The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04164966
Recruitment Status : **RECRUITING NOW**
First Posted : November 15, 2019
Last Update Posted : January 4, 2023
Sponsor:
Information provided by (Responsible Party):
AdventHealth Translational Research Institute
Go toÂ
Brief Summary:
The purpose of this study is to measure the levels of certain substances (biomarkers) in the body that may indicate the triggers of Type 1 Diabetes, to find a better way to diagnose the disease, as well as to follow its progression.
Type 1 Diabetes
Go toÂ
Layout table for study information
Study Type :
Observational
Estimated Enrollment :
20 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Development of Novel Biomarkers for the Early Diagnosis of Type 1 Diabetes
Actual Study Start Date :
November 27, 2019
Estimated Primary Completion Date :
June 2023
Estimated Study Completion Date :
June 2023
Resource links provided by the National Library of Medicine
Go toÂ
New onset Type 1 Diabetes
Healthy Normal Volunteers (HNV)
Go toÂ
Primary Outcome Measures :
Characterization of circulating β cell-specific exosomes in children with T1D and healthy normal controls using baseline samples [ Time Frame: 2-3 hours ]
Measure will be the number (concentration) of circulating beta-cell specific exosomes. If the characterization of circulating beta-cell specific exosomes is not feasible in children with T1D due to the potentially limited low input amount of this type of exosomes in the circulation of these participants, an alternative analysis will be implemented.
Go toÂ
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study: Â
12 Years to 18 Years  (Child, Adult)
Sexes Eligible for Study: Â
All
Accepts Healthy Volunteers: Â
Yes
Sampling Method: Â
Probability Sample
Males and females 12-18 years of age with a diagnosis of type 1 diabetes within the past 3 months or those who do not have diabetes.
Inclusion Criteria:
Type 1 Diabetes (T1D)
Age 12-18 years inclusive
Diagnosis of T1D according to American Diabetes Association (ADA) criteria with an acute onset and presence of islet associated autoantibody by history.
T1D duration of ≤ 3 months from the diagnosis
Healthy Normal Volunteers (HNV)
Age 12-18 years inclusive
No personal history of diabetes according to ADA criteria
No history of T1D or insulin treated diabetes in first degree relatives (FDR)
Exclusion Criteria:
Acute or chronic medical conditions or medication that would contraindicate the participation in the research testing or could potentially affect metabolic and immune function including, but not limited to:
History of type 2 diabetes
Suspicion of non-type 1 diabetes (e.g. maturity onset diabetes of the young or secondary diabetes)
History of thyroid dysfunction in which the participant has not been on a stable dose (at least 6 weeks prior to enrollment) of thyroid replacement medication or antithyroid drugs.
History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable).
History of organ transplant
History of HIV, active Hepatitis B or C, or Tuberculosis
Pregnancy, lactation or 6 months postpartum from the scheduled date of collection
Psychiatric disease prohibiting adherence to study protocol
Use of oral or injectable anti-hyperglycemic agents: metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, thiazolidinediones, acarbose, GLP-1 analogs.
Use of any other medications known to influence glucose, fat and/or energy metabolism within the last 3 months (e.g., growth hormone therapy, glucocorticoids [steroids], prescribed medications for weight loss, etc.)
Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant’s ability to complete study visits
Go toÂ
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04164966
Layout table for location information
AdventHealth Translational Research Institute
Orlando, Florida, United States, 32804
Contact: Recruitment Department   407-303-7100   Fh.tri.recruitment@adventhealth.com  Â
AdventHealth Translational Research Institute
Layout table for investigator information
Principal Investigator:
Richard Pratley, MD
Study principal investigator
Go toÂ
Imperatore G, Boyle JP, Thompson TJ, Case D, Dabelea D, Hamman RF, Lawrence JM, Liese AD, Liu LL, Mayer-Davis EJ, Rodriguez BL, Standiford D; SEARCH for Diabetes in Youth Study Group. Projections of type 1 and type 2 diabetes burden in the U.S. population aged <20 years through 2050: dynamic modeling of incidence, mortality, and population growth. Diabetes Care. 2012 Dec;35(12):2515-20. doi: 10.2337/dc12-0669.
Dabelea D, Mayer-Davis EJ, Saydah S, Imperatore G, Linder B, Divers J, Bell R, Badaru A, Talton JW, Crume T, Liese AD, Merchant AT, Lawrence JM, Reynolds K, Dolan L, Liu LL, Hamman RF; SEARCH for Diabetes in Youth Study. Prevalence of type 1 and type 2 diabetes among children and adolescents from 2001 to 2009. JAMA. 2014 May 7;311(17):1778-86. doi: 10.1001/jama.2014.3201.
Freeman DW, Noren Hooten N, Eitan E, Green J, Mode NA, Bodogai M, Zhang Y, Lehrmann E, Zonderman AB, Biragyn A, Egan J, Becker KG, Mattson MP, Ejiogu N, Evans MK. Altered Extracellular Vesicle Concentration, Cargo, and Function in Diabetes. Diabetes. 2018 Nov;67(11):2377-2388. doi: 10.2337/db17-1308. Epub 2018 May 2.
Ying W, Riopel M, Bandyopadhyay G, Dong Y, Birmingham A, Seo JB, Ofrecio JM, Wollam J, Hernandez-Carretero A, Fu W, Li P, Olefsky JM. Adipose Tissue Macrophage-Derived Exosomal miRNAs Can Modulate In Vivo and In Vitro Insulin Sensitivity. Cell. 2017 Oct 5;171(2):372-384.e12. doi: 10.1016/j.cell.2017.08.035. Epub 2017 Sep 21.
Cianciaruso C, Phelps EA, Pasquier M, Hamelin R, Demurtas D, Alibashe Ahmed M, Piemonti L, Hirosue S, Swartz MA, De Palma M, Hubbell JA, Baekkeskov S. Primary Human and Rat beta-Cells Release the Intracellular Autoantigens GAD65, IA-2, and Proinsulin in Exosomes Together With Cytokine-Induced Enhancers of Immunity. Diabetes. 2017 Feb;66(2):460-473. doi: 10.2337/db16-0671. Epub 2016 Nov 21.
Korutla L, Rickels MR, Hu RW, Freas A, Reddy S, Habertheuer A, Harmon J, Korutla V, Ram C, Naji A, Vallabhajosyula P. Noninvasive diagnosis of recurrent autoimmune type 1 diabetes after islet cell transplantation. Am J Transplant. 2019 Jun;19(6):1852-1858. doi: 10.1111/ajt.15322. Epub 2019 Mar 18.
Layout table for additonal information
Responsible Party:
AdventHealth Translational Research Institute
ClinicalTrials.gov Identifier:
NCT04164966 Â Â
Other Study ID Numbers:
1459977
First Posted:
November 15, 2019 Â Â Key Record Dates
Last Update Posted:
January 4, 2023
Last Verified:
January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
No
Layout table for additional information
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes MellitusDiabetes Mellitus, Type 1Glucose Metabolism DisordersMetabolic Diseases
Endocrine System DiseasesAutoimmune DiseasesImmune System Diseases
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
