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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRE | Experimental | Participants in this group will focus on time restricted eating (TRE) in addition to daily calorie restriction. |
|
| RCD | Active Comparator | Participants in this group will focus on standard care with daily reduced calorie diet (RCD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time Restricted eating(TRE) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of regression to normoglycaemia among the studied population | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of impaired glucose regulation progressing to diabetes | Incidence of impaired glucose regulation progressing to diabetes | 12 months |
| Changes in body weight (Kilograms) | 3 months, 6 months and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Xiamen university | Xiamen | Fujian | 361003 | China |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
| Reduced Calorie Diet (RCD) | Behavioral | Participants will receive a diet of 1200-1500kcal/d and keep their usual eating pattern. |
|
| 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 | β cell function will be assessed by HOMA-β | 3 months, 6 months and 12 months |
| Change in insulin sensitivity | Insulin sensitivity will be assessed by HOMA-IR | 3 months, 6 months and 12 months |
| 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 Changes in liver fibrosis | Liver fibrosis will be assessed by transient elastography (FibroScan(®) ) | 3 months, 6 months and 12 months |
| Changes in controlled attenuation parameter(dB/m) | Controlled attenuation parameter will be assessed by transient elastography (FibroScan(®) ) | 3 months, 6 months and 12 months |
| 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 |
| 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 |
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |