Status:
ENROLLING_BY_INVITATION
Evaluation of the Effects of Gluten Free Diet on Clinical Symptoms and Glycemic Index in Type 2 Diabetic Patients With Non-celiac Gluten Sensitivity
Lead Sponsor:
National Nutrition and Food Technology Institute
Conditions:
Type 2 Diabetes
Non Celiac Gluten Sensitivity
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Confirmed cases of type 2 diabetes who have presented with gastrointestinal symptoms and have no diagnosed gastrointestinal diseases will be referred to the laboratory for testing of tTG IgA and total...
Eligibility Criteria
Inclusion
- Exclusion of Celiac Disease and Wheat Allergy (tTG IgA antibody test for celiac disease exclusion and IgE antibody test for ruling out wheat allergy)
- Exclusion of Irritable Bowel Syndrome (IBS) using the Rome IV diagnostic criteria by a gastroenterologist
- No adherence to any specific diet in the past 6 months, including the gluten-free diet (GFD)
- Willing and capable of following a gluten-free diet (GFD)
- No consumption of alcohol or drugs
- No use of corticosteroids or antidepressant medications
- No history of thyroid disorders, autoimmune diseases, cancer, or gastrointestinal diseases
Exclusion
- Inability or unwillingness to continue with the study
- Pregnancy or Lactation
- Occurrence of any side effects
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06900946
Start Date
April 1 2025
End Date
October 1 2025
Last Update
May 23 2025
Active Locations (1)
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1
Behboud Clinic
Tehran, Tehran Province, Iran, 19437