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Active, not recruiting Not applicable

Time Restricted Eating on Impaired Glucose Regulation(TRIG Trial)

NCT03802253 · tracked via the Priya Life Science China tracker
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)

  • Incidence of regression to normoglycaemia among the studied population — 12 months

Trial sites (1)

FacilityCityRegionStatus
The first affiliated hospital of Xiamen university Xiamen Fujian
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