Gestational Diabetes MellitusNCT06431997
A Study of the Intervention of Time-restricted Eating in High-risk Populations of GDM
A study testing Time-limited eating in people with Gestational Diabetes Mellitus and Dietary Habits, run by Fudan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus, Dietary Habits, Lifestyle Intervention
- What is being tested?
- Time-limited eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2024to 10 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-50 years;
- 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);
- Less than 14 weeks of gestation;
- Able to read and complete questionnaires in Chinese;
- singleton pregnancy.
Who cannot join
- 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);
- 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 pregnancy);
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- 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；
- Considered by the researchers to be ineligible for participation.
- 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, etc.
- 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;
- Accidental disability or death caused by non-intervention factors occurred during the study period, and he withdrew from the study;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200011
About this study
Official title: Effects of Time-restricted Eating on the Incidence of Gestational Diabetes Mellitus in High-risk Populations: a Randomized Controlled Study
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 .
Read the detailed description
Investigators present a multicenter, open-label and parallel-group randomized study. Total 240 women in early pregnancy were randomly assigned to TRE group and SOC (standard of care) group according to the ratio of 1: 1. Participants assigned to the TRE group will be instructed to consume prescribed calories in a 10-hour eating window (from 8:30 am to 18:30 pm) each day and only noncaloric beverages were permitted outside of the eating window over 3 months (from 14-26 gestational weeks). Participants in the SOC group will be instructed to consume prescribed calories following habitual daily eating schedule over 3 months. All participants should follow moderate-intensity physical activity for about 30 minutes every day, and receive diet and exercise counseling during the study period. GDM was diagnosed by 75g oral glucose tolerance test (OGTT) test at about 26 gestational weeks.
- Conditions
- Gestational Diabetes Mellitus, Dietary Habits, Lifestyle Intervention, Randomized Controlled Study
- Being tested
- Time-limited eating
- Keywords
- Gestational Diabetes Mellitus, Metabolic Diseases
- Medical subject headings
- Diabetes, Gestational, Feeding Behavior, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-limited eatingBehavioural
All participants will be instructed to follow a diet of 1800-2200 kcal/d (50-60% of energy from carbohydrate, 30% from protein, 10-20% from fat) based primarily on Dietary Guidelines for Chinese Residents (2022), Dietary guidelines for pregnant women and Guideline of Diagnosis and Treatment of Hyperglycemia in Pregnancy (2022). Participants assigned to the TRE group will be instructed to consume prescribed calories in a 10-hour eating window (from 8:30 am to 18:30 pm) each day and only noncaloric beverages were permitted outside of the eating window over 3 months (from 14-26 gestational weeks). Participants in the SOC group will be instructed to consume prescribed calories following habitual daily eating schedule over 3 months.
| Study group | Role | What they receive |
|---|---|---|
| TRE(Time-restricted eating group) | Experimental | Participants assigned to the TRE group will be instructed to consume prescribed calories in a 10-hour eating window (from 8:30 am to 18:30 pm) each day and only noncaloric beverages were permitted outside of the eating window over 3 months (from 14-26 gestational weeks). Receives: Behavioral: Time-limited eating |
| SOC (standard of care group) | No intervention | Participants in the SOC group will be instructed to consume prescribed calories following habitual daily eating schedule over 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of GDM
Diagnosed by the 75g oral glucose tolerance test (OGTT).
Measured: 26 gestational weeks
Secondary outcomes (23)
Number of newborns with macrosomia
Number of newborns with birth weight ≥4000g.
Measured: At delivery
Number of newborns with low birth weight
Number of newborns with birth weight <2500g.
Measured: At delivery
Number of newborns large for gestational age (LGA)
Number of newborns with weight lies above the 90th percentile for the gestational age.
Measured: At delivery
Number of newborns small for gestational age (SGA)
Number of newborns with weight lies below the 10th percentile for the gestational age.
Measured: At delivery
Incidence of shoulder dystocia
The incidence of the condition in which normal traction on the fetal head does not lead to the delivery of the shoulders.
Measured: At delivery
Number of newborns with birth injury
Number of newborns with an impairment of the neonate's body function or structure due to an adverse event that occurred at birth.
Measured: At delivery
Number of neonatus with neonatal intensive care unit (NICU) admission
Number of neonatus with neonatal intensive care unit (NICU) admission.
Measured: Within the first 28 days after delivery
Number of neonatus with neonatal respiratory distress
Number of neonatus with clinical symptoms including tachypnea, nasal flaring, grunting, retractions (subcostal, intercostal, supracostal, jugular), cyanosis, apnea, bradypnea, irregular breathing, inspiratory stridor, wheeze and hypoxia, etc.
Measured: Within the first 28 days after delivery
Number of neonatus with hypoglycemia
Number of neonatus with venous glucose levels <2.6mmol/L.
Measured: Within the first 48 hours after delivery
Number of neonatus with pathologic jaundice
Jaundice that arises from factors that alter the usual process involved in bilirubin metabolism in the liver that requires treatment.
Measured: Within the first 28 days after delivery
Number of neonatus with intraventricular hemorrhage (IVH) of II grade or above
Intraventricular hemorrhage (IVH) of II grade or above diagnosed by ultrasound.
Measured: Within the first 28 days after delivery
Number of neonatus with necrotizing enterocolitis (NEC)
Necrotizing enterocolitis (NEC) diagnosed by radiography or surgery.
Measured: Within the first 28 days after delivery
Number of neonatus managed with assisted ventilation >24 hours via endotracheal tube.
Number of neonatus managed with assisted ventilation >24 hours via endotracheal tube.
Measured: Within 72 hours of birth
Number of neonatus with sepsis.
Number of neonatus with septicemia ascertained by blood culture.
Measured: Within the first 28 days after delivery
The incidence of neonatal death.
The incidence of deaths among live births during the first 28 completed days of life.
Measured: Within the first 28 days after delivery
The level of maternal fasting plasma insulin
Maternal fasting plasma insulin level.
Measured: at 24-28 gestational weeks
The level of maternal HbA1c
Maternal venous glycosylated hemoglobin A1c (HbA1c) level.
Measured: at 24-28 gestational weeks
Insulin resistance calculated by homeostatic model assessment (HOMA-IR)
Insulin resistance calculated by homeostatic model assessment (HOMA-IR). HOMA-IR=fasting plasma glucose (FPG)× fasting plasma insulin (FINS)/22.5. The higher HOMA-IR value indicates higher severity of insulin resistance.
Measured: at 24-28 gestational weeks
Maternal lipid profile
Level of maternal venous low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides and total cholesterol.
Measured: at 24-28 gestational weeks
Maternal change in depression, quality of sleep and quality of life
Maternal change in depression, quality of sleep and quality of life measured by the Patient Health Questionnaire-9 (PHQ-9), Pittsburgh sleep quality index (PSQI) and 12-item Short-Form Health Survey Questionnaire (SF-12) according to pre-pregnancy status and 24-28 gestational weeks.
The Patient Health Questionnaire-9 (PHQ-9): Scores range from 0 to 27, with higher scores indicating severer depression. The standard cut-off score for screening to identify possible major depression is 10 or above.
Pittsburgh sleep quality index (PSQI): Scores range from 0 to 21, with higher scores indicating worse sleep quality.
12-item Short-Form Health Survey Questionnaire (SF-12): physical component score (PCS) range from 0 to 100, higher scores are better.
Measured: From pre-pregnancy to 24-28 gestational weeks
Gestational weight gain
Measured according to pre-pregnancy weight and weight at 24-28 gestational weeks.
Measured: From pre-pregnancy to 24-28 gestational weeks
Change in waist circumference
Measured according to pre-pregnancy waist circumference and waist circumference at 24-28 gestational weeks.
Measured: From pre-pregnancy to 24-28 gestational weeks
Incidence of maternal morbidities
Incidence of hypertensive disorders of pregnancy, hydramnios, placental abruption, preterm/prelabor rupture of membranes (P/PROM), preterm birth, chorioamnionitis, postpartum hemorrhage and still birth.
Measured: From 24-28 gestational weeks to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start27 Apr 2024
- Primary completion23 Mar 2026
- Study completion10 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Maternity & Child Healthcare Hospital
- Responsible party
- Principal investigator, Yu Xiong, Obstetrics & Gynecology Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431997
- Sponsor's protocol ID
- FD153502
- Status last verified
- Jul 2026
- First submitted
- 23 Apr 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Time-restricted Eating on the Incidence of Gestational Diabetes Mellitus in High-risk Populations: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06431997
- Acronym / sponsor ID
- FD153502
- Conditions
- Gestational Diabetes Mellitus, Dietary Habits, Lifestyle Intervention, Randomized Controlled Study
- Keywords
- Gestational Diabetes Mellitus, Metabolic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Shenzhen Maternity & Child Healthcare Hospital
- Study start
- 27 Apr 2024 (actual)
- Primary completion
- 23 Mar 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
Investigators present a multicenter, open-label and parallel-group randomized study. Total 240 women in early pregnancy were randomly assigned to TRE group and SOC (standard of care) group according to the ratio of 1: 1. Participants assigned to the TRE group will be instructed to consume prescribed calories in a 10-hour eating window (from 8:30 am to 18:30 pm) each day and only noncaloric beverages were permitted outside of the eating window over 3 months (from 14-26 gestational weeks). Participants in the SOC group will be instructed to consume prescribed calories following habitual daily eating schedule over 3 months. All participants should follow moderate-intensity physical activity for about 30 minutes every day, and receive diet and exercise counseling during the study period. GDM was diagnosed by 75g oral glucose tolerance test (OGTT) test at about 26 gestational weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRE(Time-restricted eating group) | Experimental | Behavioral: Time-limited eatingParticipants assigned to the TRE group will be instructed to consume prescribed calories in a 10-hour eating window (from 8:30 am to 18:30 pm) each day and only noncaloric beverages were permitted outside of the eating window over 3 months (from 14-26 gestational weeks). |
| SOC (standard of care group) | No intervention | –Participants in the SOC group will be instructed to consume prescribed calories following habitual daily eating schedule over 3 months. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18-50 years;
- 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);
- Less than 14 weeks of gestation;
- Able to read and complete questionnaires in Chinese;
- singleton pregnancy.
Key exclusion criteria (18 listed)
- 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);
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-limited eatingAll participants will be instructed to follow a diet of 1800-2200 kcal/d (50-60% of energy from carbohydrate, 30% from protein, 10-20% from fat) based primarily on Dietary Guidelines for Chinese Residents (2022), Dietary guidelines for pregnant women and Guideline of Diagnosis and Treatment of Hyperglycemia in Pregnancy (2022). Participants assigned to the TRE group will be instructed to consume prescribed calories in a 10-hour eating window (from 8:30 am to 18:30 pm) each day and only noncaloric beverages were permitted outside of the eating window over 3 months (from 14-26 gestational weeks). Participants in the SOC group will be instructed to consume prescribed calories following habitual daily eating schedule over 3 months. | Behavioural | TRE(Time-restricted eating group) |
Primary outcome
The incidence of GDM
Time frame: 26 gestational weeks
Diagnosed by the 75g oral glucose tolerance test (OGTT).
23 secondary outcomes
Number of newborns with macrosomia
Time frame: At delivery
Number of newborns with low birth weight
Time frame: At delivery
Number of newborns large for gestational age (LGA)
Time frame: At delivery
Number of newborns small for gestational age (SGA)
Time frame: At delivery
Incidence of shoulder dystocia
Time frame: At delivery
Number of newborns with birth injury
Time frame: At delivery
Number of neonatus with neonatal intensive care unit (NICU) admission
Time frame: Within the first 28 days after delivery
Number of neonatus with neonatal respiratory distress
Time frame: Within the first 28 days after delivery
Number of neonatus with hypoglycemia
Time frame: Within the first 48 hours after delivery
Number of neonatus with pathologic jaundice
Time frame: Within the first 28 days after delivery
Number of neonatus with intraventricular hemorrhage (IVH) of II grade or above
Time frame: Within the first 28 days after delivery
Number of neonatus with necrotizing enterocolitis (NEC)
Time frame: Within the first 28 days after delivery
Number of neonatus managed with assisted ventilation >24 hours via endotracheal tube.
Time frame: Within 72 hours of birth
Number of neonatus with sepsis.
Time frame: Within the first 28 days after delivery
The incidence of neonatal death.
Time frame: Within the first 28 days after delivery
The level of maternal fasting plasma insulin
Time frame: at 24-28 gestational weeks
The level of maternal HbA1c
Time frame: at 24-28 gestational weeks
Insulin resistance calculated by homeostatic model assessment (HOMA-IR)
Time frame: at 24-28 gestational weeks
Maternal lipid profile
Time frame: at 24-28 gestational weeks
Maternal change in depression, quality of sleep and quality of life
Time frame: From pre-pregnancy to 24-28 gestational weeks
Gestational weight gain
Time frame: From pre-pregnancy to 24-28 gestational weeks
Change in waist circumference
Time frame: From pre-pregnancy to 24-28 gestational weeks
Incidence of maternal morbidities
Time frame: From 24-28 gestational weeks to delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-limited eating in people with Gestational Diabetes Mellitus and Dietary Habits, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of GDM (time frame: 26 gestational weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.