Time Restricted Feeding on Impaired Glucose Regulation(TRIG Trial)

Impaired Glucose Regulation Clinical Trial

— TRIG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03802253
• Other study ID #: KYH2019-001
• Status: Recruiting
• Phase: N/A
• Start date: June 18, 2019
• Est. completion date: January 31, 2024

Study information

• Verified date: August 2023
• Source: The First Affiliated Hospital of Xiamen University
• Contact: Changqin Liu, MD&PhD
• Phone: +8613376986106
• Email: liuchangqin[@]xmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• Reduced Calorie Diet (RCD)
Participants will receive a diet of 1200-1500kcal/d and keep their usual eating pattern.

Locations

Country	Name	City	State
China	The first affiliated hospital of Xiamen university	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in HbA1c level (%)		3 months, 6 months and 12 months
Primary	Change in serum fasting insulin levels (pmol/L)		3 months, 6 months and 12 months
Primary	Incidence of regression to normoglycaemia among the studied population		12 months
Secondary	Changes in body weight (Kilograms)		3 months, 6 months and 12 months
Secondary	Changes in waist circumference (cm)		3 months, 6 months and 12 months
Secondary	Change in body mass index (kg/m2)		3 months, 6 months and 12 months
Secondary	Changes in systolic pressure (mmHg)		3 months, 6 months and 12 months
Secondary	Changes in diastolic pressure (mmHg)		3 months, 6 months and 12 months
Secondary	Changes in fasting blood glucose (mmol/L)		3 months, 6 months and 12 months
Secondary	Change in ß cell function	ß cell function will be assessed by HOMA-ß	3 months, 6 months and 12 months
Secondary	Change in insulin sensitivity	Insulin sensitivity will be assessed by HOMA-IR	3 months, 6 months and 12 months
Secondary	Changes in serum total cholesterol levels (mmol/L)		3 months, 6 months and 12 months
Secondary	Changes in serum low density lipoprotein cholesterol levels (mmol/L)		3 months, 6 months and 12 months
Secondary	Changes in serum triglyceride levels (mmol/L)		3 months, 6 months and 12 months
Secondary	Changes in serum high density lipoprotein cholesterol levels (mmol/L)		3 months, 6 months and 12 months
Secondary	Changes in serum alanine aminotransferase levels levels (mmol/L)		3 months, 6 months and 12 months
Secondary	Changes in serum aspartate aminotransferase levels (mmol/L)		3 months, 6 months and 12 months
Secondary	Changes in serum gamma glutamyltranspeptidase levels (mmol/L)		3 months, 6 months and 12 months
Secondary	Changes in controlled attenuation parameter(dB/m)	Controlled attenuation parameter will be assessed by transient elastography (FibroScan(®) )	3 months, 6 months and 12 months
Secondary	Changes in Changes in liver fibrosis	Liver fibrosis will be assessed by transient elastography (FibroScan(®) )	3 months, 6 months and 12 months
Secondary	Changes in Epworth sleepiness scores(ESS)	The range of epworth sleepiness scores(ESS) is from 0 to 24 and higher scores mean worse outcome.	3 months, 6 months and 12 months
Secondary	Changes in depressive symptoms	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.	3 months, 6 months and 12 months