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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04164966
Other study ID # 1459977
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 27, 2019
Est. completion date June 2024

Study information

Verified date February 2024
Source AdventHealth Translational Research Institute
Contact Recruitment Department
Phone 407-303-7100
Email Fh.tri.recruitment@adventhealth.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria: Type 1 Diabetes (T1D) 1. Age 12-18 years inclusive 2. Diagnosis of T1D according to American Diabetes Association (ADA) criteria with an acute onset and presence of islet associated autoantibody by history. 3. T1D duration of = 3 months from the diagnosis Healthy Normal Volunteers (HNV) 1. Age 12-18 years inclusive 2. No personal history of diabetes according to ADA criteria 3. 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: 1. History of type 2 diabetes 2. Suspicion of non-type 1 diabetes (e.g. maturity onset diabetes of the young or secondary diabetes) 3. 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. 4. History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable). 5. History of organ transplant 6. History of HIV, active Hepatitis B or C, or Tuberculosis 7. Pregnancy, lactation or 6 months postpartum from the scheduled date of collection 8. Psychiatric disease prohibiting adherence to study protocol 9. Use of oral or injectable anti-hyperglycemic agents: metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, thiazolidinediones, acarbose, GLP-1 analogs. 10. 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.) 11. 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

Study Design


Locations

Country Name City State
United States AdventHealth Translational Research Institute Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
AdventHealth Translational Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (19)

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. — View Citation

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. — View Citation

Deshpande AD, Harris-Hayes M, Schootman M. Epidemiology of diabetes and diabetes-related complications. Phys Ther. 2008 Nov;88(11):1254-64. doi: 10.2522/ptj.20080020. Epub 2008 Sep 18. — View Citation

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. — View Citation

Garcia-Contreras M, Shah SH, Tamayo A, Robbins PD, Golberg RB, Mendez AJ, Ricordi C. Plasma-derived exosome characterization reveals a distinct microRNA signature in long duration Type 1 diabetes. Sci Rep. 2017 Jul 20;7(1):5998. doi: 10.1038/s41598-017-05787-y. — View Citation

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. — View Citation

Jacobsen LM, Haller MJ, Schatz DA. Understanding Pre-Type 1 Diabetes: The Key to Prevention. Front Endocrinol (Lausanne). 2018 Mar 6;9:70. doi: 10.3389/fendo.2018.00070. eCollection 2018. — View Citation

Koliha N, Wiencek Y, Heider U, Jungst C, Kladt N, Krauthauser S, Johnston IC, Bosio A, Schauss A, Wild S. A novel multiplex bead-based platform highlights the diversity of extracellular vesicles. J Extracell Vesicles. 2016 Feb 19;5:29975. doi: 10.3402/jev.v5.29975. eCollection 2016. — View Citation

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. — View Citation

Lundberg RL, Marino KR, Jasrotia A, Maranda LS, Barton BA, Alonso LC, Nwosu BU. Partial clinical remission in type 1 diabetes: a comparison of the accuracy of total daily dose of insulin of <0.3 units/kg/day to the gold standard insulin-dose adjusted hemoglobin A1c of </=9 for the detection of partial clinical remission. J Pediatr Endocrinol Metab. 2017 Aug 28;30(8):823-830. doi: 10.1515/jpem-2017-0019. — View Citation

Nathan DM; DCCT/EDIC Research Group. The diabetes control and complications trial/epidemiology of diabetes interventions and complications study at 30 years: overview. Diabetes Care. 2014;37(1):9-16. doi: 10.2337/dc13-2112. — View Citation

Nunez Lopez YO, Pittas AG, Pratley RE, Seyhan AA. Circulating levels of miR-7, miR-152 and miR-192 respond to vitamin D supplementation in adults with prediabetes and correlate with improvements in glycemic control. J Nutr Biochem. 2017 Nov;49:117-122. doi: 10.1016/j.jnutbio.2017.08.007. Epub 2017 Aug 26. — View Citation

Nunez Lopez YO, Retnakaran R, Zinman B, Pratley RE, Seyhan AA. Predicting and understanding the response to short-term intensive insulin therapy in people with early type 2 diabetes. Mol Metab. 2019 Feb;20:63-78. doi: 10.1016/j.molmet.2018.11.003. Epub 2018 Nov 16. — View Citation

Robbins PD, Dorronsoro A, Booker CN. Regulation of chronic inflammatory and immune processes by extracellular vesicles. J Clin Invest. 2016 Apr 1;126(4):1173-80. doi: 10.1172/JCI81131. Epub 2016 Apr 1. — View Citation

Seyhan AA, Nunez Lopez YO, Xie H, Yi F, Mathews C, Pasarica M, Pratley RE. Pancreas-enriched miRNAs are altered in the circulation of subjects with diabetes: a pilot cross-sectional study. Sci Rep. 2016 Aug 25;6:31479. doi: 10.1038/srep31479. — View Citation

Sims EK, Evans-Molina C, Tersey SA, Eizirik DL, Mirmira RG. Biomarkers of islet beta cell stress and death in type 1 diabetes. Diabetologia. 2018 Nov;61(11):2259-2265. doi: 10.1007/s00125-018-4712-1. Epub 2018 Aug 15. — View Citation

Skyler JS, Greenbaum CJ, Lachin JM, Leschek E, Rafkin-Mervis L, Savage P, Spain L; Type 1 Diabetes TrialNet Study Group. Type 1 Diabetes TrialNet--an international collaborative clinical trials network. Ann N Y Acad Sci. 2008 Dec;1150:14-24. doi: 10.1196/annals.1447.054. — View Citation

Thery C, Zitvogel L, Amigorena S. Exosomes: composition, biogenesis and function. Nat Rev Immunol. 2002 Aug;2(8):569-79. doi: 10.1038/nri855. No abstract available. — View Citation

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. — View Citation

* Note: There are 19 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Characterization of circulating ß cell-specific exosomes in children with T1D and healthy normal controls using baseline samples 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. 2-3 hours
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