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Could dropping gluten tame blood sugar and gut woes in diabetes?

NCT ID NCT06900946

Disease control Sponsor: National Nutrition and Food Technology Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial explores whether a gluten-free diet can ease digestive symptoms and improve blood sugar control in people with type 2 diabetes who have non-celiac gluten sensitivity. Participants first follow a gluten-free diet for six weeks. Those who feel better then take part in a blinded phase where they receive either gluten powder or a placebo (cornstarch) daily, while continuing the diet, to see if symptoms and blood sugar markers change.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
gluten-free diet followed by a gluten challenge (gluten powder) versus placebo (cornstarch powder)
What this could lead to
If it works, this could point toward a dietary approach to help manage blood sugar and gut discomfort in people with type 2 diabetes who are sensitive to gluten.
What could go wrong
This is a small, early trial, and results may not apply to everyone. The gluten challenge could trigger symptoms, and the diet is hard to maintain long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

40 people

The number who actually took part.

Started

Mar 2025

Finished

Aug 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non celiac gluten sensitivity Type 2 diabetes

Contacts and locations

Locations

  • Behboud Clinic

    Tehran, 19437, Iran

More trials for these conditions

Other studies related to the condition(s) this trial covers.