Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
NCT06431997

A Study of the Intervention of Time-restricted Eating in High-risk Populations of GDM

Led by Fudan University · Updated on 2025-11-21

240

Participants Needed

1

Research Sites

136 weeks

Total Duration

On this page

Sponsors

F

Fudan University

Lead Sponsor

S

Shenzhen Maternity & Child Healthcare Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 .

CONDITIONS

Official Title

A Study of the Intervention of Time-restricted Eating in High-risk Populations of GDM

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-50 years
  • At high risk for gestational diabetes mellitus, including 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), low HDL cholesterol (<1 mmol/L), high triglycerides (>2.8 mmol/L), previous GDM, previous macrosomia delivery, polycystic ovary syndrome, repeated positive fasting urine glucose in first trimester, or age over 45 years
  • Less than 14 weeks of gestation
  • Able to read and complete questionnaires in Chinese
  • Singleton pregnancy
Not Eligible

You will not qualify if you...

  • Pregestational diabetes or 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 (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, or Orlistat
  • Severe comorbidities including cardiac, kidney, liver diseases, autoimmune diseases, uncontrolled thyroid disease, or cancer
  • Fetal malformations or chromosomal abnormalities
  • Cervical insufficiency or history of spontaneous preterm birth
  • Exercise contraindications such as continuous vaginal bleeding, threatened premature labor, placenta previa, premature rupture of membranes, or severe anemia
  • Drug abuse including narcotics, psychotropic substances, tobacco, or alcohol
  • Severe and persistent nausea and vomiting causing dehydration, ketosis, or acidosis (hyperemesis gravidarum)
  • On a special or prescribed diet for other reasons
  • Eating window less than 10 hours

AI-Screening

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Trial Site Locations

Total: 1 location

1

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 200011

Actively Recruiting

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Research Team

Y

Ying Zhao, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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