Time Restricted Feeding on Impaired Glucose Regulation(TRIG Trial)

NCT ID: NCT03802253

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-18
• Study Completion Date: 2024-01-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

TRF

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

Group Type: EXPERIMENTAL

Time Restricted Feeding(TRF)

Intervention Type: BEHAVIORAL

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.

RCD

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

Group Type: ACTIVE_COMPARATOR

Reduced Calorie Diet (RCD)

Intervention Type: BEHAVIORAL

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

Interventions

Time Restricted Feeding(TRF)

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

Reduced Calorie Diet (RCD)

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The first affiliated hospital of Xiamen university

Xiamen, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Changqin Liu, MD&PhD

Role: CONTACT

liuchangqin@xmu.edu.cn

+8613376986106 ext. +8613376986106

Xin zheng, MD

Role: CONTACT

88126386@qq.com

+8618705929102

Facility Contacts

Changqin Liu, MD

Role: primary

liuchangqin@xmu.edu.cn

+86-133 7698 6106

Other Identifiers

KYH2019-001

Identifier Type: -

Identifier Source: org_study_id