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| Name | Class |
|---|---|
| Shaare Zedek Medical Center | OTHER |
| Wolfson Medical Center | OTHER_GOV |
| Ziv Medical Center | OTHER |
| Schneider Children's Medical Center, Israel |
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The aims of this study are:
A national cohort study, including linkage of data from 13 pediatric diabetes centers and Israeli National Registries, including all patients with T1D born during 1990-2013. Data collected includes: ethnicity, gestational age, birth season, age and season at T1DM diagnosis, and presence of autoimmunity in family. The prevalence of prematurity among T1D is compared to the non-diabetic general population registry of 2000-2013. Additional comparisons are between T1D patients born term and preterm, aimed to unveil specific influencing clinical and epidemiological factors.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes mellitus type 1 | all T1DM patients in Israel, born during 2000-2013 and diagnosed prior to January 2015. chart review |
| |
| Non-diabetic | non-diabetic general population born in Israel during 2000-2013, according to the Israeli Health Ministry's Birth Registry (IHMBR) chart review |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chart review | Other | data from charts and from registries will be compared |
|
| Measure | Description | Time Frame |
|---|---|---|
| prematurity prevalence among T1D patients | the number of premature born among those with type 1 diaetes compared to prematurity in health non diabetic population | 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| food exposure of premature who developed T1DM compared with prematures who did not develop diabetes | 75 files of premies with T1DM will be ccompared to 225 charts of premies, non diabetic for age of food initiation | 1 years |
| Medications exposure in premature who developed T1DM compared with prematures who did not develop diabetes |
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Inclusion Criteria:
Exclusion Criteria:
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All T1D patients in Israel, born during 1990-2013 and diagnosed prior to January 2015, time of data collection. Inclusion criteria included all patients diagnosed as T1D by a pediatric endocrinologist according to the American Diabetes Association criteria, and treated for their T1D with insulin. Patients are identified from registries of the 13 participating centers.
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| Name | Affiliation | Role |
|---|---|---|
| marianna Rachmiel, md | Assaf Haroffeh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf Harofeh Medical Center | Ẕerifin | 70300 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24283719 | Background | 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. | |
| 23733895 | Background | 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. |
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IPD data will not be available for anyone other than the PI and co-investigators.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
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75 files of premies with T1DM will be ccompared to 225 charts of premies, non diabetic for age and type of drugs initiation |
| 1 years |
| 22261289 | Background | 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. |
| 24231027 | Background | 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. |
| 25883958 | Background | 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. |
| 21376535 | Background | 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. |
| 24827702 | Background | 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. |
| 24217032 | Background | 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. |
| 25519450 | Background | 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. |
| 25662751 | Background | 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. |
| 23700966 | Background | 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. |
| 25896842 | Background | 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. |
| 25073871 | Background | 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. |
| 15660739 | Background | 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. |
| 21411504 | Background | 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. |
| 20002469 | Background | 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. |
| 25674546 | Background | 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. |
| 25798435 | Background | 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. |
| 25444008 | Background | 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. |
| 25271726 | Background | 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. |
| 26552054 | Background | 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. |
| 29471580 | Derived | 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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |