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Active, Not Recruiting

NCT Number: NCT03802253

Time Restricted Eating on Impaired Glucose Regulation(TRIG Trial)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The first affiliated hospital of Xiamen university

Xiamen, Fujian, 361003, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Time Restricted eating(TRE)

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 eating time.

Reduced Calorie Diet (RCD)

Behavioral

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

Primary outcomes

  1. Incidence of regression to normoglycaemia among the studied population

    Time frame: 12 months

Secondary outcomes

  1. Incidence of impaired glucose regulation progressing to diabetes

    Time frame: 12 months

    Incidence of impaired glucose regulation progressing to diabetes

  2. Changes in body weight (Kilograms)

    Time frame: 3 months, 6 months and 12 months

  3. Changes in waist circumference (cm)

    Time frame: 3 months, 6 months and 12 months

  4. Change in body mass index (kg/m2)

    Time frame: 3 months, 6 months and 12 months

  5. Changes in systolic pressure (mmHg)

    Time frame: 3 months, 6 months and 12 months

  6. Changes in diastolic pressure (mmHg)

    Time frame: 3 months, 6 months and 12 months

  7. Changes in fasting blood glucose (mmol/L)

    Time frame: 3 months, 6 months and 12 months

  8. Change in β cell function

    Time frame: 3 months, 6 months and 12 months

    β cell function will be assessed by HOMA-β

  9. Change in insulin sensitivity

    Time frame: 3 months, 6 months and 12 months

    Insulin sensitivity will be assessed by HOMA-IR

  10. Changes in serum total cholesterol levels (mmol/L)

    Time frame: 3 months, 6 months and 12 months

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

    Time frame: 3 months, 6 months and 12 months

  12. Changes in serum triglyceride levels (mmol/L)

    Time frame: 3 months, 6 months and 12 months

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

    Time frame: 3 months, 6 months and 12 months

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

    Time frame: 3 months, 6 months and 12 months

  15. Changes in serum aspartate aminotransferase levels (mmol/L)

    Time frame: 3 months, 6 months and 12 months

  16. Changes in serum gamma glutamyltranspeptidase levels (mmol/L)

    Time frame: 3 months, 6 months and 12 months

  17. Changes in Changes in liver fibrosis

    Time frame: 3 months, 6 months and 12 months

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

  18. 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(®) )

  19. 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.

  20. 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.

  21. Changes in HbA1c level (%)

    Time frame: Time Frame: 3 months, 6 months and 12 months

  22. Change in serum fasting insulin levels (pmol/L)

    Time frame: 3 months, 6 months and 12 months

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Official study title

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

Acronym: TRIG

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jan 14, 2019
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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