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

NCT06900946 | Enrolling By Invitation DMC

• 1 other identifier: 43012148
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 IgA antibodies to rule out celiac disease, as well as IgE antibody testing to exclude wheat allergy. After ruling out celiac disease, wheat allergy, and irritable bowel syndrome (IBS) using the Rome IV criteria, the patients will be invited to the clinic. The study's objectives, methods, and procedures will be explained, and written informed consent will be obtained from patients who are willing to participate. At the start of the study, each patient's weight will be measured while wearing light clothing using a mechanical scale (with an accuracy of 100 grams), and height will be measured without shoes using a wall-mounted meter (with an accuracy of 0.5 cm). The body mass index (BMI) of the patients will then be calculated. Additionally, general patient information will be recorded on the data collection form, and the gastrointestinal symptoms questionnaire (NCGS-SQ) will be completed. Next, blood sample will be drawn from the patients after fasting for 8 to 12 hours, and their serum will be collected to measure glycemic indices, including FBS, HbA1c, insulin, and HOMA-IR. A gluten-free diet (GFD) will be designed by a nutritionist to maintain the weight of type 2 diabetic patients and must be followed for 6 weeks. Carbohydrate distribution and diabetes-related recommendations will also be provided for the patients. Patient follow-up will be conducted via phone calls to ensure adherence to the diet and to prevent sample loss. Diet compliance will be assessed by a nutritionist, who will review the intake of any gluten-containing foods. After six weeks (Phase 1), glycemic indices will be re-evaluated through blood tests. Patients who have adhered to the diet optimally and experienced significant improvement in gastrointestinal symptoms will be suspected of having NCGS. If they agree, they will remain in the study and participate in a double-blind, placebo-controlled randomized trial. Those who do not show improvement in gastrointestinal symptoms during the first six weeks will be excluded from the study. In Phase 2, both the patients and the researchers assessing them will be blinded to the treatment being studied. Intervention group (gluten group) will receive 3 grams of gluten, and control group (placebo group) will receive 3 grams of corn starch powder, to be consumed daily mixed with milk or another beverage. Patients in both groups will continue following their gluten-free diets. At the end of study , glycemic indices will be re-evaluated, and changes in those indices over the 6-week period will be assessed. Additionally, a clinical symptoms questionnaire will be completed via phone calls every three weeks.

Conditions

Type 2 Diabetes; Non Celiac Gluten Sensitivity

Keywords

Type 2 Diabetes; T2DM; NCGS; Non celiac gluten sensitivity; Gluten free diet; GFD

Outcome Measures

Primary Outcomes (4)

• Glycated Hemoglobin (HbA1c)

  HbA1C change from baseline

  Initially, week 6, and week 12

• Fasting Blood Sugar (FBS)

  Blood sugar change from baseline

  Initially, week 6, and week 12

• Insulin

  blood insulin change from baseline

  Initially, week 6, and week 12

• Clinical symptoms

  changes in GI clinical symptoms from baseline according to visual analogue score of 0-10

  Initially, week 3, week 6, week 9, and week 12

Secondary Outcomes (17)

• HOMA-IR

  Initially, Week 6, and Week 12

• Abdominal pain or discomfort

  Initially, Week 3, Week 6, Week 9, and Week 12

• Heartburn

  Initially, Week 3, Week 6, Week 9, and Week 12

• Acid reflux

  Initially, Week 3, Week 6, Week 9, and Week 12

• Nausea and vomiting

  Initially, Week 3, Week 6, Week 9, and Week 12

Study Arms (2)

Intervention

ACTIVE COMPARATOR

3 grams of gluten powder taken daily

Other: gluten

Control

PLACEBO COMPARATOR

3 grams of corn starch powder taken daily

Other: cornstarch

Interventions

gluten OTHER

The intervention group will receive 3 grams of gluten powder daily

Intervention

cornstarch OTHER

The control group will receive 3 grams of cornstarch powder daily

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Nutrition and Food Technology Institute: lead

Study Sites (1)

Behboud Clinic

Tehran, Tehran Province, 19437, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Glutens; Starch

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Prolamins; Grain Proteins; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Seed Storage Proteins; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 28, 2025
• Study Start: April 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

IR (1)