The first affiliated hospital of Xiamen university
Xiamen, Fujian, 361003, China
NCT Number: NCT03802253
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.
This study is active but is not currently recruiting participants.
18 year–70 year
All sexes
Interventional
Not applicable
Xiamen, Fujian, 361003, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Participants will receive a diet of 1200-1500kcal/d and keep their usual eating pattern.
Time frame: 12 months
Time frame: 12 months
Incidence of impaired glucose regulation progressing to diabetes
Time frame: 3 months, 6 months and 12 months
Time frame: 3 months, 6 months and 12 months
Time frame: 3 months, 6 months and 12 months
Time frame: 3 months, 6 months and 12 months
Time frame: 3 months, 6 months and 12 months
Time frame: 3 months, 6 months and 12 months
Time frame: 3 months, 6 months and 12 months
β cell function will be assessed by HOMA-β
Time frame: 3 months, 6 months and 12 months
Insulin sensitivity will be assessed by HOMA-IR
Time frame: 3 months, 6 months and 12 months
Time frame: 3 months, 6 months and 12 months
Time frame: 3 months, 6 months and 12 months
Time frame: 3 months, 6 months and 12 months
Time frame: 3 months, 6 months and 12 months
Time frame: 3 months, 6 months and 12 months
Time frame: 3 months, 6 months and 12 months
Time frame: 3 months, 6 months and 12 months
Liver fibrosis will be assessed by transient elastography (FibroScan(®) )
Time frame: 3 months, 6 months and 12 months
Controlled attenuation parameter will be assessed by transient elastography (FibroScan(®) )
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.
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.
Time frame: Time Frame: 3 months, 6 months and 12 months
Time frame: 3 months, 6 months and 12 months
The First Affiliated Hospital of Xiamen University
Other
Study to Evaluate the Effects of Time-Restricted Eating Regimen in Overweight/Obese Subjects With Impaired Glucose Regulation
Acronym: TRIG
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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