Time-restricted eating for pregnant women at high risk of gestational diabetes

Effects of Time-restricted Eating on the Incidence of Gestational Diabetes Mellitus in High-risk Populations: a Randomized Controlled Study

This study is testing if eating within a 10-hour window can help pregnant women at high risk for gestational diabetes avoid developing the condition.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Fudan University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06431997 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial investigates the effects of time-restricted eating (TRE) on reducing the incidence of gestational diabetes mellitus (GDM) in high-risk pregnant women. A total of 240 women in early pregnancy will be randomly assigned to either a TRE group, where they will consume their prescribed calories within a 10-hour eating window, or a standard of care group, where they will follow their habitual eating schedule. Both groups will receive diet and exercise counseling and will be monitored for GDM diagnosis through a glucose tolerance test at 24-28 weeks of gestation. The study aims to assess whether TRE can effectively lower the risk of GDM compared to traditional eating patterns.

Who should consider this trial

Good fit: Ideal candidates for this study are pregnant women aged 18-50 years who are at high risk for gestational diabetes due to factors such as obesity, family history of diabetes, or previous gestational diabetes.

Not a fit: Patients who have pregestational diabetes or other significant metabolic disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of gestational diabetes in high-risk pregnant women, improving maternal and fetal health outcomes.

How similar studies have performed: While the concept of time-restricted eating is gaining attention, this specific application in high-risk pregnant populations is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion criteria:

1. Aged 18-50 years;
2. The risk for GDM includes overweight or obesity (BMI ≥ 24 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.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Obstetrics and Gynecology Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Ying Zhao, PhD

Conditions Gestational Diabetes Mellitus; Dietary Habits; Lifestyle Intervention; Randomized Controlled Study; Metabolic Diseases