Clinical trial NCT03802253: Time Restricted Feeding on Impaired Glucose Regulation(TRIG Trial)
Official title: Study to Evaluate the Effects of Time-Restricted Feeding Regimen in Overweight/Obese Subjects With Impaired Glucose Regulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Time-Restricted Feeding
Impaired Glucose Regulation
Overweight/Obese
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Primary outcomes:
measure: Changes in HbA1c level (%)
timeFrame: 3 months, 6 months and 12 months
measure: Change in serum fasting insulin levels (pmol/L)
timeFrame: 3 months, 6 months and 12 months
measure: Incidence of regression to normoglycaemia among the studied population
timeFrame: 12 months
Secondary outcomes:
measure: Changes in body weight (Kilograms)
timeFrame: 3 months, 6 months and 12 months
measure: Changes in waist circumference (cm)
timeFrame: 3 months, 6 months and 12 months
measure: Change in body mass index (kg/m2)
timeFrame: 3 months, 6 months and 12 months
measure: Changes in systolic pressure (mmHg)
timeFrame: 3 months, 6 months and 12 months
measure: Changes in diastolic pressure (mmHg）
timeFrame: 3 months, 6 months and 12 months
measure: Changes in fasting blood glucose (mmol/L)
timeFrame: 3 months, 6 months and 12 months
measure: Change in β cell function
timeFrame: 3 months, 6 months and 12 months
measure: Change in insulin sensitivity
timeFrame: 3 months, 6 months and 12 months
measure: Changes in serum total cholesterol levels (mmol/L)
timeFrame: 3 months, 6 months and 12 months
measure: Changes in serum low density lipoprotein cholesterol levels (mmol/L)
timeFrame: 3 months, 6 months and 12 months
measure: Changes in serum triglyceride levels (mmol/L)
timeFrame: 3 months, 6 months and 12 months
measure: Changes in serum high density lipoprotein cholesterol levels (mmol/L)
timeFrame: 3 months, 6 months and 12 months
measure: Changes in serum alanine aminotransferase levels levels (mmol/L)
timeFrame: 3 months, 6 months and 12 months
measure: Changes in serum aspartate aminotransferase levels (mmol/L)
timeFrame: 3 months, 6 months and 12 months
measure: Changes in serum gamma glutamyltranspeptidase levels (mmol/L)
timeFrame: 3 months, 6 months and 12 months
measure: Changes in controlled attenuation parameter(dB/m)
timeFrame: 3 months, 6 months and 12 months
measure: Changes in Changes in liver fibrosis
timeFrame: 3 months, 6 months and 12 months
measure: Changes in Epworth sleepiness scores（ESS)
timeFrame: 3 months, 6 months and 12 months
measure: Changes in depressive symptoms
timeFrame: 3 months, 6 months and 12 months
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The first affiliated hospital of Xiamen university
state: Fujian
Study officials:
References: