Type 1 Diabetes Clinical Trial
Official title:
Exploring Immunologic Effects of Oral Insulin in Relatives at Risk for Type 1
Verified date | July 2020 |
Source | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is a 2 arm, multi-center, randomized, open-labeled clinical trial designed to assess the effects of varying doses and schedules of oral insulin on immunological and metabolic markers in relatives at risk for type 1 diabetes (T1D).
Status | Completed |
Enrollment | 92 |
Est. completion date | March 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Participants in TrialNet Natural History/Pathway to Prevention Study (TN01); is relative of proband with type 1 diabetes - Between ages 3-45 with normal Oral Glucose Tolerance Test (OGTT) or between ages 3-7 with an abnormal OGTT - Confirmed positive for insulin autoantibodies within previous six months - Confirmed positive for one or more other autoantibodies on two separate occasions within the past six months Exclusion Criteria: - Diagnosed with type 1 diabetes - History of treatment with insulin or oral hypoglycemic agent - History of therapy with immunosuppressive drugs or non-physiologic glucocorticoids within the past two years for a period of more than three months - Ongoing use of medications known to influence glucose tolerance - Pregnant or intending to become pregnant while on study or lactating |
Country | Name | City | State |
---|---|---|---|
Australia | Walter and Eliza Hall Institute of Medical Research | Parkville | Victoria |
Canada | The Hospital for Sick Children | Toronto | Ontario |
Italy | San Raffaele Hospital | Milan | |
United States | Emory Children's Center | Atlanta | Georgia |
United States | Barbara Davis Center for Childhood Diabetes | Aurora | Colorado |
United States | Joslin Diabetes Center | Boston | Massachusetts |
United States | University of Chicago | Chicago | Illinois |
United States | University of Texas Southwestern | Dallas | Texas |
United States | University of Florida | Gainesville | Florida |
United States | Baylor College of Medicine | Houston | Texas |
United States | Indiana University-Riley Hospital for Children | Indianapolis | Indiana |
United States | University of Miami | Miami | Florida |
United States | Vanderbilt University | Nashville | Tennessee |
United States | Columbia University-Naomi Berrie Diabetes Center | New York | New York |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | University of California - San Francisco | San Francisco | California |
United States | Benaroya Research Institute | Seattle | Washington |
United States | Stanford University | Stanford | California |
United States | University of South Florida | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Type 1 Diabetes TrialNet |
United States, Australia, Canada, Italy,
Bonifacio E, Ziegler AG, Klingensmith G, Schober E, Bingley PJ, Rottenkolber M, Theil A, Eugster A, Puff R, Peplow C, Buettner F, Lange K, Hasford J, Achenbach P; Pre-POINT Study Group. Effects of high-dose oral insulin on immune responses in children at high risk for type 1 diabetes: the Pre-POINT randomized clinical trial. JAMA. 2015 Apr 21;313(15):1541-9. doi: 10.1001/jama.2015.2928. — View Citation
Skyler JS, Krischer JP, Wolfsdorf J, Cowie C, Palmer JP, Greenbaum C, Cuthbertson D, Rafkin-Mervis LE, Chase HP, Leschek E. Effects of oral insulin in relatives of patients with type 1 diabetes: The Diabetes Prevention Trial--Type 1. Diabetes Care. 2005 May;28(5):1068-76. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in GAD65 Autoantibody Titer (DK Units/mL) | Change in T-lymphocyte (GAD65) biomarker of beta cell specific immune response | 13 and 26 weeks after first dose versus baseline | |
Primary | Change in mIAA Autoantibody Titer From Baseline | Micro-islet autoantibodies (mIAA) autoantibody titers are a measure of of beta cell immune response | 13 and 26 weeks after first dose versus baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05653518 -
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
|
N/A | |
Enrolling by invitation |
NCT05515939 -
Evaluating the InPen in Pediatric Type 1 Diabetes
|
||
Completed |
NCT05109520 -
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
|
||
Recruiting |
NCT04016987 -
Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT04190368 -
Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05413005 -
Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
|
Early Phase 1 | |
Active, not recruiting |
NCT04668612 -
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
|
N/A | |
Completed |
NCT02837094 -
Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
|
Phase 1 | |
Recruiting |
NCT05414409 -
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
|
Phase 2 | |
Recruiting |
NCT05670366 -
The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT05418699 -
Real-life Data From Diabetic Patients on Closed-loop Pumps
|
||
Completed |
NCT04084171 -
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
|
N/A | |
Recruiting |
NCT06144554 -
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
|
||
Recruiting |
NCT05379686 -
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05153070 -
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
|
Phase 2 | |
Completed |
NCT05281614 -
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
|
Early Phase 1 | |
Withdrawn |
NCT04259775 -
Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT01600924 -
Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
|
||
Completed |
NCT02914886 -
Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS)
|
Phase 4 | |
Completed |
NCT02855307 -
Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
|
Phase 2 |