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New study tests lifestyle program to stop gestational diabetes before it starts

NCT ID NCT06445270

Prevention Sponsor: Indiana University 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Updated 2 times

Summary

This study tests whether a more intensive diet and activity counseling program can help high-risk pregnant women keep their blood sugar in a healthy range and lower their chances of developing gestational diabetes. About 100 women early in pregnancy (16 weeks or less) who have risk factors like age 35+, family history of diabetes, or high BMI will take part. The program will be compared to the standard diet and activity advice usually given.

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.

Expected to start

Aug 2026

An estimate. Start dates often move.

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

14 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Gestational age less or equal to 16 + 6 weeks confirmed via ACOG dating guidelines AND one of the following * 35 years of age or older * Family history of first degree relative with diabetes mellitus * Body Mass Index (BMI) greater than or equal to 30 * Hemoglobin A1c value between 5.9% to 6.4% Exclusion Criteria: * Multiple gestations * Current diagnosis of Type 1 or 2 diabetes mellitus including a diagnosis during this pregnancy * Pre-pregnancy chronic (\>2 weeks) usage of systemic steroids (inhaled and short term usage acceptable) * Planned pregnancy termination * Currently taking or took 3 months prior to conception Metformin * Unable to provide informed consent in English or Spanish * Major fetal anomalies listed below that are known prior to enrollment. Major fetal anomalies: * Congenital diaphragmatic hernia * Congenital cystic adenomatoid malformation * Pleural effustions * Chylothorax * Bronchogenic cyst * Bronchopulmonary sequestration * Anomalous pulmonary venous return * Tricuspid atresia * Mitral atresia * Double right ventricle * Ebstein's malformation * Pulmonary atresia * Hypoplastic left heart syndrome * Aortic coarctation * Fetal arrhythmias * Transposition of the great vessels * Tetrology of Fallot * Double outlet right ventricle * Aortic stenosis * Holoprosencephaly * Anencephaly * Dandy-Walker malformation or variant * Septo-optic dysplasia * Neural tube defect * Vein of Galen aneurysm * Bilateral renal agenesis * Cystic renal disease * Obstructive uropathy * Horseshoe kidney * Megacystis microcolon * Cloacal abnormality * Achondrogenesis * Thanatophoric dysplasia * Thoracic dysplasia * Osteogenesis imperfecta * Short rib polydacyly * Any skeletal defect with suspected small thorax * Hypophosphatemia * Any karyotypic abnormality * Any suspected genetic syndrome * Cleft lip/palate * Micrognathia * Hydrops * Fetal anemia (\<35% on cordocentesis) * Neck mass * Gastroschsis * Omphalocele

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Conditions

The condition(s) this trial relates to.

gestational diabetes pregnancy disorder

As listed by the trial registrant

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

Gestational diabetes Pregnancy complications

Contacts and locations

Locations

  • Sidney and Lois Eskenazi Hospital

    Indianapolis, Indiana, 46202, United States

More trials for these conditions

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