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Could gut bacteria hold the key to better type 1 diabetes care?

NCT ID NCT05414409

Knowledge-focused Sponsor: Heba M. Ismail Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 21, 2026 · Last updated Aug 21, 2026

Summary

This study looks at gut bacteria in young people (ages 11-18) with type 1 diabetes, comparing those who are lean to those who are overweight or obese. Researchers want to see if differences in the microbiome relate to diabetes control and beta cell health. They will also test whether taking metformin for six months changes gut bacteria and related metabolites in overweight participants. The goal is to understand how the microbiome might influence diabetes and whether metformin could offer new benefits.

What this could mean

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

Active substance
Metformin, an oral medication that improves insulin sensitivity
What this could lead to
If successful, this could reveal how gut bacteria influence type 1 diabetes and whether metformin can improve health outcomes in overweight youth.
What could go wrong
This is an early-stage study focused on understanding mechanisms, not proving treatment benefits. Results may not lead to immediate clinical changes.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 114 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Mar 2027

An estimate. End dates often move.

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

11 to 18 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: 1. Overweight/obese youth 11-18 years of age with T1D at time of enrollment. 2. Lean youth 11-18 years of age with T1D at time of enrollment. Exclusion Criteria: 1. Known monogenic forms of diabetes or Type 2 diabetes (confirmed clinically and by genetic/antibody testing). 2. History of ongoing infection or antibiotic treatment within the past month; 3. History of immune-compromise, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past 6 months. 4. History of chronic gastrointestinal disease and active within the past 6 months, possible or confirmed celiac disease. 5. Participation in any research intervention trials within the past 3 months. 6. History of treatment or use of metformin, a type 2 diabetes medication.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder type 1 diabetes mellitus

As listed by the trial registrant

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

Obesity Type 1 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Indiana University School of Medicine

    RECRUITING

    Indianapolis, Indiana, 46202, United States

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