Celiac Disease in ChildrenNCT05442398
Celiac Disease and Diabetes Mellitus
An observational study of Celiac Disease in Children, run by Mohamed Salah Ahmed Ali at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Celiac Disease in Children
- How many people
- 41 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 2 Aug 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Type 1 Diabetes mellitus
- Symptoms and signs suggestive of Celiac disease.
- Age : 1-18 years old
Who cannot join
- No symptoms or signs suggestive of celiac disease.
- Patients who are Non CD gluten hypersensitivity
- Age : less than 1 year old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Celiac Disease Among Suspected Patients With Type 1 Diabetes Mellitus
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
Read the detailed description
Type 1 diabetes mellitus (T1DM) is an immune-mediated disease characterized by reduced insulin secretion by islet Beta cells in the pancreas that leads to insulin deficiency . Because of a common genetic background and interaction between environmental and immunological factors, Patients with T1DM are at a great risk for developing autoimmune diseases. It is well recognized that T1DM can be associated with celiac disease (CD) and autoimmune thyroid disorders (ATD). Recent studies regarding CD and T1DM have indicated that the frequency of this association can vary from 1.7% to 16% . Also other autoimmune diseases may be noted such as Addison's disease and vitiligo.
Celiac disease is an autoimmune enteropathy that is caused by permanent susceptibility to gluten (a protein found in wheat, barley, and rye) in genetically susceptible individuals .
CD develops with symptoms, such as steatorrhea, weight loss, developmental disorder, abdominal pain, and nutritional symptoms (e.g. vitamin deficiency), and is improved shortly after elimination of gluten-containing foods .
Extraintestinal signs and symptoms include iron-deficiency anemia, chronic fatigue, failure to thrive, stunted or short stature, delayed puberty, amenorrhea, recurrent aphthous stomatitis, dermatitis herpetiformis - like rash, fracture with inadequate traumas, osteopenia, osteoporosis.
Since the majority of CD patients can be asymptomatic, screening for CD at the time of T1DM diagnosis is recommended . In seronegative cases at the first screening, if there are no CD symptoms, regular screening every 2-5 years is recommended. However, in patients with CD symptoms or history of CD in first-degree relatives more frequent screening is recommended . Testing of asymptomatic CD would provide a prompt diagnosis of CD and enable better metabolic control for T1DM patients .
However, recently, some studies have shown normalization of celiac serology in patients with T1DM, even with no gluten-free dietary intervention. In the mentioned studies, spontaneous normalization developed in 20-35% of the cases
. Therefore, considering all of the serologically positive individuals as CD and giving a gluten-free diet (GFD) imposes an additional psychological burden for children and families.
In the latest European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) guidelines, it was highlighted that the level of anti-tissue transglutaminase-IgA (anti-TTG IgA) should be at least 10 times higher than the upper limit of normal (ULN) for diagnosis of CD without duodenal biopsy.
- Conditions
- Celiac Disease in Children
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-tissue transglutaminase (anti-tTG) antibodies IgA-IgG
negative less than 10 positive if more than 10
Measured: within 2 weeks
Total IGA
normal range 61-348
Measured: within 2 weeks
HbA1c
Less than 5.7% Pre-diabetes: 5.7% to 6.4% Diabetes: 6.5% or higher
Measured: 1 day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Jul 2022
- Primary completion31 Dec 2023
- Study completion2 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 41 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Mohamed Salah Ahmed Ali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Salah Ahmed Ali, Assiut University
- Investigators
- Mostafa Tawfeek, Professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442398
- Sponsor's protocol ID
- celiac and diabetes
- Status last verified
- Aug 2024
- First submitted
- 24 Jun 2022
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21780895Scaramuzza 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.
PubMed 23961323Husby 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.
PubMed 31568151Fasano 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.
PubMed 23252527Green PH, Cellier C. Celiac disease. N Engl J Med. 2007 Oct 25;357(17):1731-43. doi: 10.1056/NEJMra071600. No abstract available.
PubMed 17960014Chiang 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.
PubMed 30093549Jabri 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.
PubMed 16048552Mahmud 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.
PubMed 30066458Iughetti 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.
PubMed 12948292Ergur 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.
PubMed 21274314Odeh 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.
PubMed 31085767Unal 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.
PubMed 32820875
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Celiac Disease Among Suspected Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05442398
- Acronym / sponsor ID
- celiac and diabetes
- Conditions
- Celiac Disease in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Mohamed Salah Ahmed AliUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Type 1 diabetes mellitus (T1DM) is an immune-mediated disease characterized by reduced insulin secretion by islet Beta cells in the pancreas that leads to insulin deficiency . Because of a common genetic background and interaction between environmental and immunological factors, Patients with T1DM are at a great risk for developing autoimmune diseases. It is well recognized that T1DM can be associated with celiac disease (CD) and autoimmune thyroid disorders (ATD). Recent studies regarding CD and T1DM have indicated that the frequency of this association can vary from 1.7% to 16% . Also other autoimmune diseases may be noted such as Addison's disease and vitiligo.
Celiac disease is an autoimmune enteropathy that is caused by permanent susceptibility to gluten (a protein found in wheat, barley, and rye) in genetically susceptible individuals .
CD develops with symptoms, such as steatorrhea, weight loss, developmental disorder, abdominal pain, and nutritional symptoms (e.g. vitamin deficiency), and is improved shortly after elimination of gluten-containing foods .
Extraintestinal signs and symptoms include iron-deficiency anemia, chronic fatigue, failure to thrive, stunted or short stature, delayed puberty, amenorrhea, recurrent aphthous stomatitis, dermatitis herpetiformis - like rash, fracture with inadequate traumas, osteopenia, osteoporosis.
Since the majority of CD patients can be asymptomatic, screening for CD at the time of T1DM diagnosis is recommended . In seronegative cases at the first screening, if there are no CD symptoms, regular screening every 2-5 years is recommended. However, in patients with CD symptoms or history of CD in first-degree relatives more frequent screening is recommended . Testing of asymptomatic CD would provide a prompt diagnosis of CD and enable better metabolic control for T1DM patients .
However, recently, some studies have shown normalization of celiac serology in patients with T1DM, even with no gluten-free dietary intervention. In the mentioned studies, spontaneous normalization developed in 20-35% of the cases
. Therefore, considering all of the serologically positive individuals as CD and giving a gluten-free diet (GFD) imposes an additional psychological burden for children and families.
In the latest European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) guidelines, it was highlighted that the level of anti-tissue transglutaminase-IgA (anti-TTG IgA) should be at least 10 times higher than the upper limit of normal (ULN) for diagnosis of CD without duodenal biopsy.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Type 1 Diabetes mellitus
- Symptoms and signs suggestive of Celiac disease.
- Age : 1-18 years old
Key exclusion criteria (3 listed)
- No symptoms or signs suggestive of celiac disease.
- Patients who are Non CD gluten hypersensitivity
- Age : less than 1 year old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anti-tissue transglutaminase (anti-tTG) antibodies IgA-IgG
Time frame: within 2 weeks
negative less than 10 positive if more than 10
Total IGA
Time frame: within 2 weeks
normal range 61-348
HbA1c
Time frame: 1 day visit
Less than 5.7% Pre-diabetes: 5.7% to 6.4% Diabetes: 6.5% or higher
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Background: PubMed 21780895Volta 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.
- Background: PubMed 23961323Scaramuzza 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.
- Background: PubMed 31568151Husby 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.
- Background: PubMed 23252527Fasano 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.
- Background: PubMed 17960014Green PH, Cellier C. Celiac disease. N Engl J Med. 2007 Oct 25;357(17):1731-43. doi: 10.1056/NEJMra071600. No abstract available.
- Background: PubMed 30093549Chiang 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.
- Background: PubMed 16048552Jabri 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.
- Background: PubMed 30066458Mahmud 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.
- Background: PubMed 12948292Iughetti 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.
- Background: PubMed 21274314Ergur 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.
- Background: PubMed 31085767Odeh 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.
- Background: PubMed 32820875Unal 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mostafa Tawfeek, Professor study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease in Children, run by Mohamed Salah Ahmed Ali at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-tissue transglutaminase (anti-tTG) antibodies IgA-IgG (time frame: within 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05442398, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.