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Time Restricted Feeding on Impaired Glucose Regulation(TRIG Trial) | Clinical Trials | Clareo Health

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Time Restricted Feeding on Impaired Glucose Regulation(TRIG Trial)

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

NCT03802253•The First Affiliated Hospital of Xiamen University

View on ClinicalTrials.gov

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

The first affiliated hospital of Xiamen university

Xiamen, Fujian, China

Key Dates

Start Date

June 18, 2019

Primary Completion Date

December 31, 2023

Completion Date

January 31, 2024

Last Updated

August 22, 2023

Enrollment

140

ESTIMATED participants

Conditions

Time-Restricted FeedingImpaired Glucose RegulationOverweight/Obese

Interventions

Time Restricted Feeding(TRF)

BEHAVIORAL

Reduced Calorie Diet (RCD)

BEHAVIORAL

Contacts

Changqin Liu, MD&PhD

CONTACT

+8613376986106 liuchangqin@xmu.edu.cn

Xin zheng, MD

CONTACT

+8618705929102 88126386@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 22, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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