Time Restricted Feeding on Impaired Glucose Regulation(TRIG Trial)

Study Overview
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Brief Summary
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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.

Official Title
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Study to Evaluate the Effects of Time-Restricted Feeding Regimen in Overweight/Obese Subjects With Impaired Glucose Regulation

Conditions
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Time-Restricted Feeding, Impaired Glucose Regulation, Overweight/Obese

Intervention / Treatment
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* Behavioral: Time Restricted Feeding(TRF)
* Behavioral: Reduced Calorie Diet (RCD)


Participation Criteria
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Eligibility Criteria
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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) ; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRF<br>Participants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction. | Behavioral: Time Restricted Feeding(TRF)<br>* 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 feeding time.<br>|
| Active Comparator: RCD<br>Participants in this group will focus on standard care with daily reduced calorie diet (RCD) | Behavioral: Reduced Calorie Diet (RCD)<br>* Participants will receive a diet of 1200-1500kcal/d and keep their usual eating pattern.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HbA1c level (%) |  | 3 months, 6 months and 12 months | 
| Change in serum fasting insulin levels (pmol/L) |  | 3 months, 6 months and 12 months | 
| Incidence of regression to normoglycaemia among the studied population |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight (Kilograms) |  | 3 months, 6 months and 12 months | 
| Changes in waist circumference (cm) |  | 3 months, 6 months and 12 months | 
| Change in body mass index (kg/m2) |  | 3 months, 6 months and 12 months | 
| Changes in systolic pressure (mmHg) |  | 3 months, 6 months and 12 months | 
| Changes in diastolic pressure (mmHg） |  | 3 months, 6 months and 12 months | 
| Changes in fasting blood glucose (mmol/L) |  | 3 months, 6 months and 12 months | 
| Change in β cell function | β cell function will be assessed by HOMA-β | 3 months, 6 months and 12 months | 
| Change in insulin sensitivity | Insulin sensitivity will be assessed by HOMA-IR | 3 months, 6 months and 12 months | 
| Changes in serum total cholesterol levels (mmol/L) |  | 3 months, 6 months and 12 months | 
| Changes in serum low density lipoprotein cholesterol levels (mmol/L) |  | 3 months, 6 months and 12 months | 
| Changes in serum triglyceride levels (mmol/L) |  | 3 months, 6 months and 12 months | 
| Changes in serum high density lipoprotein cholesterol levels (mmol/L) |  | 3 months, 6 months and 12 months | 
| Changes in serum alanine aminotransferase levels levels (mmol/L) |  | 3 months, 6 months and 12 months | 
| Changes in serum aspartate aminotransferase levels (mmol/L) |  | 3 months, 6 months and 12 months | 
| Changes in serum gamma glutamyltranspeptidase levels (mmol/L) |  | 3 months, 6 months and 12 months | 
| Changes in controlled attenuation parameter(dB/m) | Controlled attenuation parameter will be assessed by transient elastography (FibroScan(®) ） | 3 months, 6 months and 12 months | 
| Changes in Changes in liver fibrosis | Liver fibrosis will be assessed by transient elastography (FibroScan(®) ） | 3 months, 6 months and 12 months | 
| Changes in Epworth sleepiness scores（ESS) | The range of epworth sleepiness scores（ESS) is from 0 to 24 and higher scores mean worse outcome. | 3 months, 6 months and 12 months | 
| Changes in depressive symptoms | Depressive symptoms will be assessed by Patient Health Questionnaire-9 (PHQ-9) algorithm scoring method. The range of PHQ-9 is from 0 to 27 and higher scores mean worse outcome. | 3 months, 6 months and 12 months |