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Completed

NCT Number: NCT05442398

Celiac Disease and 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

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of medicine Assiut university

Asyut, 71511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mohamed Salah Ahmed Ali

Other

Registry information

Official study title

Detection of Celiac Disease Among Suspected Patients With Type 1 Diabetes Mellitus

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 5, 2022
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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