Celiac Disease and Diabetes Mellitus

NCT05442398 | Completed

• 1 other identifier: celiac and diabetes
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to detect Celiac Disease among suspected patients with Type 1 Diabetes Mellitus who admitted to Assiut University Children's Hospital during one year duration

Conditions

Celiac Disease in Children

Outcome Measures

Primary Outcomes (3)

• Anti-tissue transglutaminase (anti-tTG) antibodies IgA-IgG

  negative less than 10 positive if more than 10

  within 2 weeks

• Total IGA

  normal range 61-348

  within 2 weeks

• HbA1c

  Less than 5.7% Pre-diabetes: 5.7% to 6.4% Diabetes: 6.5% or higher

  1 day visit

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Sample size was calculated using Epi- Info7. There was no previous studies that calculate the percentage of Children from 1-18 years old diagnosed as Type 1 Diabetes mellitus with Symptoms and signs suggestive of Celiac disease, we hypothesized that the percentage will be 50% . Based on this percentage and with a confidence limits of 10% and a confidence level of 80%, the minimum sample needed for the study was estimated to be 41 patients.

You may qualify if:

• Type 1 Diabetes mellitus
• Symptoms and signs suggestive of Celiac disease.
• Age : 1-18 years old

You may not qualify if:

• No symptoms or signs suggestive of celiac disease.
• Patients who are Non CD gluten hypersensitivity
• Age : less than 1 year old.

Sponsors & Collaborators

• Mohamed Salah Ahmed Ali: lead

Study Sites (1)

Faculty of medicine Assiut university

Asyut, 71511, Egypt

Location

Related Publications (12)

• Volta U, Tovoli F, Caio G. Clinical and immunological features of celiac disease in patients with Type 1 diabetes mellitus. Expert Rev Gastroenterol Hepatol. 2011 Aug;5(4):479-87. doi: 10.1586/egh.11.38.

  PMID: 21780895 BACKGROUND

• Scaramuzza AE, Mantegazza C, Bosetti A, Zuccotti GV. Type 1 diabetes and celiac disease: The effects of gluten free diet on metabolic control. World J Diabetes. 2013 Aug 15;4(4):130-4. doi: 10.4239/wjd.v4.i4.130.

  PMID: 23961323 BACKGROUND

• Husby S, Koletzko S, Korponay-Szabo I, Kurppa K, Mearin ML, Ribes-Koninckx C, Shamir R, Troncone R, Auricchio R, Castillejo G, Christensen R, Dolinsek J, Gillett P, Hrobjartsson A, Koltai T, Maki M, Nielsen SM, Popp A, Stordal K, Werkstetter K, Wessels M. European Society Paediatric Gastroenterology, Hepatology and Nutrition Guidelines for Diagnosing Coeliac Disease 2020. J Pediatr Gastroenterol Nutr. 2020 Jan;70(1):141-156. doi: 10.1097/MPG.0000000000002497.

  PMID: 31568151 BACKGROUND

• Fasano A, Catassi C. Clinical practice. Celiac disease. N Engl J Med. 2012 Dec 20;367(25):2419-26. doi: 10.1056/NEJMcp1113994. No abstract available.

  PMID: 23252527 BACKGROUND

• Green PH, Cellier C. Celiac disease. N Engl J Med. 2007 Oct 25;357(17):1731-43. doi: 10.1056/NEJMra071600. No abstract available.

  PMID: 17960014 BACKGROUND

• Chiang JL, Maahs DM, Garvey KC, Hood KK, Laffel LM, Weinzimer SA, Wolfsdorf JI, Schatz D. Type 1 Diabetes in Children and Adolescents: A Position Statement by the American Diabetes Association. Diabetes Care. 2018 Sep;41(9):2026-2044. doi: 10.2337/dci18-0023. Epub 2018 Aug 9. No abstract available.

  PMID: 30093549 BACKGROUND

• Jabri B, Kasarda DD, Green PH. Innate and adaptive immunity: the yin and yang of celiac disease. Immunol Rev. 2005 Aug;206:219-31. doi: 10.1111/j.0105-2896.2005.00294.x.

  PMID: 16048552 BACKGROUND

• Mahmud FH, Elbarbary NS, Frohlich-Reiterer E, Holl RW, Kordonouri O, Knip M, Simmons K, Craig ME. ISPAD Clinical Practice Consensus Guidelines 2018: Other complications and associated conditions in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2018 Oct;19 Suppl 27(Suppl 27):275-286. doi: 10.1111/pedi.12740. No abstract available.

  PMID: 30066458 BACKGROUND

• Iughetti L, Bulgarelli S, Forese S, Lorini R, Balli F, Bernasconi S. Endocrine aspects of coeliac disease. J Pediatr Endocrinol Metab. 2003 Jul-Aug;16(6):805-18. doi: 10.1515/jpem.2003.16.6.805.

  PMID: 12948292 BACKGROUND

• Ergur AT, Ocal G, Berberoglu M, Adiyaman P, Siklar Z, Aycan Z, Evliyaoglu O, Kansu A, Girgin N, Ensari A. Celiac disease and autoimmune thyroid disease in children with type 1 diabetes mellitus: clinical and HLA-genotyping results. J Clin Res Pediatr Endocrinol. 2010;2(4):151-4. doi: 10.4274/jcrpe.v2i4.151. Epub 2010 Nov 3.

  PMID: 21274314 BACKGROUND

• Odeh R, Alassaf A, Gharaibeh L, Ibrahim S, Khdair Ahmad F, Ajlouni K. Prevalence of celiac disease and celiac-related antibody status in pediatric patients with type 1 diabetes in Jordan. Endocr Connect. 2019 Jun 13;8(6):780-787. doi: 10.1530/EC-19-0146.

  PMID: 31085767 BACKGROUND

• Unal E, Demiral M, Baysal B, Agin M, Devecioglu EG, Demirbilek H, Ozbek MN. Frequency of Celiac Disease and Spontaneous Normalization Rate of Celiac Serology in Children and Adolescent Patients with Type 1 Diabetes. J Clin Res Pediatr Endocrinol. 2021 Feb 26;13(1):72-79. doi: 10.4274/jcrpe.galenos.2020.2020.0108. Epub 2020 Aug 21.

  PMID: 32820875 BACKGROUND

Study Officials

• Mostafa Tawfeek, Professor

  Assiut University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 5, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: August 2, 2024
• Last Updated: August 5, 2024

Record last verified: 2024-08

Locations

EG (1)