Impaired Glucose Regulation, Overweight/Obese, Time-restricted Eating
Conditions
Brief summary
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.
Interventions
BEHAVIORALTime Restricted eating(TRE)
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.
BEHAVIORALReduced Calorie Diet (RCD)
Participants will receive a diet of 1200-1500kcal/d and keep their usual eating pattern.
Sponsors
The First Affiliated Hospital of Xiamen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of regression to normoglycaemia among the studied population | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in body weight (Kilograms) | 3 months, 6 months and 12 months | — |
| 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 fasting blood glucose (mmol/L) | 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 |
| 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 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 alanine aminotransferase levels 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 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 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 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. |
| Changes in HbA1c level (%) | Time Frame: 3 months, 6 months and 12 months | — |
| Change in serum fasting insulin levels (pmol/L) | 3 months, 6 months and 12 months | — |
Countries
China
Outcome results
None listed