Type1 Diabetes Mellitus Clinical Trial
Official title:
PET-CT Scan Method to Monitor Pancreatic B-Cell Loss in Diabetes Mellitus
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.
n/a
Observational Model: Case Control, Time Perspective: Prospective
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
|