Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00633763
Other study ID # 2007-5785
Secondary ID
Status Completed
Phase N/A
First received March 4, 2008
Last updated May 27, 2009
Start date February 2008
Est. completion date July 2008

Study information

Verified date May 2009
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The pancreas is an organ that plays major roles in the digestion of food. A part of the pancreas called islet beta-cells produces insulin, which regulates the amount of glucose (a sugar) present in the blood at all times. Type-1 Diabetes Mellitus (T1DM), an autoimmune disorder characterized by destruction of pancreatic islet beta-cells (the cells that produce insulin), affects at least a million individuals in the US alone. In T1DM, a type of white blood cells called T lymphocytes attacks and destroys the pancreatic islet beta-cells, leading to a loss of insulin, an increase in blood glucose, and a dependence on insulin injections for survival. Despite rigorous control of blood sugar, the majority of diabetic patients develop serious complications including retinopathy, nephropathy, neuropathy, microangiopathy and strokes.

Non-invasive methods to monitor pancreatic beta-cell loss associated with type-1 diabetes mellitus (T1DM) could improve early diagnosis, provide tools to measure responsiveness to new therapies, and evaluate the efficiency of pancreatic transplantation and graft survival.

Our goal is to develop a non-invasive PET-CT imaging method based on binding of a molecule (18F-fallypride) for tracking beta-cell loss during the progression of T1DM. In preliminary studies we demonstrated specific binding of 18F-fallypride to D2 receptors in rat pancreatic sections and we demonstrated that the loss of pancreatic beta cells in streptozotocin-treated rats was associated with a corresponding decrease in 18F-fallypride binding to pancreatic sections. A preliminary 18F-fallypride PET-CT study done by a collaborator in Ohio on a healthy volunteer, revealed 18F-fallypride-uptake by the pancreas that was distinguishable from surrounding tissues. Aim-1 of our project will measure the variability of 18F-fallypride PET-scanning of the pancreas in six healthy volunteers scanned twice with an interval of 4-6 weeks. In Aim-2 of our project, we will compare fallypride PET-CT scans of 12 patients with long-standing T1DM (nearly all beta cells destroyed) with 12 age- and sex-matched healthy volunteers. If we are able to distinguish between the two groups, we will in future (a) optimize the method so as to be able to detect a 20-30% loss of beta cells, and (b) perform PET-CT studies in new-onset T1DM patients and in at-risk first degree relatives of T1DM patients.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- T1DM patients that are over 18 years of age, have had T1DM for greater than 5 years and show a greater than 80% reduction in C-peptide blood levels following intravenous glucagon injection are eligible to participate in this study.

- Healthy controls that are over 18 years of age, show normal C-peptide blood levels following intravenous glucagon injection, and are age- and sex-matched with one of the T1DM patients included in the study, are eligible to participate in this study.

Exclusion Criteria:

- T1DM patients or healthy controls that are not over 18 years of age are not eligible to participate in this study.

- Pregnant females are not eligible to participate in this study because there is a chance PET/CT scans might be risky for the developing baby. Females physically capable of getting pregnant will be required to get a urine pregnancy test at no cost before each of the PET/CT scans. If the pregnancy test is positive, the T1DM patient or healthy control will be excluded from the study. The consent form describes the risks in detail and the need for women of childbearing age to undergo a pregnancy test.

- Subjects with a history of psychiatric illness, substance abuse history, clinically significant head trauma, active neurological disease, cardiovascular disease, liver disease or renal impairment, claustrophobia ((very upset and afraid of being in a small space) are not eligible for the study. Dr. Ping Wang will use the subjects history, blood chemistry, to identify individuals with cardiovascular disease, liver disease, or renal impairment.

- T1DM patients with C-peptide levels following intravenous glucagon injection that are not reduced greater than 80% are not eligible for the study.

- Healthy volunteers with C-peptide levels following intravenous glucagon injection that are reduced greater than 20% compared to established control values are not eligible for the study.

- To determine if it is safe to do the procedure, T1DM patients and healthy volunteers will be expected to tell the researchers about any radiation exposure the individual may have had (including diagnostic or treatment x-rays), and any history of head injury, kidney or bladder disease, or any other serious medical conditions.

- T1DM patients and healthy volunteers will be expected to tell the researchers if they have surgical clips or metallic prostheses (i.e., replacement body parts, such as a hip joint) or a pacemaker or other pieces of metal in the body (shrapnel, metal filings, etc.).

- Patients with history of alcoholism or significant alcohol consumption will be excluded from the study.

- The consent form will be English, and non-English speakers will therefore be excluded from the study.

- Pregnant women are excluded because 18F-fallypride is a radioactive substance , which will be injected into the patient and could be hazardous to the fetus.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Intervention

Drug:
18F-fallypride
Single bolus i.v. injection 60 minutes before PET-CT scanning. Maximum activity per single administration 5 mCi; maximum amount of drug per administration <10 micrograms.
18F-fallypride
I.v. bolus maximum activity per single administration 5 mCi; maximum amount of drug per administration <10 micrograms.

Locations

Country Name City State
United States University of California Irvine Medical Center Orange California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Irvine Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in fallypride binding in the pancreas of long-standing T1DM patients versus healthy controls At the end of the study when 12 controls and 12 patients have been studied. No
See also
  Status Clinical Trial Phase
Completed NCT03623113 - The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes N/A
Withdrawn NCT03396484 - Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes Phase 2
Completed NCT03117998 - Multiple Dose Study to Evaluate the Efficacy, Safety and Pharmacodynamics of REMD-477 in Subjects With Type 1 Diabetes Mellitus Phase 2
Recruiting NCT03369821 - EXtremely Early-onset Type 1 Diabetes EXtremely Early-onset Type 1 Diabetes (A Musketeers' Memorandum Study)
Completed NCT03202732 - DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes N/A
Completed NCT03704818 - Dapagliflozin Effects on Hypoglycemia Phase 1
Recruiting NCT03864991 - Lifestyle Changes and Glycemic Control in T1D N/A
Completed NCT03725657 - Correlation Between Exercise and Insulin Dose in a Camp for Pediatric Type 1 Patients
Completed NCT02985866 - The International Diabetes Closed Loop (iDCL) Trial: Protocol 1 N/A
Completed NCT03003806 - Evaluation of the Dreamed Advisor Pro for Automated Insulin Pump Setting Adjustments in Children and Adolescents With Type 1 Diabetes- The Advice4U Pro Study N/A
Withdrawn NCT04147637 - FreeStyle Libre Plus Bluetooth Transmitter Adjunct: Can This Improve Glucose Accuracy and Reduce Burden of Hypoglycaemia N/A
Completed NCT03970889 - Real-time Reminders To Decrease Late or Missed Meal Boluses N/A
Recruiting NCT04589325 - Ixekizumab Diabetes Intervention Trial (I-DIT) Phase 2
Completed NCT03367390 - A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM) Phase 1
Completed NCT03738852 - Mechanisms for Restoration of Hypoglycemia Awareness Early Phase 1
Completed NCT03406585 - Wharton´s Jelly Derived Mesenchymal Stromal Cell Treatment of Adult Patients Diagnosed With Type I Diabetes Phase 1/Phase 2
Completed NCT03859856 - Ovarian Reserve in Diabetes Mellitus
Withdrawn NCT04102202 - BOL-DP-o-05 as an Add-On Treatment of Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Phase 1/Phase 2
Terminated NCT03353792 - Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients N/A
Recruiting NCT03811470 - China Diabetes Registry by Metabolic Management Center