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

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ClinicalTrials.gov Identifier: NCT03802253
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Xiamen University

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.

Condition or disease Intervention/treatment Phase
Time-Restricted Feeding Impaired Glucose Regulation Overweight/Obese Behavioral: Time Restricted Feeding(TRF) Behavioral: Reduced Calorie Diet (RCD) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Study to Evaluate the Effects of Time-Restricted Feeding Regimen in Overweight/Obese Subjects With Impaired Glucose Regulation
Actual Study Start Date : June 18, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: TRF
Participants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction.
Behavioral: 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.

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.




Primary Outcome Measures :
  1. Changes in HbA1c level (%) [ Time Frame: 3 months, 6 months and 12 months ]
  2. Change in serum fasting insulin levels (pmol/L) [ Time Frame: 3 months, 6 months and 12 months ]
  3. Incidence of regression to normoglycaemia among the studied population [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Changes in body weight (Kilograms) [ Time Frame: 3 months, 6 months and 12 months ]
  2. Changes in waist circumference (cm) [ Time Frame: 3 months, 6 months and 12 months ]
  3. Change in body mass index (kg/m2) [ Time Frame: 3 months, 6 months and 12 months ]
  4. Changes in systolic pressure (mmHg) [ Time Frame: 3 months, 6 months and 12 months ]
  5. Changes in diastolic pressure (mmHg) [ Time Frame: 3 months, 6 months and 12 months ]
  6. Changes in fasting blood glucose (mmol/L) [ Time Frame: 3 months, 6 months and 12 months ]
  7. Change in β cell function [ Time Frame: 3 months, 6 months and 12 months ]
    β cell function will be assessed by HOMA-β

  8. Change in insulin sensitivity [ Time Frame: 3 months, 6 months and 12 months ]
    Insulin sensitivity will be assessed by HOMA-IR

  9. Changes in serum total cholesterol levels (mmol/L) [ Time Frame: 3 months, 6 months and 12 months ]
  10. Changes in serum low density lipoprotein cholesterol levels (mmol/L) [ Time Frame: 3 months, 6 months and 12 months ]
  11. Changes in serum triglyceride levels (mmol/L) [ Time Frame: 3 months, 6 months and 12 months ]
  12. Changes in serum high density lipoprotein cholesterol levels (mmol/L) [ Time Frame: 3 months, 6 months and 12 months ]
  13. Changes in serum alanine aminotransferase levels levels (mmol/L) [ Time Frame: 3 months, 6 months and 12 months ]
  14. Changes in serum aspartate aminotransferase levels (mmol/L) [ Time Frame: 3 months, 6 months and 12 months ]
  15. Changes in serum gamma glutamyltranspeptidase levels (mmol/L) [ Time Frame: 3 months, 6 months and 12 months ]
  16. 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(®) )

  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 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.

  19. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802253


Contacts
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Contact: Changqin Liu, MD&PhD +8613376986106 ext +8613376986106 liuchangqin@xmu.edu.cn
Contact: Xin zheng, MD +8618705929102 88126386@qq.com

Locations
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China, Fujian
The first affiliated hospital of Xiamen university Recruiting
Xiamen, Fujian, China, 361003
Contact: Changqin Liu, MD    +86-133 7698 6106    liuchangqin@xmu.edu.cn   
Sponsors and Collaborators
The First Affiliated Hospital of Xiamen University
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Responsible Party: The First Affiliated Hospital of Xiamen University
ClinicalTrials.gov Identifier: NCT03802253    
Other Study ID Numbers: KYH2019-001
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight