- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04164966
Development of Novel Biomarkers for the Early Diagnosis of Type 1 Diabetes (HONEY)
February 5, 2024 updated by: AdventHealth Translational Research Institute
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Recruitment Department
- Phone Number: 407-303-7100
- Email: Fh.tri.recruitment@adventhealth.com
Study Locations
-
-
Florida
-
Orlando, Florida, United States, 32804
- Recruiting
- AdventHealth Translational Research Institute
-
Contact:
- Recruitment Department
- Phone Number: 407-303-7100
- Email: Fh.tri.recruitment@adventhealth.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
New onset Type 1 Diabetes
|
Healthy Normal Volunteers (HNV)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2-3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Richard Pratley, MD, Study Principal Investigator
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 27, 2019
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
November 13, 2019
First Submitted That Met QC Criteria
November 13, 2019
First Posted (Actual)
November 15, 2019
Study Record Updates
Last Update Posted (Actual)
February 6, 2024
Last Update Submitted That Met QC Criteria
February 5, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1459977
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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