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Time-Restricted eating may cut gestational diabetes risk in High-Risk pregnancies

NCT ID NCT06431997

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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 Results may not be published yet.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
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Expanded access (paused)
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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

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First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times

Summary

This study tests whether limiting eating to a 10-hour window each day can lower the chance of developing gestational diabetes in pregnant women at high risk. Researchers will compare this approach to usual eating habits over 3 months in 240 women. The goal is to see if this simple dietary change can prevent diabetes and improve outcomes for both mother and baby.

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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

240 people

The number who actually took part.

Started

Apr 2024

Finished

Jul 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 50 years

Sex

Female participants only

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. Aged 18-50 years; 2. The risk for GDM includes overweight or obesity (BMI ≥ 28 kg/m2 before pregnancy), first-degree relative with diabetes, history of cardiovascular disease, hypertension (≥130/80 mmHg or on therapy for hypertension), HDL cholesterol level \< 1 mmol/L and/or a triglyceride level \> 2.8 mmol/L, history of GDM, history of macrosomia delivery, individuals with polycystic ovary syndrome, repeated positive fasting urine glucose in the first trimester, or age\>45 years according to Guideline of Diagnosis and Treatment of Hyperglycemia in Pregnancy (2022); 3. Less than 14 weeks of gestation; 4. Able to read and complete questionnaires in Chinese; 5. singleton pregnancy. Exclusion criteria: 1. Pregestational diabetes (including diabetes diagnosed before conception; fasting blood glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5% in the first trimester; typical symptoms of hyperglycemia or hyperglycemic crisis with optional blood glucose ≥ 11.1 mmol/L); 2. Impaired glucose tolerance (including fasting blood glucose ≥ 5.6 mmol/L or two fasting blood glucose ≥ 5.1 mmol/L in the first trimester); 3. Current or recent use of drugs that affect glucose metabolism such as metformin, glucocorticoids and Orlistat; 4. Severe comorbidities (including cardiac diseases, kidney diseases, hepatopathy, autoimmune diseases, uncontrolled thyroid disease, previous or current malignant tumors, etc.); 5. Fetal malformations or chromosomal abnormalities; 6. Cervical insufficiency (including ultrasonic cervical length \< 25 mm before 24 weeks of gestation, history of spontaneous preterm birth at 14-36 weeks of previous pregnancy, or cervical dilation in the past or current pregnancy); 7. Exercise contraindications (including continuous vaginal bleeding, threatened premature labor, placenta previa, premature rupture of membranes, severe anemia, etc.); 8. Drug abuse, which refers to the repetitive, heavy use of drugs with dependent characteristics such as narcotic, psychotropic substances, tobacco and alcohol; 9. Hyperemesis gravidarum, which refers to the severe and persistent nausea and vomiting, unable to eat or eat little that leads to dehydration, ketosis and even acidosis; 10. On a special or prescribed diet for other reasons; 11. Eating window\<10 h; 12. Considered by the researchers to be ineligible for participation. Exit criteria: 1. Failure to comply with or assume the corresponding responsibilities and obligations of the informed agreement; 2. Pregnant women who terminate their pregnancy before completing GDM diagnosis and screening at 24-28 weeks of pregnancy will automatically withdraw from the group, such as severe fetal malformation, eclampsia, abortion, etc. 3. Major diseases, such as particularly serious obstetric medical events, malignant tumors, serious cardiovascular and cerebrovascular diseases, brain injuries, paralysis and other major diseases, can not continue to accept this intervention plan and follow-up, and withdraw from the study; 4. Accidental disability or death caused by non-intervention factors occurred during the study period, and he withdrew from the study; 5. Subjects are subjectively unwilling to continue to accept the intervention program, and sign the withdrawal agreement to withdraw from the group on a voluntary basis, and decide whether to continue to follow up the pregnancy process and outcome according to the specific contents of the withdrawal statement.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Obstetrics and Gynecology Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200011, China

More trials for these conditions

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