Evaluation of the Effects of Gluten Free Diet on Clinical Symptoms and Glycemic Index in Type 2 Diabetic Patients with Non-celiac Gluten Sensitivity

Launched by NATIONAL NUTRITION AND FOOD TECHNOLOGY INSTITUTE · Mar 22, 2025

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ClinConnect Summary

This clinical trial is looking at how a gluten-free diet may affect the symptoms and blood sugar levels in people with type 2 diabetes who have non-celiac gluten sensitivity (NCGS). If you have type 2 diabetes and experience stomach issues but do not have celiac disease or a wheat allergy, you might be eligible to participate. To join, you should not have followed any specific diets in the last six months, and you should be willing to stick to a gluten-free diet throughout the study.

During the trial, participants will first have their weight, height, and blood sugar levels checked. They will then follow a gluten-free diet designed by a nutritionist for six weeks. Researchers will call to check in and make sure participants are sticking to the diet. After six weeks, those who feel better and show improvement in their blood sugar levels may continue into the next phase of the study, where they will receive either gluten or a placebo, without knowing which one they are getting. This will help determine if gluten is affecting their symptoms. Overall, this study aims to better understand the link between diet and diabetes management for those with NCGS.

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • Inability or unwillingness to continue with the study
• • Pregnancy or Lactation
• • Occurrence of any side effects