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NCT00351650 · ClinicalTrials.gov registry record

Assessment of Beta Cell Mass in Type 1 Diabetes With 11C-Dihydrotetrabenazine and PET Scan

A clinical trial, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed
Registry status
30
Enrollment target

NCT00351650: Completed study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

NCT00351650 is a clinical trial that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00351650 has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

COMPLETED
Registry status
30 participants
Enrollment target

Study Summary

This study will test dihydrotetrabenazine, or 11C-DTBZ, a radioactive tracer, as an imaging agent in positron emission tomography (PET). That tracer may have the ability to noninvasively measure beta cell, that is, -cell mass (BCM) in humans. For researchers hoping to develop new treatments for diabetes mellitus, a method of measuring BCM is very important. In this study, researchers will determine if patients with Type 1 diabetes mellitus, who have almost no BCM, have much less pancreatic uptake of the tracer than do patients without diabetes. Patients ages 18 and older may be eligible for this study. Three groups will be studied: Participants who have Type 1 diabetes, those without diabetes, and those who have been successfully treated with a transplant of the pancreas or pancreas and kidney The study involves three sets of tests that can be done as an outpatient or after being admitted to the hospital. Patients will undergo a medical history and procedures including collection of blood (about 4 teaspoons), pregnancy test for women of childbearing age, magnetic resonance imaging (MRI) scan, PET scan, and tests involving arginine and glucose. Arginine is a substance that stimulates insulin release from the -cells. During the procedure, two intravenous (IV) lines are placed into the arms, one to administer arginine and the other to draw blood (about eight samples during 10 minutes). For the glucose test, patients will drink a solution of dextrose, a sugar, and blood samples will be taken over 2 hours from the IV lines. Some patients experience nausea after drinking the solution. Within 48 hours of either test or both, patients will be placed in the PET scan machine and given an injection of the radioactive material through an IV line. Blood samples of about one-half teaspoon will be drawn before the procedure starts and again every 10 seconds for the first 2 minutes and at several intervals, up to 60 minutes. Finally, patients will also an MRI scan, 30 to 60 minute

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2006-07-09
Est. Completion 2008-02-06

What the finished NCT00351650 record still lists

NCT00351650 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.

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

NCT00351650 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00351650 about?

NCT00351650 is a clinical study titled "Assessment of Beta Cell Mass in Type 1 Diabetes With 11C-Dihydrotetrabenazine and PET Scan". This study will test dihydrotetrabenazine, or 11C-DTBZ, a radioactive tracer, as an imaging agent in positron emission tomography (PET). That tracer may have the ability to noninvasively measure beta cell, that is, -cell mass (BCM) in humans. For researchers hoping to develop new treatments for diab...

What is the current status of trial NCT00351650?

This trial is currently completed. The enrollment target is 30 participants. The study started on 2006-07-09. Estimated completion is 2008-02-06.

Who is sponsoring clinical trial NCT00351650?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00351650, the US trial registry maintained by the National Library of Medicine. NCT00351650 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.