Active — Not RecruitingNot Applicable

Time Restricted Eating on Impaired Glucose Regulation(TRIG Trial)

China142 participantsStarted 2020-05-04

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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) ;

What they're measuring

Incidence of regression to normoglycaemia among the studied population

Timeframe: 12 months

Trial details

NCT IDNCT03802253

SponsorThe First Affiliated Hospital of Xiamen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-31

View on ClinicalTrials.gov More Impaired Glucose Regulation trials