Status:
ACTIVE_NOT_RECRUITING
Recurrent Hypoglycemia in Type 1 Diabetes (Aim 2)
Lead Sponsor:
University of Minnesota
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study will explore the cerebral mechanisms of impaired awareness of hypoglycemia (IAH) in type 1 diabetics following exposure to experimental recurrent hypoglycemia (HG). To induce IAH, patients ...
Detailed Description
The long-term goal of this project is to identify how recurrent hypoglycemia (HG) leads to the clinical syndrome of impaired awareness of hypoglycemia (IAH) in type 1 diabetes (T1D). This study will ...
Eligibility Criteria
Inclusion
- Type 1 diabetes diagnosed on clinical or laboratory grounds
- Diabetes duration 2 - 30 years
- Hemoglobin A1C \<8.5%
Exclusion
- Impaired awareness of hypoglycemia as determined by the Cox and Gold questionnaires
- Pregnant or plan to become pregnant during the study period
- Uncontrolled hypertension (blood pressure \> 145/95 mmHg at screening)
- Evidence of autonomic neuropathy (presence of orthostatic hypotension or history of gastroparesis)
- Proliferative retinopathy
- Impaired kidney function (GFR \< 45)
- History of myocardial infarction, stroke, seizures, neurosurgical procedures, major depression requiring hospitalization within the last 5 years, arrhythmias
- Current substance abuse
- Use of drugs that can alter glucose metabolism including but not limited to glucocorticoids and niacin, and excluding insulin and glucose lowering drugs used to treat diabetes, as determined by a clinician
- Inability to undergo MRI scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs
- Unable to complete all study visits or procedures, as determined by the investigator
Key Trial Info
Start Date :
August 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04387422
Start Date
August 12 2020
End Date
December 1 2028
Last Update
April 17 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455