search
Back to results

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

Primary Purpose

Type I Diabetes

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Type I Diabetes focused on measuring Imaging, Type 1 Diabetes Mellitus (T1DM), Islet, B Cell Mass, Pet Scan, Type 1 Diabetes, T1DM, Pancreas, Healthy Volunteer, HV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA Patients with T1DM inclusion criteria: Age greater than 18 History consistent with T1DM non-obese (BMI less than 35 kg/m(2)), and normal insulin sensitivity (as judged by insulin requirements less than or equal to 0.8 unit/kg/day). Low C-Peptide (less than or equal to 0.6 ng/ml) Pancreas Transplant Patient inclusion criteria: Age greater than 18 History consistent with T1DM (as above) PRIOR to pancreas transplant. Normal pancreas allograft function for at least the preceding 1 year. No acute rejection episodes within the past year. Control Patient inclusion criteria: Age greater than 18 No history of diabetes. Fasting blood glucose less than 100 mg/dl. Normal oral glucose tolerance. BMI less than 35 kg/m(2) Exclusion criteria for all: Liver dysfunction as determined by history, physical examination, and standard liver function testing (abnormal values for AST, ALT, Total/Direct Bilirubin, Alkaline Phosphatase) Coagulopathy Pregnancy Current breast feeding Use of MAO inhibitors or Levodopa Patients with a contraindication to MRI scanning.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 12, 2006
Last Updated
June 30, 2017
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT00351650
Brief Title
Assessment of Beta Cell Mass in Type 1 Diabetes With 11C-Dihydrotetrabenazine and PET Scan
Official Title
Assessment of Beta Cell Mass in Type 1 Diabetes With 11C-Dihydrotetrabenazine and PET Scan
Study Type
Observational

2. Study Status

Record Verification Date
February 6, 2008
Overall Recruitment Status
Completed
Study Start Date
July 9, 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 6, 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. Study Description

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.
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 individual's 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 gland's 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type I Diabetes
Keywords
Imaging, Type 1 Diabetes Mellitus (T1DM), Islet, B Cell Mass, Pet Scan, Type 1 Diabetes, T1DM, Pancreas, Healthy Volunteer, HV

7. Study Design

Enrollment
30 (false)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA Patients with T1DM inclusion criteria: Age greater than 18 History consistent with T1DM non-obese (BMI less than 35 kg/m(2)), and normal insulin sensitivity (as judged by insulin requirements less than or equal to 0.8 unit/kg/day). Low C-Peptide (less than or equal to 0.6 ng/ml) Pancreas Transplant Patient inclusion criteria: Age greater than 18 History consistent with T1DM (as above) PRIOR to pancreas transplant. Normal pancreas allograft function for at least the preceding 1 year. No acute rejection episodes within the past year. Control Patient inclusion criteria: Age greater than 18 No history of diabetes. Fasting blood glucose less than 100 mg/dl. Normal oral glucose tolerance. BMI less than 35 kg/m(2) Exclusion criteria for all: Liver dysfunction as determined by history, physical examination, and standard liver function testing (abnormal values for AST, ALT, Total/Direct Bilirubin, Alkaline Phosphatase) Coagulopathy Pregnancy Current breast feeding Use of MAO inhibitors or Levodopa Patients with a contraindication to MRI scanning.
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11216655
Citation
Malaisse WJ, Ladriere L, Sener A. Pancreatic fate of 6-deoxy-6-[125I]iodo-D-glucose: in vitro experiments. Endocrine. 2000 Dec;13(3):411-6.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs