Status:
UNKNOWN
Time Restricted Feeding on Impaired Glucose Regulation(TRIG Trial)
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Conditions:
Time-Restricted Feeding
Impaired Glucose Regulation
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
We evaluated the effects of Time-Restricted Feeding (TRF) regimen on Impaired Glucose Regulation (IGR) in comparison with overweight/obese patients receiving standard of care over 12 months.
Eligibility Criteria
Inclusion
- Aged ≥ 18 year
- 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
- Body mass index (BMI)of 23.0 to 45.0 kg/m2;
Exclusion
- Confirmed diagnosis of DM or on hypoglycaemic treatment
- Women who are pregnant or breast-feeding at recruitment
- Patients taking glucocorticoid at recruitment
- 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
- 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);
- History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
- 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;
- Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight) ;
- Patients who cannot be followed for 24 months (due to a health situation or migration);
- Patients who are unwilling or unable to give informed consent.
Key Trial Info
Start Date :
June 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2024
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03802253
Start Date
June 18 2019
End Date
January 31 2024
Last Update
August 22 2023
Active Locations (1)
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1
The first affiliated hospital of Xiamen university
Xiamen, Fujian, China, 361003