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Celiac Disease and Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05442398
Recruitment Status : Active, not recruiting
First Posted : July 5, 2022
Last Update Posted : August 2, 2022
Information provided by (Responsible Party):
Mohamed Salah Ahmed Ali, Assiut University

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

Condition or disease
Celiac Disease in Children

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 41 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Detection of Celiac Disease Among Suspected Patients With Type 1 Diabetes Mellitus
Actual Study Start Date : July 1, 2022
Estimated Primary Completion Date : January 15, 2023
Estimated Study Completion Date : February 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Primary Outcome Measures :
  1. Anti-tissue transglutaminase (anti-tTG) antibodies IgA-IgG [ Time Frame: within 2 weeks ]
    negative less than 10 positive if more than 10

  2. Total IGA [ Time Frame: within 2 weeks ]
    normal range 61-348

  3. HbA1c [ Time Frame: 1 day visit ]
    Less than 5.7% Pre-diabetes: 5.7% to 6.4% Diabetes: 6.5% or higher

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05442398

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Faculty of medicine Assiut university
Assiut, Egypt, 71511
Sponsors and Collaborators
Mohamed Salah Ahmed Ali
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Study Chair: Mostafa Tawfeek, Professor Assiut University

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Responsible Party: Mohamed Salah Ahmed Ali, Physician, Assiut University
ClinicalTrials.gov Identifier: NCT05442398    
Other Study ID Numbers: celiac and diabetes
First Posted: July 5, 2022    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Celiac Disease
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases