Active, not recruiting
Not applicable
Time Restricted Eating on Impaired Glucose Regulation(TRIG Trial)
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
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)
| Facility | City | Region | Status |
| The first affiliated hospital of Xiamen university |
Xiamen |
Fujian |
|
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