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New treatment option for Gestational Diabetes Mellitus
Official title A Study of the Intervention of Time-restricted Eating in High-risk Populations of GDM
ClinicalTrials.gov ID: NCT06431997
What this study is testing
- What it's testing
- This is a randomized controlled trial, aiming to investigate whether a time-restricted eating (TRE) can reduce the incidence of gestational diabetes mellitus (GDM) in high-risk pregnant women. Investigators intend to conduct a 3-month randomized controlled study to compare the effects of 10-hour TRE and habitual eating time on GDM .
- Time commitment: about 3 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join if
- Aged 18-50 years;
- The risk for GDM includes overweight or obesity (BMI ≥ 24 kg/m2 before pregnancy), first-degree relative with diabetes, history of cardiovascular...
- Less than 14 weeks of gestation;
- Able to read and complete questionnaires in Chinese;
- singleton pregnancy.
You likely can't join if
- Pregestational diabetes (including diabetes diagnosed before conception; fasting blood glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5% in the first trimester...
- Impaired glucose tolerance (including fasting blood glucose ≥ 5.6 mmol/L or two fasting blood glucose ≥ 5.1 mmol/L in the first trimester);
- Current or recent use of drugs that affect glucose metabolism such as metformin, glucocorticoids and Orlistat;
- Severe comorbidities (including cardiac diseases, kidney diseases, hepatopathy, autoimmune diseases, uncontrolled thyroid disease, previous or...
- Fetal malformations or chromosomal abnormalities;
- Cervical insufficiency (including ultrasonic cervical length \< 25 mm before 24 weeks of gestation, history of spontaneous preterm birth at 14-36...
See the full eligibility criteria
- Aged 18-50 years;
- 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...
- Less than 14 weeks of gestation;
- Able to read and complete questionnaires in Chinese;
- singleton pregnancy.
- 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...
- Impaired glucose tolerance (including fasting blood glucose ≥ 5.6 mmol/L or two fasting blood glucose ≥ 5.1 mmol/L in the first trimester);
- Current or recent use of drugs that affect glucose metabolism such as metformin, glucocorticoids and Orlistat;
- Severe comorbidities (including cardiac diseases, kidney diseases, hepatopathy, autoimmune diseases, uncontrolled thyroid disease, previous or current malignant tumors, etc.);
- Fetal malformations or chromosomal abnormalities;
- 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...
- Exercise contraindications (including continuous vaginal bleeding, threatened premature labor, placenta previa, premature rupture of membranes, severe anemia, etc.);
- Drug abuse, which refers to the repetitive, heavy use of drugs with dependent characteristics such as narcotic, psychotropic substances, tobacco and alcohol;
- 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;
- On a special or prescribed diet for other reasons;
- Eating window\<10 h. Exit criteria：
- Failure to comply with or assume the corresponding responsibilities and obligations of the informed agreement;
- 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...
- 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...
- Accidental disability or death caused by non-intervention factors occurred during the study period, and he withdrew from the study;
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.