300 mg/dL, 150 mg/dL, 225 mg/dL
Type 1 Diabetes Clinical Trial 2023: Experimental hyperglycemia Highlights & Side Effects. Trial Name: NCT04387422 — N/A
Experimental hyperglycemia 2023 Treatment Timeline for Medical Study. Trial Name: NCT04387422 — N/A
~24 spots leftby Dec 2028
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