Time Restricted Feeding on Impaired Glucose Regulation(TRIG Trial)

Not Applicable

Recruiting

• Conditions: Time-Restricted Feeding; Impaired Glucose Regulation; Overweight/Obese
• Interventions: Behavioral: Time Restricted Feeding(TRF); Behavioral: Reduced Calorie Diet (RCD)

• Registration Number: NCT03802253
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-14
• Study Start: 2019-06-18
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-19
• Last Update Posted: 2023-08-22
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRF	Time Restricted Feeding(TRF)	Participants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction.
RCD	Reduced Calorie Diet (RCD)	Participants in this group will focus on standard care with daily reduced calorie diet (RCD)

Primary Outcome Measures

Name	Time	Method
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
Changes in HbA1c level (%)	3 months, 6 months and 12 months

Secondary Outcome Measures

Name	Time	Method
Changes in depressive symptoms	3 months, 6 months and 12 months	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.
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 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 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 body weight (Kilograms)	3 months, 6 months and 12 months
Change in β cell function	3 months, 6 months and 12 months	β cell function will be assessed by HOMA-β
Changes in serum alanine aminotransferase levels levels (mmol/L)	3 months, 6 months and 12 months
Changes in Epworth sleepiness scores（ESS)	3 months, 6 months and 12 months	The range of epworth sleepiness scores（ESS) is from 0 to 24 and higher scores mean worse outcome.
Changes in fasting blood glucose (mmol/L)	3 months, 6 months and 12 months
Change in insulin sensitivity	3 months, 6 months and 12 months	Insulin sensitivity will be assessed by HOMA-IR
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 controlled attenuation parameter(dB/m)	3 months, 6 months and 12 months	Controlled attenuation parameter will be assessed by transient elastography (FibroScan(®) ）
Changes in Changes in liver fibrosis	3 months, 6 months and 12 months	Liver fibrosis will be assessed by transient elastography (FibroScan(®) ）

Trial Locations

Locations (1)

The first affiliated hospital of Xiamen university; 🇨🇳 Xiamen, Fujian, China