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Clinical Trials in China / NCT03802253
Active, not recruiting Not applicable

Time Restricted Eating on Impaired Glucose Regulation(TRIG Trial)

NCT03802253 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital of Xiamen University
Phase
Not applicable
Started
2020-05-04
Last updated
2026-04-13

Condition(s) studied

Impaired Glucose RegulationOverweight/ObeseTime-restricted Eating

Investigational drug(s) / intervention(s)

Time Restricted eating(TRE)Reduced Calorie Diet (RCD)

Time Restricted eating(TRE): Participants will receive a diet of 1200-1500kcal/d and be instructed to eat only during a window of 8 hours (Finishing the last meal before 4pm) in the first 6 months. 6 months later, Participants will receive a diet of 1200-1500kcal/d without a restriction of eating time.

Reduced Calorie Diet (RCD): Participants will receive a diet of 1200-1500kcal/d and keep their usual eating pattern.

Study summary

We evaluated the effects of Time-Restricted Eating (TRE) regimen on Impaired Glucose Regulation (IGR) in comparison with overweight/obese patients receiving standard of care over 12 months.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Aged ≥ 18 year 2. Diagnosis of impaired glucose regulation (i.e. FG between 5.7-6.9mmol/L) +/- impaired glucose tolerance (i.e. 2-hour postprandial PG between 7.8-11.1mmol/L) confirmed by latest OGTT results within 3 months prior to recruitment 3. Body mass index (BMI)of 23.0 to 45.0 kg/m2; Exclusion Criteria: 1. Confirmed diagnosis of DM or on hypoglycaemic treatment 2. Women who are pregnant or breast-feeding at recruitment 3. Patients taking glucocorticoid at recruitment 4. Active and uncontrolled thyroid diseases (including subjects on thyroid replacement therapy or anti-thyroid drugs) or active endocrine diseases such as Cushing's syndrome or Acromegaly at recruitment 5. Serious liver dysfunction or chronic kidney disease (AST or ALT \> 3 times the upper limit of normal, or eGFR\<30 ml/min/1.73 m2); 6. History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months; 7. Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician; 8. Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight) ; 9. Patients who cannot be followed for 24 months (due to a health situation or migration); 10. Patients who are unwilling or unable to give informed consent.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The first affiliated hospital of Xiamen university Xiamen Fujian

More The First Affiliated Hospital of Xiamen University trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03802253 on ClinicalTrials.gov ↗ ← All trials in China