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

NCT00351650 | Completed

• 2 other identifiers: 06019506-DK-0195
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Type I Diabetes

Keywords

Imaging; Type 1 Diabetes Mellitus (T1DM); Islet; B Cell Mass; Pet Scan; Type 1 Diabetes; T1DM; Pancreas; Healthy Volunteer; HV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• 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.

  PMID: 11216655 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 12, 2006
• First Posted: July 13, 2006
• Study Start: July 9, 2006
• Study Completion: February 6, 2008
• Last Updated: July 2, 2017

Record last verified: 2008-02-06

Locations

US (1)