Prematurity Prevalence Among T1D Patients and Its Characteristics Compared With Premature-born Non-diabetic Patients

Type 1 Diabetes Mellitus Clinical Trial

— T1Dpremies  

Official title:

Prevalence of Premature Birth History Among Type 1 Diabetes Mellitus (T1D) Patients and Characteristics of Premature Born Children Who Develop T1D Compared With Those Who do Not

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929953
• Other study ID #: 183/13
• Status: Completed
• Start date: January 2014
• Est. completion date: April 2019

Study information

• Verified date: August 2019
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aims of this study are:

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3600
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 25 Years

Eligibility

Inclusion Criteria:

1. Patients diagnosed with T1D

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:

1. Lack of birth data

2. Unknown type of diabetes

3. For case control portion, an incomplete medical record/inadequate documentation

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Premature Birth
• Type 1 Diabetes Mellitus

Intervention

Other:
• chart review
data from charts and from registries will be compared

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center	Zerifin

Sponsors (12)

Lead Sponsor	Collaborator
Assaf Harofeh MC	Hadassah Medical Organization, HaEmek Medical Center, Israel, Kaplan Medical Center, Maccabi Healthcare Services, Israel, Rambam Health Care Campus, Schneider Children's Medical Center, Israel, Shaare Zedek Medical Center, Soroka University Medical Center, Tel-Aviv Sourasky Medical Center, Wolfson Medical Center, Ziv Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (21)

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. — View Citation

Arboleya S, Sánchez B, Milani C, Duranti S, Solís G, Fernández N, de los Reyes-Gavilán 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. Erratum in: Front Pediatr. 2015;3:60. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Kemppainen KM, Ardissone AN, Davis-Richardson AG, Fagen JR, Gano KA, León-Novelo LG, Vehik K, Casella G, Simell O, Ziegler AG, Rewers MJ, Lernmark Å, 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. — View Citation

Kostic AD, Gevers D, Siljander H, Vatanen T, Hyötyläinen T, Hämäläinen AM, Peet A, Tillmann V, Pöhö P, Mattila I, Lähdesmäki H, Franzosa EA, Vaarala O, de Goffau M, Harmsen H, Ilonen J, Virtanen SM, Clish CB, Orešic 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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Soll RF, Edwards WH. Antibiotic use in neonatal intensive care. Pediatrics. 2015 May;135(5):928-9. doi: 10.1542/peds.2015-0707. — View Citation

Uusitalo U, Liu X, Yang J, Aronsson CA, Hummel S, Butterworth M, Lernmark Å, 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Medications exposure in 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 and type of drugs initiation	1 years