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Baby steps against diabetes: early lifestyle intervention may shield High-Risk infants

NCT ID NCT06670625

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether intensive diet and physical activity counseling from 3 months to 2 years of age can protect the pancreas in infants with a genetic risk for Type 1 diabetes. About 1,244 babies will be randomly assigned to receive the counseling or standard care, and researchers will track growth, autoantibodies, and diabetes development up to age 6. The goal is to see if a healthy early lifestyle can reduce the chance of developing the disease.

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

About 1,244 people

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

Started

Mar 2025

Expected to finish

Dec 2031

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

3 to 4 months

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: * The age of the infant at time of enrolment should be 3.0 months (13 - 17 weeks). * An increased genetic risk (7-10%) to develop beta-cell autoantibodies by the age of 6 years. Genetic inclusion criteria: Children without a T1D-FDR having HLA DR3/DR4-DQ8, DR4-DQ8/DR4-DQ8 or DR4-DQ8/DR4-DQ7 rs6901541 C/T genotype and: * for males having a genetic risk score greater than or equal to 18.2 but excluding those who are eligible for AVANT1A. * for females having a genetic risk score greater than or equal to 14.5 but excluding those who are eligible for AVANT1A. Children with a T1D-FDR, all DR3/3, DR4-DQ8/DR4-DQ7 and DR4-DQ8/x where x is none of the following protective alleles: DRB1\*1501, DQB1\*0503, DRB1\*1303 will be included regardless of genetic risk score. \- Written informed consent signed by the custodial parent(s). Exclusion Criteria: * Any medical condition, concomitant disease or treatment that may interfere with the assessments or may jeopardize the participant's safe participation in the study, as judged by the investigators. * Preterm delivery \< 36 weeks of gestation. * Any condition that could be associated with poor compliance. * Diagnosis of diabetes prior to recruitment or randomization. * Current use of any investigational drug.

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus prevention target

As listed by the trial registrant

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

Autoimmune diabetes 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

    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

  • Clinical Research Center (CRC), Bldng 60:11

    RECRUITING

    Malmö, 20502, Sweden

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