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NCT04387422 · ClinicalTrials.gov registry record · NA
Recurrent Hypoglycemia in Type 1 Diabetes (Aim 2)
A NA study of Diabetes Mellitus, Type 1, sponsored by University of Minnesota.
- Active
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT04387422: Active NA study of Diabetes Mellitus, Type 1, sponsored by University of Minnesota.
NCT04387422 is a NA study of Diabetes Mellitus, Type 1 that is active but no longer recruiting, run by University of Minnesota. The registered enrollment target is 50 participants, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04387422, a NA study of Diabetes Mellitus, Type 1, is active but no longer recruiting, sponsored by University of Minnesota.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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 with T1D identified to have normal awareness of hypoglycemia (NAH) will undergo three 2-hour long hypoglycemic clamps. Neurochemical profiles will be measured by high field MRS before and after induction of IAH. Subject glycemic variability and activity/sleep for 1 week before each study will be monitored as all factors have been shown to alter responses to HG.
Primary Outcome
A kinetic model of glucose transport through the blood-brain-barrier (BBB) via reversible symmetric Michaelis-Menten kinetics and irreversible utilization in brain tissue will be utilized. The kinetics of glucose transport into and utilization in the frontal cortex will be quantified using dynamic modeling to extract the Michaelis-Menten constants and the maximal rate for glucose transport and utilization. The ratio of maximal transport rate to cerebral metabolic rate of glucose will be estimate
Conditions Studied
Interventions
- OTHER Experimental hyperglycemia
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-08-12 |
| Est. Completion | 2028-12 |
| Phase | NA |
What the registry record for NCT04387422 still lists
NCT04387422 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 1 intervention - of which Experimental hyperglycemia is the first listed.
NCT04387422 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT04387422 about?
NCT04387422 is a clinical study titled "Recurrent Hypoglycemia in Type 1 Diabetes (Aim 2)". 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 with T1D identified to have normal awareness of hypoglycemia (NAH) will undergo three 2-hour long hy...
What is the current status of trial NCT04387422?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2020-08-12. Estimated completion is 2028-12.
What conditions does trial NCT04387422 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT04387422?
The interventions under investigation include: Experimental hyperglycemia (OTHER).
Who is sponsoring clinical trial NCT04387422?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04387422 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04387422's enrollment target sits among peer trials
50 70th of 118 higher than 44 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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