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Time Restricted Feeding on Impaired Glucose Regulation(TRIG Trial) (TRIG)

Primary Purpose

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

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Time Restricted Feeding(TRF)

Reduced Calorie Diet (RCD)

About this trial

This is an interventional prevention trial for Time-Restricted Feeding

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The first affiliated hospital of Xiamen universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TRF

RCD

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in HbA1c level (%)

Change in serum fasting insulin levels (pmol/L)

Incidence of regression to normoglycaemia among the studied population

Secondary Outcome Measures

Changes in body weight (Kilograms)

Changes in waist circumference (cm)

Change in body mass index (kg/m2)

Changes in systolic pressure (mmHg)

Changes in diastolic pressure (mmHg）

Changes in fasting blood glucose (mmol/L)

Change in β cell function

β cell function will be assessed by HOMA-β

Change in insulin sensitivity

Insulin sensitivity will be assessed by HOMA-IR

Changes in serum total cholesterol levels (mmol/L)

Changes in serum low density lipoprotein cholesterol levels (mmol/L)

Changes in serum triglyceride levels (mmol/L)

Changes in serum high density lipoprotein cholesterol levels (mmol/L)

Changes in serum alanine aminotransferase levels levels (mmol/L)

Changes in serum aspartate aminotransferase levels (mmol/L)

Changes in serum gamma glutamyltranspeptidase levels (mmol/L)

Changes in controlled attenuation parameter(dB/m)

Controlled attenuation parameter will be assessed by transient elastography (FibroScan(®) ）

Changes in Changes in liver fibrosis

Liver fibrosis will be assessed by transient elastography (FibroScan(®) ）

Changes in Epworth sleepiness scores（ESS)

The range of epworth sleepiness scores（ESS) is from 0 to 24 and higher scores mean worse outcome.

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.

Full Information

NCT ID

NCT03802253

First Posted

January 8, 2019

Last Updated

August 19, 2023

Sponsor

The First Affiliated Hospital of Xiamen University

1. Study Identification

Unique Protocol Identification Number

NCT03802253

Brief Title

Time Restricted Feeding on Impaired Glucose Regulation(TRIG Trial)

Acronym

TRIG

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 18, 2019 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital of Xiamen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TRF

Arm Type

Experimental

Arm Description

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

Arm Title

RCD

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Time Restricted Feeding(TRF)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Reduced Calorie Diet (RCD)

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in HbA1c level (%)

Time Frame

3 months, 6 months and 12 months

Title

Change in serum fasting insulin levels (pmol/L)

Time Frame

3 months, 6 months and 12 months

Title

Incidence of regression to normoglycaemia among the studied population

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Changes in body weight (Kilograms)

Time Frame

3 months, 6 months and 12 months

Title

Changes in waist circumference (cm)

Time Frame

3 months, 6 months and 12 months

Title

Change in body mass index (kg/m2)

Time Frame

3 months, 6 months and 12 months

Title

Changes in systolic pressure (mmHg)

Time Frame

3 months, 6 months and 12 months

Title

Changes in diastolic pressure (mmHg）

Time Frame

3 months, 6 months and 12 months

Title

Changes in fasting blood glucose (mmol/L)

Time Frame

3 months, 6 months and 12 months

Title

Change in β cell function

Description

β cell function will be assessed by HOMA-β

Time Frame

3 months, 6 months and 12 months

Title

Change in insulin sensitivity

Description

Insulin sensitivity will be assessed by HOMA-IR

Time Frame

3 months, 6 months and 12 months

Title

Changes in serum total cholesterol levels (mmol/L)

Time Frame

3 months, 6 months and 12 months

Title

Changes in serum low density lipoprotein cholesterol levels (mmol/L)

Time Frame

3 months, 6 months and 12 months

Title

Changes in serum triglyceride levels (mmol/L)

Time Frame

3 months, 6 months and 12 months

Title

Changes in serum high density lipoprotein cholesterol levels (mmol/L)

Time Frame

3 months, 6 months and 12 months

Title

Changes in serum alanine aminotransferase levels levels (mmol/L)

Time Frame

3 months, 6 months and 12 months

Title

Changes in serum aspartate aminotransferase levels (mmol/L)

Time Frame

3 months, 6 months and 12 months

Title

Changes in serum gamma glutamyltranspeptidase levels (mmol/L)

Time Frame

3 months, 6 months and 12 months

Title

Changes in controlled attenuation parameter(dB/m)

Description

Controlled attenuation parameter will be assessed by transient elastography (FibroScan(®) ）

Time Frame

3 months, 6 months and 12 months

Title

Changes in Changes in liver fibrosis

Description

Liver fibrosis will be assessed by transient elastography (FibroScan(®) ）

Time Frame

3 months, 6 months and 12 months

Title

Changes in Epworth sleepiness scores（ESS)

Description

The range of epworth sleepiness scores（ESS) is from 0 to 24 and higher scores mean worse outcome.

Time Frame

3 months, 6 months and 12 months

Title

Changes in depressive symptoms

Description

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.

Time Frame

3 months, 6 months and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Changqin Liu, MD&PhD

Phone

+8613376986106

Ext

+8613376986106

liuchangqin@xmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Xin zheng, MD

Phone

+8618705929102

88126386@qq.com

Facility Information:

Facility Name

The first affiliated hospital of Xiamen university

City

Xiamen

State/Province

Fujian

ZIP/Postal Code

361003

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Changqin Liu, MD

Phone

+86-133 7698 6106

liuchangqin@xmu.edu.cn

12. IPD Sharing Statement

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Time Restricted Feeding on Impaired Glucose Regulation(TRIG Trial)

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