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

April 8, 2026 updated by: The First Affiliated Hospital of Xiamen University

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

We evaluated the effects of Time-Restricted Eating (TRE) regimen on Impaired Glucose Regulation (IGR) in comparison with overweight/obese patients receiving standard of care over 12 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
142

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361003
        • The First Affiliated Hospital of Xiamen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: RCD
Participants in this group will focus on standard care with daily reduced calorie diet (RCD)
Behavioral: Reduced Calorie Diet (RCD)
Participants will receive a diet of 1200-1500kcal/d and keep their usual eating pattern.
Experimental: TRE
Participants in this group will focus on time restricted eating (TRE) in addition to daily calorie restriction.
Behavioral: Time Restricted eating(TRE)
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 eating time.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of regression to normoglycaemia among the studied population
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in serum fasting insulin levels (pmol/L)
Time Frame: 3 months, 6 months and 12 months
3 months, 6 months and 12 months
Changes in body weight (Kilograms)
Time Frame: 3 months, 6 months and 12 months
3 months, 6 months and 12 months
Changes in waist circumference (cm)
Time Frame: 3 months, 6 months and 12 months
3 months, 6 months and 12 months
Change in body mass index (kg/m2)
Time Frame: 3 months, 6 months and 12 months
3 months, 6 months and 12 months
Changes in systolic pressure (mmHg)
Time Frame: 3 months, 6 months and 12 months
3 months, 6 months and 12 months
Changes in diastolic pressure (mmHg）
Time Frame: 3 months, 6 months and 12 months
3 months, 6 months and 12 months
Changes in fasting blood glucose (mmol/L)
Time Frame: 3 months, 6 months and 12 months
3 months, 6 months and 12 months
Change in β cell function
Time Frame: 3 months, 6 months and 12 months
β cell function will be assessed by HOMA-β
3 months, 6 months and 12 months
Change in insulin sensitivity
Time Frame: 3 months, 6 months and 12 months
Insulin sensitivity will be assessed by HOMA-IR
3 months, 6 months and 12 months
Changes in serum total cholesterol levels (mmol/L)
Time Frame: 3 months, 6 months and 12 months
3 months, 6 months and 12 months
Changes in serum low density lipoprotein cholesterol levels (mmol/L)
Time Frame: 3 months, 6 months and 12 months
3 months, 6 months and 12 months
Changes in serum triglyceride levels (mmol/L)
Time Frame: 3 months, 6 months and 12 months
3 months, 6 months and 12 months
Changes in serum high density lipoprotein cholesterol levels (mmol/L)
Time Frame: 3 months, 6 months and 12 months
3 months, 6 months and 12 months
Changes in serum alanine aminotransferase levels levels (mmol/L)
Time Frame: 3 months, 6 months and 12 months
3 months, 6 months and 12 months
Changes in serum aspartate aminotransferase levels (mmol/L)
Time Frame: 3 months, 6 months and 12 months
3 months, 6 months and 12 months
Changes in serum gamma glutamyltranspeptidase levels (mmol/L)
Time Frame: 3 months, 6 months and 12 months
3 months, 6 months and 12 months
Changes in controlled attenuation parameter(dB/m)
Time Frame: 3 months, 6 months and 12 months
Controlled attenuation parameter will be assessed by transient elastography (FibroScan(®) ）
3 months, 6 months and 12 months
Changes in Changes in liver fibrosis
Time Frame: 3 months, 6 months and 12 months
Liver fibrosis will be assessed by transient elastography (FibroScan(®) ）
3 months, 6 months and 12 months
Changes in Epworth sleepiness scores（ESS)
Time Frame: 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.
3 months, 6 months and 12 months
Changes in depressive symptoms
Time Frame: 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.
3 months, 6 months and 12 months
Changes in HbA1c level (%)
Time Frame: Time Frame: 3 months, 6 months and 12 months
Time Frame: 3 months, 6 months and 12 months
Incidence of impaired glucose regulation progressing to diabetes
Time Frame: 12 months
Incidence of impaired glucose regulation progressing to diabetes
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital of Xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 4, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KYH2019-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Impaired Glucose Regulation

Clinical Trials on Reduced Calorie Diet (RCD)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings