Prematurity Prevalence Among T1D Patients and Its Characteristics Compared With Premature-born Non-diabetic Patients
NCT ID: NCT02929953
Last Updated: 2019-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3600 participants
OBSERVATIONAL
2014-01-31
2019-04-30
Brief Summary
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1. To assess the prevalence of prematurity, especially early prematurity, among T1D patients, and compare it to the prematurity prevalence among the non-diabetic general population in Israel.
2. To characterize epidemiological and clinical factors that differ between premature-born patients that developed T1D and those that have not, including the nutritional and therapeutic properties in NICU.
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Detailed Description
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In the latter part of the study, a multi-centered, paired case-control study is performed.
Preterm born T1D patients will be paired to matched non-diabetic children at a ratio of 3:1, according to medical center, sex, gestational week of birth, season and year of birth. Data collected includes: ethnicity, family history of autoimmune diseases, age and type of first enteral nutrition, and pharmacological exposures.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Diabetes mellitus type 1
all T1DM patients in Israel, born during 2000-2013 and diagnosed prior to January 2015.
chart review
chart review
data from charts and from registries will be compared
Non-diabetic
non-diabetic general population born in Israel during 2000-2013, according to the Israeli Health Ministry's Birth Registry (IHMBR) chart review
chart review
data from charts and from registries will be compared
Interventions
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chart review
data from charts and from registries will be compared
Eligibility Criteria
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Inclusion Criteria
2. Patients treated in one of the 13 participating centers
3. For the case-control portion of the study, all children born between 1.1.1990-31.12.2013 and admitted to NICU medical centers that have been included in the original cohort portion
4. Patients for whom a complete medical record is available
Exclusion Criteria
2. Unknown type of diabetes
3. For case control portion, an incomplete medical record/inadequate documentation
1 Year
25 Years
ALL
No
Sponsors
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Shaare Zedek Medical Center
OTHER
Wolfson Medical Center
OTHER_GOV
Ziv Medical Center
OTHER
Schneider Children's Medical Center, Israel
OTHER
Tel-Aviv Sourasky Medical Center
OTHER_GOV
Maccabi Healthcare Services, Israel
OTHER
Kaplan Medical Center
OTHER
HaEmek Medical Center, Israel
OTHER
Soroka University Medical Center
OTHER
Rambam Health Care Campus
OTHER
Hadassah Medical Organization
OTHER
Assaf Harofeh MC
OTHER_GOV
Responsible Party
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Assaf Harofeh MC
Assaf-Harofeh Medical Center
Principal Investigators
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marianna Rachmiel, md
Role: PRINCIPAL_INVESTIGATOR
Assaf Haroffeh Medical Center
Locations
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Assaf Harofeh Medical Center
Ẕerifin, , Israel
Countries
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References
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Blumenfeld O, Dichtiar R, Shohat T; Israel IDDM Registry Study Group (IIRSG). Trends in the incidence of type 1 diabetes among Jews and Arabs in Israel. Pediatr Diabetes. 2014 Sep;15(6):422-7. doi: 10.1111/pedi.12101. Epub 2013 Nov 27.
Egro FM. Why is type 1 diabetes increasing? J Mol Endocrinol. 2013 Jul 12;51(1):R1-13. doi: 10.1530/JME-13-0067. Print 2013.
De Curtis M, Rigo J. The nutrition of preterm infants. Early Hum Dev. 2012 Mar;88 Suppl 1:S5-7. doi: 10.1016/j.earlhumdev.2011.12.020. Epub 2012 Jan 17.
Working Group Of Pediatrics Chinese Society Of Parenteral And Enteral Nutrition, Working Group Of Neonatology Chinese Society Of Pediatrics, Working Group Of Neonatal Surgery Chinese Society Of Pediatric Surgery. CSPEN guidelines for nutrition support in neonates. Asia Pac J Clin Nutr. 2013;22(4):655-63. doi: 10.6133/apjcn.2013.22.4.21.
Kagohashi Y, Otani H. Role of nutritional factors at the early life stages in the pathogenesis and clinical course of type 1 diabetes. Biomed Res Int. 2015;2015:382165. doi: 10.1155/2015/382165. Epub 2015 Mar 26.
Ziegler AG, Pflueger M, Winkler C, Achenbach P, Akolkar B, Krischer JP, Bonifacio E. Accelerated progression from islet autoimmunity to diabetes is causing the escalating incidence of type 1 diabetes in young children. J Autoimmun. 2011 Aug;37(1):3-7. doi: 10.1016/j.jaut.2011.02.004. Epub 2011 Mar 3.
Jaberi-Douraki M, Liu SW, Pietropaolo M, Khadra A. Autoimmune responses in T1DM: quantitative methods to understand onset, progression, and prevention of disease. Pediatr Diabetes. 2014 May;15(3):162-74. doi: 10.1111/pedi.12148.
Walker WA. Initial intestinal colonization in the human infant and immune homeostasis. Ann Nutr Metab. 2013;63 Suppl 2:8-15. doi: 10.1159/000354907. Epub 2013 Nov 8.
Kemppainen KM, Ardissone AN, Davis-Richardson AG, Fagen JR, Gano KA, Leon-Novelo LG, Vehik K, Casella G, Simell O, Ziegler AG, Rewers MJ, Lernmark A, Hagopian W, She JX, Krischer JP, Akolkar B, Schatz DA, Atkinson MA, Triplett EW; TEDDY Study Group. Early childhood gut microbiomes show strong geographic differences among subjects at high risk for type 1 diabetes. Diabetes Care. 2015 Feb;38(2):329-32. doi: 10.2337/dc14-0850. Epub 2014 Dec 17.
Kostic AD, Gevers D, Siljander H, Vatanen T, Hyotylainen T, Hamalainen AM, Peet A, Tillmann V, Poho P, Mattila I, Lahdesmaki H, Franzosa EA, Vaarala O, de Goffau M, Harmsen H, Ilonen J, Virtanen SM, Clish CB, Oresic M, Huttenhower C, Knip M; DIABIMMUNE Study Group; Xavier RJ. The dynamics of the human infant gut microbiome in development and in progression toward type 1 diabetes. Cell Host Microbe. 2015 Feb 11;17(2):260-73. doi: 10.1016/j.chom.2015.01.001. Epub 2015 Feb 5.
Zeitlin J, Szamotulska K, Drewniak N, Mohangoo AD, Chalmers J, Sakkeus L, Irgens L, Gatt M, Gissler M, Blondel B; Euro-Peristat Preterm Study Group. Preterm birth time trends in Europe: a study of 19 countries. BJOG. 2013 Oct;120(11):1356-65. doi: 10.1111/1471-0528.12281. Epub 2013 May 24.
Soll RF, Edwards WH. Antibiotic use in neonatal intensive care. Pediatrics. 2015 May;135(5):928-9. doi: 10.1542/peds.2015-0707. No abstract available.
Li S, Zhang M, Tian H, Liu Z, Yin X, Xi B. Preterm birth and risk of type 1 and type 2 diabetes: systematic review and meta-analysis. Obes Rev. 2014 Oct;15(10):804-11. doi: 10.1111/obr.12214. Epub 2014 Jul 30.
Cardwell CR, Carson DJ, Patterson CC. Parental age at delivery, birth order, birth weight and gestational age are associated with the risk of childhood Type 1 diabetes: a UK regional retrospective cohort study. Diabet Med. 2005 Feb;22(2):200-6. doi: 10.1111/j.1464-5491.2005.01369.x.
Crump C, Winkleby MA, Sundquist K, Sundquist J. Risk of diabetes among young adults born preterm in Sweden. Diabetes Care. 2011 May;34(5):1109-13. doi: 10.2337/dc10-2108. Epub 2011 Mar 16.
Algert CS, McElduff A, Morris JM, Roberts CL. Perinatal risk factors for early onset of Type 1 diabetes in a 2000-2005 birth cohort. Diabet Med. 2009 Dec;26(12):1193-7. doi: 10.1111/j.1464-5491.2009.02878.x.
Capasso L, Borrelli A, Cerullo J, Pisanti R, Figliuolo C, Izzo F, Paccone M, Ferrara T, Lama S, Raimondi F. Role of immunoglobulins in neonatal sepsis. Transl Med UniSa. 2014 Dec 19;11:28-33. eCollection 2015 Jan-Apr.
Gritz EC, Bhandari V. The human neonatal gut microbiome: a brief review. Front Pediatr. 2015 Mar 5;3:17. doi: 10.3389/fped.2015.00017. eCollection 2015.
Arboleya S, Sanchez B, Milani C, Duranti S, Solis G, Fernandez N, de los Reyes-Gavilan CG, Ventura M, Margolles A, Gueimonde M. Intestinal microbiota development in preterm neonates and effect of perinatal antibiotics. J Pediatr. 2015 Mar;166(3):538-44. doi: 10.1016/j.jpeds.2014.09.041. Epub 2014 Oct 25.
Modi SR, Collins JJ, Relman DA. Antibiotics and the gut microbiota. J Clin Invest. 2014 Oct;124(10):4212-8. doi: 10.1172/JCI72333. Epub 2014 Oct 1.
Uusitalo U, Liu X, Yang J, Aronsson CA, Hummel S, Butterworth M, Lernmark A, Rewers M, Hagopian W, She JX, Simell O, Toppari J, Ziegler AG, Akolkar B, Krischer J, Norris JM, Virtanen SM; TEDDY Study Group. Association of Early Exposure of Probiotics and Islet Autoimmunity in the TEDDY Study. JAMA Pediatr. 2016 Jan;170(1):20-8. doi: 10.1001/jamapediatrics.2015.2757.
Adar A, Shalitin S, Eyal O, Loewenthal N, Pinhas-Hamiel O, Levy M, Dally-Gottfried O, Landau Z, Zung A, Levy-Khademi F, Zangen D, Tenenbaum-Rakover Y, Rachmiel M. Prevalence of early and late prematurity is similar among pediatric type 1 diabetes patients and the general population. Diabetes Metab Res Rev. 2018 Jul;34(5):e2996. doi: 10.1002/dmrr.2996. Epub 2018 Mar 24.
Other Identifiers
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183/13
Identifier Type: -
Identifier Source: org_study_id
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