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Cornstarch timing may be key for rare sugar disorder

NCT ID NCT07645898

Knowledge-focused Sponsor: Federico II University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study looks at whether taking raw cornstarch with meals helps control blood sugar in adults with glycogen storage disease type I (GSD I). Eight participants will wear continuous glucose monitors and keep food diaries for two weeks. Researchers will compare blood sugar patterns after meals with and without cornstarch. The goal is to better understand how to time cornstarch intake to prevent low blood sugar and improve daily management.

What this could mean

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

Active substance
raw cornstarch
What this could lead to
If it works, this could help personalize dietary advice for people with GSD I, improving blood sugar control and reducing dangerous low blood sugar episodes.
What could go wrong
This is a very small observational study (only 8 people) with no control group, so results may not apply to everyone. It is not testing a new drug or treatment.

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.

Participants

About 8 people

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

Started

Feb 2026

Expected to finish

Feb 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.

Who is studied

Adult patients with genetically confirmed Glycogen Storage Disease type Ia or Ib routinely followed at the Unit of Diabetology of the University Hospital

Ages

18 years and older

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: * confirmed genetic diagnosis of GSD Ia or Ib; * age \>18 years; * routine CGM use; * habitual raw cornstarch consumption. Exclusion Criteria: * psychiatric disorders; * pregnancy, celiac disease; * dialysis treatment; * nocturnal enteral feeding; * severe acute or chronic illnesses.

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Conditions

The condition(s) this trial relates to.

glycogen storage disease I

As listed by the trial registrant

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

Glycogen storage disease type I

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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Policlinico "Federico II"

    RECRUITING

    Naples, Napoli, 80131, Italy

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