Time Restricted Feeding on Impaired Glucose Regulation(TRIG Trial)

Not Applicable

Recruiting

• Conditions: Time-Restricted Feeding; Impaired Glucose Regulation; Overweight/Obese

• Registration Number: NCT03802253
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-14
• Study Start: 2019-06-18
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-19
• Last Update Posted: 2023-08-22
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in serum fasting insulin levels (pmol/L)	3 months, 6 months and 12 months
Incidence of regression to normoglycaemia among the studied population	12 months
Changes in HbA1c level (%)	3 months, 6 months and 12 months

Secondary Outcome Measures

Name	Time	Method
Changes in waist circumference (cm)	3 months, 6 months and 12 months
Change in body mass index (kg/m2)	3 months, 6 months and 12 months
Changes in systolic pressure (mmHg)	3 months, 6 months and 12 months
Changes in diastolic pressure (mmHg）	3 months, 6 months and 12 months
Changes in serum triglyceride levels (mmol/L)	3 months, 6 months and 12 months
Changes in serum high density lipoprotein cholesterol levels (mmol/L)	3 months, 6 months and 12 months
Changes in serum aspartate aminotransferase levels (mmol/L)	3 months, 6 months and 12 months
Changes in serum gamma glutamyltranspeptidase levels (mmol/L)	3 months, 6 months and 12 months
Changes in body weight (Kilograms)	3 months, 6 months and 12 months
Change in β cell function	3 months, 6 months and 12 months	β cell function will be assessed by HOMA-β
Changes in serum alanine aminotransferase levels levels (mmol/L)	3 months, 6 months and 12 months
Changes in Epworth sleepiness scores（ESS)	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.
Changes in fasting blood glucose (mmol/L)	3 months, 6 months and 12 months
Change in insulin sensitivity	3 months, 6 months and 12 months	Insulin sensitivity will be assessed by HOMA-IR
Changes in serum total cholesterol levels (mmol/L)	3 months, 6 months and 12 months
Changes in serum low density lipoprotein cholesterol levels (mmol/L)	3 months, 6 months and 12 months
Changes in controlled attenuation parameter(dB/m)	3 months, 6 months and 12 months	Controlled attenuation parameter will be assessed by transient elastography (FibroScan(®) ）
Changes in Changes in liver fibrosis	3 months, 6 months and 12 months	Liver fibrosis will be assessed by transient elastography (FibroScan(®) ）
Changes in depressive symptoms	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.

Trial Locations

Locations (1)

The first affiliated hospital of Xiamen university; 🇨🇳 Xiamen, Fujian, China