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In this clinical trial, the investigators aim to examine the impact of a 12-week early time-restricted carbohydrate consumption diet on weight loss and glucose metabolism in patients with overweight/obesity and type 2 diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eTRC diet | Experimental |
| |
| Control diet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eTRC diet | Behavioral | 12-week dietary prescription with moderate energy restriction (approximately 200 kcal/day) focusing on the distribution of macronutrients within the day so as to avoid carbohydrate consumption after lunch |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic control | Change in plasma levels of glycated hemoglobin | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose tolerance | Glucose tolerance will be measured as the area under the curve of plasma glucose levels in response to a 180-minute mixed meal tolerance test (MMTT) | 12 weeks |
| Body weight loss |
| Measure | Description | Time Frame |
|---|---|---|
| Daily glucose variability | Glucose variability will be measured as the coefficient of variation (CV) of glucose levels recorded by continuous glucose monitoring over a 14-day period using a FreeStyle Libre 2 sensor | 14 days |
| Beta cell function |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Natali, MD | University of Pisa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria Pisana | Pisa | PI | 56127 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37971503 | Derived | Trico D, Masoni MC, Baldi S, Cimbalo N, Sacchetta L, Scozzaro MT, Nesti G, Mengozzi A, Nesti L, Chiriaco M, Natali A. Early time-restricted carbohydrate consumption vs conventional dieting in type 2 diabetes: a randomised controlled trial. Diabetologia. 2024 Feb;67(2):263-274. doi: 10.1007/s00125-023-06045-9. Epub 2023 Nov 16. |
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IPD will be shared with other researchers only upon reasonable request to the PI
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Control diet | Behavioral | 12-week dietary prescription with moderate energy restriction (approximately 200 kcal/day) without any recommendations on the distribution of macronutrients within the day |
|
Change in body weight
| 12 weeks |
Beta cell function will be measured as the beta cell glucose sensitivity obtained from mathematical modeling of plasma glucose and C-peptide levels in response to a 180-minute mixed meal tolerance test (MMTT)
| 12 weeks |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |