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This study is a multi-center, randomized, crossover investigator-initiated trial conducted at Shanghai Sixth People's Hospital and other centers. Each participant will undergo two 12-week dietary intervention phases, separated by a 6-week washout, for a total study duration of 30 weeks. Participants will be randomly assigned in a 1:1 ratio to one of two intervention order: (1) optimized carbohydrate diet-washout-conventional diabetes diet, or (2) conventional diabetes diet-washout-optimized carbohydrate diet. The optimized carbohydrate diet is a modified diet with adjusted carbohydrate composition and proportions, while the conventional diabetes diet adheres to an energy-matched protocol in accordance with diabetes dietary guidelines. The study aims to explore the effects of the optimized carbohydrate diet on blood glucose control and glucose metabolism in patients with type 2 diabetes, and to systematically assess its impact on cognitive function and a range of physiological and psychological indicators (such as depression, anxiety, appetite, sleep, bowel habits and others).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| optimized carbohydrate diet-washout-conventional diabetes diet | Experimental | Group that starts with the optimized carbohydrate diet |
|
| conventional diabetes diet-washout-optimized carbohydrate diet | Experimental | Group that starts with the conventional diabetes diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| optimized carbohydrate diet | Other | In this dietary pattern, 50-60% of total energy is derived from carbohydrates, 15-20% from protein, and 25-30% from fat. Among the carbohydrates, resistant starch (RS) constitutes 15-20% of daily starch intake (around 40 g/day), slowly digestible starch (SDS) 5%, rapidly digestible starch (RDS) 75-80%, with dietary fiber at 20-40g per 1000 kcal and free sugars contributing less than 5% of total energy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the average incremental area under the curve (iAUC) of postprandial blood glucose over 3 hours | Average incremental area under the curve (iAUC) of postprandial blood glucose over 3 hours will be measured at -2, 0, 10, 16, 18, and 28 weeks using the continuous glucose monitoring system. | -2, 0, 10, 16, 18 and 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in other parameters of Continuous Glucose Monitoring | Other parameters of Continuous Glucose Monitoring, including Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), Mean Glucose, Glucose Variability, Glycemic Excursions, Area Under the Curve (AUC), and other relevant metrics, will be assessed at -2, 0, 10, 16, 18, and 28 weeks. | -2, 0, 10, 16, 18 and 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the iAUC of postprandial blood glucose over 3 hours after each meal | The iAUC of postprandial blood glucose over 3 hours after each meal in patients with type 2 diabetes will be measured at -2, 0, 10, 16, 18, and 28 weeks using the continuous glucose monitoring system. | -2, 0, 10, 16, 18 and 28 weeks |
| Change in hepatic fat content |
Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41062131 | Derived | Lu Y, Zhang R, Yang J, Liu D, Wu Q, Long X, Cheng D, Guo J, Li Q, Zhang Y, Kang P, Wang Q, Gao X, Zeng R, Zhang M, Fang Q, Jia W, Ni Y, Li H. Intervention effects of optimised carbohydrate diet in patients with type 2 diabetes: study protocol for a randomised controlled crossover trial. BMJ Open. 2025 Oct 7;15(10):e106756. doi: 10.1136/bmjopen-2025-106756. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| conventional diabetes diet | Other | In this dietary pattern, 50-60% of total energy is derived from carbohydrates, 15-20% from protein, and 25-30% from fat. Among the carbohydrates, resistant starch (RS) constitutes 5% of daily starch intake, slowly digestible starch (SDS) 5%, rapidly digestible starch (RDS) 90%, with dietary fiber at 14g per 1000 kcal and free sugars contributing less than 5% of total energy. |
|
| Change in HbA1c | HbA1c will be measured at baseline, 12, 18 and 30 weeks. HbA1c will be expressed in mmol/mol. | Baseline, 12, 18 and 30 weeks |
| Change in insulin sensitivity | Insulin sensitivity will be assessed at baseline, 12, 18 and 30 weeks. | Baseline, 12, 18 and 30 weeks |
| Change in other clinical biochemical indicators | Other clinical biochemical indicators will be measured at baseline, 4, 8, 12, 18, 22, 26 and 30 weeks. | Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks |
| Change in blood glucose | Fasting blood glucose will be measured at baseline, 4, 8, 12, 18, 22, 26 and 30 weeks. During meal tolerance test (MTT) at baseline, 12, 18 and 30 weeks, blood glucose at 0, 30, 60, 90, 120 minutes will be measured. Glucose concentration will be expressed in mmol/L | Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks |
| Change in insulin and C peptide secretion | Fasting insulin and C peptide concentration will be assessed at baseline, 4, 8, 12, 18, 22, 26 and 30 weeks. During meal tolerance test (MTT) at baseline, 12, 18 and 30 weeks, insulin and C peptide concentration at 0, 30, 60, 90, 120 minutes will be measured. Insulin concentration will be expressed in uU/ml. C peptide concentration will be expressed in ng/ml. | Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks |
| Change in anthropometry and body composition parameters | Anthropometry and body composition parameters will be measured at baseline, 4, 8, 12, 18, 22, 26 and 30 weeks. | Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks |
| Change in cognitive function and behavioral performance | Cognitive function changes will be assessed using questionnaires (including the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA, Beijing version), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Trail Making Test, Stroop Color and Word Test, and others) at baseline, 12 18, and 30 weeks. Behavioral performance will be assessed using N-back and other paradigms at baseline, 12, 18, and 30 weeks. In addition, subgroups within the two arms will undergo fMRI to assess cognitive function at baseline, 12 18, and 30 weeks. | Baseline, 12, 18 and 30 weeks |
| Change in appetite | Appetite will be measured by visual analog scales (VAS) and other relevant scales, and will be assessed at baseline, 12, 18, and 30 weeks. | Baseline, 12, 18 and 30 weeks |
| Change in emotion | Emotion will be measured using the PHQ-9 depression screening scale, the Problem Areas in Diabetes (PAID) questionnaire, and other relevant scales at baseline, 12, 18, and 30 weeks. | Baseline, 12, 18 and 30 weeks |
| Change in sleep quality | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire and other methods at baseline, 12, 18, and 30 weeks. | Baseline, 12, 18 and 30 weeks |
| Change in bowel habits | Bowel habits will be assessed using the Bristol Stool Form Scale (BSFS; range: 1-7, with higher scores indicating looser stools) and other relevant scales at baseline, 12, 18, and 30 weeks. | Baseline, 12, 18 and 30 weeks |
| Change in cardiopulmonary exercise testing performance | Cardiopulmonary exercise testing performance will be conducted at baseline, 12, 18 and 30 weeks. | Baseline, 12, 18 and 30 weeks |
| Change in blood lipid profiles | Blood lipid profiles will be measured at baseline, 4, 8, 12, 18, 22, 26 and 30 weeks. | Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks |
Hepatic fat content will be assessed by Fibroscan at baseline, 12, 18 and 30 weeks. |
| Baseline, 12, 18 and 30 weeks |
| Change in the levels of cytokines | The levels of cytokines, including FGF21, adiponectin, A-FABP, LCN2, and others, will be assessed using Enzyme-Linked Immunosorbent Assay (ELISA) and other methods at baseline, 12, 18, and 30 weeks. | Baseline, 12, 18 and 30 weeks |
| Change in immunologic function | The immunologic function will be assessed through isolation and analysis of peripheral blood mononuclear cells at baseline, 12, 18, and 30 weeks. | Baseline, 12, 18 and 30 weeks |
| Change in appetite-related hormones | Concentration of appetite-related hormones (e.g., ghrelin, PYY, GLP-1 and others) will be measured at baseline, 12, 18, and 30 weeks. | Baseline, 12, 18 and 30 weeks |
| Change in multi-omics | Multi-omics research, including metagenomic sequencing, metabolomics analysis, proteomics, lipidomics, genomics, etc., will be assessed at baseline, 4, 8, 12, 18, 22, 26 and 30 weeks. | Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks |
| D004700 | Endocrine System Diseases |