Type 2 DiabetesNCT06900946
Evaluation of the Effects of Gluten Free Diet on Clinical Symptoms and Glycemic Index in Type 2 Diabetic Patients With Non-celiac Gluten Sensitivity
A study testing gluten and cornstarch in people with Type 2 Diabetes and Non Celiac Gluten Sensitivity, run by National Nutrition and Food Technology Institute at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes, Non Celiac Gluten Sensitivity
- What is being tested?
- gluten and cornstarch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- 1 Mar 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability or unwillingness to continue with the study
- Pregnancy or Lactation
- Occurrence of any side effects
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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 1 grams of gluten, and control group (placebo group) will receive 1 grams of corn starch powder, to be consumed daily. 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
- Being tested
- gluten, cornstarch
- Keywords
- Type 2 Diabetes, T2DM, NCGS, Non celiac gluten sensitivity, Gluten free diet, GFD
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glutenOther
The intervention group will receive 1 gram of gluten powder daily
cornstarchOther
The control group will receive 1 gram of cornstarch powder daily
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | 1 gram of gluten powder taken daily Receives: Other: gluten |
| Control | Placebo comparator | 1 gram of corn starch powder taken daily Receives: Other: cornstarch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Hemoglobin (HbA1c)
HbA1C change from baseline
Measured: Initially, week 6, and week 12
Fasting Blood Sugar (FBS)
Blood sugar change from baseline
Measured: Initially, week 6, and week 12
Insulin
blood insulin change from baseline
Measured: Initially, week 6, and week 12
Clinical symptoms
changes in GI clinical symptoms from baseline according to visual analogue score of 0-10
Measured: Initially, week 3, week 6, week 9, and week 12
Secondary outcomes (17)
HOMA-IR
HOMA-IR change from the baseline
Measured: Initially, Week 6, and Week 12
Abdominal pain or discomfort
changes in abdominal pain from baseline according to visual analogue score of 0-10
Measured: Initially, Week 3, Week 6, Week 9, and Week 12
Heartburn
changes in heart burn symptom from baseline according to visual analogue score of 0-10
Measured: Initially, Week 3, Week 6, Week 9, and Week 12
Acid reflux
changes in sense of acid reflux from baseline according to visual analogue score of 0-10
Measured: Initially, Week 3, Week 6, Week 9, and Week 12
Nausea and vomiting
changes in nausea and vomiting symptoms from baseline according to visual analogue score of 0-10
Measured: Initially, Week 3, Week 6, Week 9, and Week 12
Bloating
changes in bloating sense from baseline according to visual analogue score of 0-10
Measured: Initially, Week 3, Week 6, Week 9, and Week 12
Borborygmus (stomach rumbling)
changes in Borborygmus symptoms from baseline according to visual analogue score of 0-10
Measured: Initially, Week 3, Week 6, Week 9, and Week 12
Abdominal distension
changes in abdominal distension symptoms from baseline according to visual analogue score of 0-10
Measured: Initially, Week 3, Week 6, Week 9, and Week 12
Feeling of belching (burping)
changes in feeling of belching from baseline according to visual analogue score of 0-10
Measured: Initially, Week 3, Week 6, Week 9, and Week 12
flatulence
changes in flatulence symptom from baseline according to visual analogue score of 0-10
Measured: Initially, Week 3, Week 6, Week 9, and Week 12
Reduced stool passage
changes in feeling reduced stool passage from baseline according to visual analogue score of 0-10
Measured: Initially, Week 3, Week 6, Week 9, and Week 12
Increased stool passage
changes in feeling increased stool passage from baseline according to visual analogue score of 0-10
Measured: Initially, Week 3, Week 6, Week 9, and Week 12
Loose stools
changes in number of loose stools per day from baseline according to visual analogue score of 0-10
Measured: Initially, Week 3, Week 6, Week 9, and Week 12
Hard stools
changes in hard stools per day from baseline according to visual analogue score of 0-10
Measured: Initially, Week 3, Week 6, Week 9, and Week 12
Urgency to defecate
changes in frequency of urgency to defecate from baseline according to visual analogue score of 0-10
Measured: Initially, Week 3, Week 6, Week 9, and Week 12
Feeling of incomplete evacuation
changes in feeling of incomplete evacuation from baseline according to visual analogue score of 0-10
Measured: Initially, Week 3, Week 6, Week 9, and Week 12
Extraintestinal symptoms
changes in extra-intestinal symptoms from baseline according to visual analogue score of 0-10
Measured: Initially, Week 3, Week 6, Week 9, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Mar 2025
- Primary completion1 Apr 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900946
- Sponsor's protocol ID
- 43012148
- Status last verified
- Aug 2026
- First submitted
- 17 Mar 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Gluten Free Diet on Clinical Symptoms and Glycemic Index in Type 2 Diabetic Patients With Non-celiac Gluten Sensitivity
- ClinicalTrials.gov ID
- NCT06900946
- Acronym / sponsor ID
- 43012148
- Conditions
- Type 2 Diabetes, Non Celiac Gluten Sensitivity
- Keywords
- Type 2 Diabetes, T2DM, NCGS, Non celiac gluten sensitivity, Gluten free diet, GFD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 1 grams of gluten, and control group (placebo group) will receive 1 grams of corn starch powder, to be consumed daily. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: gluten1 gram of gluten powder taken daily |
| Control | Placebo comparator | Other: cornstarch1 gram of corn starch powder taken daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Inability or unwillingness to continue with the study
- Pregnancy or Lactation
- Occurrence of any side effects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glutenThe intervention group will receive 1 gram of gluten powder daily | Other | Intervention |
| cornstarchThe control group will receive 1 gram of cornstarch powder daily | Other | Control |
Primary outcome
Glycated Hemoglobin (HbA1c)
Time frame: Initially, week 6, and week 12
HbA1C change from baseline
Fasting Blood Sugar (FBS)
Time frame: Initially, week 6, and week 12
Blood sugar change from baseline
Insulin
Time frame: Initially, week 6, and week 12
blood insulin change from baseline
Clinical symptoms
Time frame: Initially, week 3, week 6, week 9, and week 12
changes in GI clinical symptoms from baseline according to visual analogue score of 0-10
17 secondary outcomes
HOMA-IR
Time frame: Initially, Week 6, and Week 12
Abdominal pain or discomfort
Time frame: Initially, Week 3, Week 6, Week 9, and Week 12
Heartburn
Time frame: Initially, Week 3, Week 6, Week 9, and Week 12
Acid reflux
Time frame: Initially, Week 3, Week 6, Week 9, and Week 12
Nausea and vomiting
Time frame: Initially, Week 3, Week 6, Week 9, and Week 12
Bloating
Time frame: Initially, Week 3, Week 6, Week 9, and Week 12
Borborygmus (stomach rumbling)
Time frame: Initially, Week 3, Week 6, Week 9, and Week 12
Abdominal distension
Time frame: Initially, Week 3, Week 6, Week 9, and Week 12
Feeling of belching (burping)
Time frame: Initially, Week 3, Week 6, Week 9, and Week 12
flatulence
Time frame: Initially, Week 3, Week 6, Week 9, and Week 12
Reduced stool passage
Time frame: Initially, Week 3, Week 6, Week 9, and Week 12
Increased stool passage
Time frame: Initially, Week 3, Week 6, Week 9, and Week 12
Loose stools
Time frame: Initially, Week 3, Week 6, Week 9, and Week 12
Hard stools
Time frame: Initially, Week 3, Week 6, Week 9, and Week 12
Urgency to defecate
Time frame: Initially, Week 3, Week 6, Week 9, and Week 12
Feeling of incomplete evacuation
Time frame: Initially, Week 3, Week 6, Week 9, and Week 12
Extraintestinal symptoms
Time frame: Initially, Week 3, Week 6, Week 9, and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gluten and cornstarch in people with Type 2 Diabetes and Non Celiac Gluten Sensitivity, run by National Nutrition and Food Technology Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated Hemoglobin (HbA1c) (time frame: Initially, week 6, and week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.