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Celiac Disease and Diabetes Mellitus

Sponsor
Mohamed Salah Ahmed Ali (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05442398
Collaborator
(none)
41
Enrollment
1
Location
7.5
Anticipated Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    41 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Detection of Celiac Disease Among Suspected Patients With Type 1 Diabetes Mellitus
    Actual Study Start Date :
    Jul 1, 2022
    Anticipated Primary Completion Date :
    Jan 15, 2023
    Anticipated Study Completion Date :
    Feb 15, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Anti-tissue transglutaminase (anti-tTG) antibodies IgA-IgG [within 2 weeks]

      negative less than 10 positive if more than 10

    2. Total IGA [within 2 weeks]

      normal range 61-348

    3. HbA1c [1 day visit]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of medicine Assiut university Assiut Egypt 71511

    Sponsors and Collaborators

    • Mohamed Salah Ahmed Ali

    Investigators

    • Study Chair: Mostafa Tawfeek, Professor, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mohamed Salah Ahmed Ali, Physician, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05442398
    Other Study ID Numbers:
    • celiac and diabetes
    First Posted:
    Jul 5, 2022
    Last Update Posted:
    Aug 2, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Celiac Disease
    Diabetes Mellitus

    Study Results

    No Results Posted as of Aug 2, 2022