Time Restricted Feeding on Impaired Glucose Regulation(TRIG Trial)

Xiamen University

Status: Enrolling

Conditions: Time-Restricted Feeding; Overweight/Obese; Impaired Glucose Regulation

Treatments: Behavioral: Reduced Calorie Diet (RCD); Behavioral: Time Restricted Feeding(TRF)

Study type: Interventional

Funder types: Other

Identifiers

NCT03802253

KYH2019-001

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

TRF

Experimental group

Description:

Participants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction.

Treatment:

Behavioral: Time Restricted Feeding(TRF)

RCD

Active Comparator group

Description:

Participants in this group will focus on standard care with daily reduced calorie diet (RCD)

Treatment:

Behavioral: Reduced Calorie Diet (RCD)