Celiac Disease and Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT05442398|
Recruitment Status : Active, not recruiting
First Posted : July 5, 2022
Last Update Posted : August 2, 2022
|Condition or disease|
|Celiac Disease in Children|
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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||41 participants|
|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|
- 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
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
|Faculty of medicine Assiut university|
|Assiut, Egypt, 71511|
|Study Chair:||Mostafa Tawfeek, Professor||Assiut University|