Time Restricted Eating on Impaired Glucose Regulation(TRIG Trial)

N/AActive Not RecruitingNCT03802253

The First Affiliated Hospital of Xiamen University142 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

142

Conditions

Impaired Glucose Regulation Overweight/Obese Time-restricted Eating

Interventions

Time Restricted eating(TRE)BEHAVIORAL

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)BEHAVIORAL

Participants will receive a diet of 1200-1500kcal/d and keep their usual eating pattern.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

The first affiliated hospital of Xiamen university

Xiamen, Fujian, China

Outcomes

Primary Outcomes

Incidence of regression to normoglycaemia among the studied population

Time frame: 12 months