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Completed No phase listed Observational Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT00590876

Public ClinicalTrials.gov record NCT00590876. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 2:30 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The Impact of Pancreatic Islet Cell Allotransplantation on Cognitive Function and Brain Fuel Utilization in Patients With Type 1 Diabetes and Hypoglycemia Unawareness

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00590876
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Yale University
Other
Enrollment
36 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2008
Primary completion
Jun 30, 2011
Completion
Jun 30, 2011
Last update posted
Oct 26, 2011

2008 – 2011

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Yale University School of Medicine New Haven Connecticut 06520
University of Minnesota Minneapolis Minnesota 55455

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00590876, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 26, 2011 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00590876 live on ClinicalTrials.gov.

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