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NCT00590876 · ClinicalTrials.gov registry record

The Impact of Pancreatic Islet Cell Allotransplantation on Cognitive Function in Type 1 Diabetes Mellitus

A clinical trial, sponsored by Yale University.

Completed
Registry status
36
Enrollment target

NCT00590876: Completed study, sponsored by Yale University.

NCT00590876 is a clinical trial that has completed, run by Yale University. The registered enrollment target is 36 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00590876 has completed, sponsored by Yale University.

COMPLETED
Registry status
36 participants
Enrollment target

Study Summary

In patients with Type 1 Diabetes Mellitus, hypoglycemia (low blood sugar) is the rate-limiting step to achieve glucose level control. As a result, understanding the body's responses (including the brain's response) to hypoglycemia is essential for the effective treatment of patients with T1DM. The purpose of this research is to determine whether pancreatic islet cell allotransplantation to restore normoglycemia (normal blood glucose levels) in Type 1 Diabetic patients with hypoglycemia unawareness alters brain fuel utilization and cognitive performance under euglycemic (blood sugar at 100 mg/dl) and hypoglycemic (blood sugar at 50 mg/dl) conditions. Three groups of subjects will be studied: (1) T1DM patients with a history of severe hypoglycemia and/or hypoglycemia unawareness who have been selected for pancreatic islet cell allotransplantation; (2) T1DM patients who also have a history of severe hypoglycemia and/or hypoglycemia unawareness; (3) nondiabetic subjects. All subjects will undergo identical testing including: (a) screening; (b) neuropsychological testing; (c) and functional magnetic resonance imaging (fMRI) during euglycemic and hypoglycemic conditions.

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2008-12
Est. Completion 2011-07
Yale University

1,492 total trials

What the finished NCT00590876 record still lists

NCT00590876 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 36 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT00590876 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00590876 about?

NCT00590876 is a clinical study titled "The Impact of Pancreatic Islet Cell Allotransplantation on Cognitive Function in Type 1 Diabetes Mellitus". In patients with Type 1 Diabetes Mellitus, hypoglycemia (low blood sugar) is the rate-limiting step to achieve glucose level control. As a result, understanding the body's responses (including the brain's response) to hypoglycemia is essential for the effective treatment of patients with T1DM. The p...

What is the current status of trial NCT00590876?

This trial is currently completed. The enrollment target is 36 participants. The study started on 2008-12. Estimated completion is 2011-07.

Who is sponsoring clinical trial NCT00590876?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00590876, the US trial registry maintained by the National Library of Medicine. NCT00590876 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.