Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351650
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-07-12
Brief Title:
Assessment of Beta Cell Mass in Type 1 Diabetes With 11C-Dihydrotetrabenazine and PET Scan
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Assessment of Beta Cell Mass in Type 1 Diabetes With 11C-Dihydrotetrabenazine and PET Scan
Status:
COMPLETED
Status Verified Date:
2008-02-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 minutes long of the abdomen This test will be down within two weeks of the PET scan MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues During the scan patients will be asked to lie still on a table that slides into the tunnel of the scanner They will be given earplugs for the machine can be noisy Patients who have metal within their body that is not compatible with the MRI machine will be withdrawn from the study
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 minutes long of the abdomen This test will be down within two weeks of the PET scan MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues During the scan patients will be asked to lie still on a table that slides into the tunnel of the scanner They will be given earplugs for the machine can be noisy Patients who have metal within their body that is not compatible with the MRI machine will be withdrawn from the study
Detailed Description:
Diabetes is a metabolic disorder in which pancreatic insulin producing B-cells located in cell clusters called the islets of Langerhans no longer produce sufficient insulin to maintain an individuals blood sugar concentration within the normal range Insufficient B-cell function can be caused by an autoimmune killing of the B-cells in type 1 diabetes mellitus T1DM or by poorly understood mechanisms in type 2 diabetes mellitus T2DM Regardless of the underlying cause the development of new diabetes treatments is limited by our current inability to objectively measure B-cell mass
We propose testing a previously used clinical radioligand dihydrotetrabenazine DTBZ as a Positron Emission Tomography PET imaging agent for its ability to non-invasively measure B-cell mass in humans We will study 30 patients 10 with T1DM 10 with normal glucose homeostasis and 5 with a history of T1DM but successfully restored glucose homeostasis following whole pancreas transplantation Prior to the PET scans each patient will undergo metabolic testing to characterize their glucose homeostasis and insulin producing capacity The pancreas will be initially identified in each patient with high-resolution magnetic resonance imaging MRI Then using anatomical landmarks identified by the MRI the subject will undergo DTBZ-PET imaging We predict that the radioactivity signal in the pancreas from the DTBZ-PET images will be significantly different between control subjects and T1DM subjects Further we predict that the DTBZ-PET images obtained in individuals with functioning pancreas allografts and such patients have two pancreases- their native pancreas and their pancreas allografts will reveal signal intensities from the two glands that correlates closely with each glands insulin producing capacity Should these studies suggest DTBZ has merit as a beta cell imaging agent we will expand the study to include patients with T2DM
We propose testing a previously used clinical radioligand dihydrotetrabenazine DTBZ as a Positron Emission Tomography PET imaging agent for its ability to non-invasively measure B-cell mass in humans We will study 30 patients 10 with T1DM 10 with normal glucose homeostasis and 5 with a history of T1DM but successfully restored glucose homeostasis following whole pancreas transplantation Prior to the PET scans each patient will undergo metabolic testing to characterize their glucose homeostasis and insulin producing capacity The pancreas will be initially identified in each patient with high-resolution magnetic resonance imaging MRI Then using anatomical landmarks identified by the MRI the subject will undergo DTBZ-PET imaging We predict that the radioactivity signal in the pancreas from the DTBZ-PET images will be significantly different between control subjects and T1DM subjects Further we predict that the DTBZ-PET images obtained in individuals with functioning pancreas allografts and such patients have two pancreases- their native pancreas and their pancreas allografts will reveal signal intensities from the two glands that correlates closely with each glands insulin producing capacity Should these studies suggest DTBZ has merit as a beta cell imaging agent we will expand the study to include patients with T2DM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-DK-0195 | None | None | None |