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The blood glucose fluctuates greatly in T1DM patients, especially in the middle and late stages of the disease, and carbohydrate (CHO) is the main determinant of postprandial glucose response (PGR). Based on the previous investigation to understand how nutritional habits affect blood glucose control, we will conduct dietary intervention studies in T1DM patients to explore whether the adjustment of dietary pattern is beneficial to blood glucose control, and further explore the relevant mechanism through the detection of related metabolic indicators.
1. Main Objective: To evaluate the effect of changes of carbohydrate intake on glucose control in patients with type 1 diabetes.
1) difference of coefficient of variation (CV), mean amplitude of glycemic excursions (MAGE) , large amplitude of glycemic excursions (LAGE) between the 2 groups; 2) difference of change in HbA1c,GA,1,5-anhydroglucitol (1,5-AG) from baseline between the 2 groups; 3) difference of change in incidence of hypoglycemic events (%), severe hypoglycemia and nocturnal hypoglycemia events from baseline between the 2 groups; 4) difference of change in insulin dose (IU/kg/day) from baseline between the 2 groups.
2. Secondary objective: To explore the possible mechanism of dietary intervention to improve blood glucose control in patients with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| diverse carbohydrate diet | Experimental | Carbohydrate provides 45~55% of total dietary energy, protein 15~20%, and fat 25 ~35%. Among them, 45~50% of carbohydrate supply sources are refined grains, 45~50% of carbohydrate supply sources are whole grains or beans. The total energy is divided into 3 meals per day. The breakfast provides 25~30% of total energy, lunch 30~40%,and dinner 30~35%. |
|
| moderate carbohydrate diet | Other | Carbohydrate provides 45~55% of total dietary energy, protein 15~20%, and fat 25~35%. 90~95% of the carbohydrate supply comes from refined grains. The total energy is divided into 3 meals per day. The breakfast provides 25~30% of total energy, lunch 30~40%,and dinner 30~35%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diverse carbohydrate diet | Other | Carbohydrate provides 45~55% of total dietary energy, protein 15~20%, and fat 25 ~35%. Among them, 45~50% of carbohydrate supply sources are refined grains, 45~50% of carbohydrate supply sources are whole grains or beans. The total energy is divided into 3 meals per day. The breakfast provides 25~30% of total energy, lunch 30~40%,and dinner 30~35%. |
| Measure | Description | Time Frame |
|---|---|---|
| Time in range (TIR) | TIR represents percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L based on CGMS. TIR will be compared between the 2 interventions. | Baseline to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Coefficient of variation of blood glucose(CV) | Reflect glucose fluctuation | Baseline to 2 weeks |
| Mean amplitude of glycemic excursions(MAGE) | Reflect glucose fluctuation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Yang, MD/PhD | Contact | 86-25-83718836 | 6466 | yangt@njmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Tao Yang, MD/PhD | First Affiliated Hospital, Nanjing Medical University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital, Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34836409 | Background | Bell E, Binkowski S, Sanderson E, Keating B, Smith G, Harray AJ, Davis EA. Substantial Intra-Individual Variability in Post-Prandial Time to Peak in Controlled and Free-Living Conditions in Children with Type 1 Diabetes. Nutrients. 2021 Nov 19;13(11):4154. doi: 10.3390/nu13114154. | |
| 34212475 | Background | Clark AL, Yan Z, Chen SX, Shi V, Kulkarni DH, Diwan A, Remedi MS. High-fat diet prevents the development of autoimmune diabetes in NOD mice. Diabetes Obes Metab. 2021 Nov;23(11):2455-2465. doi: 10.1111/dom.14486. Epub 2021 Aug 2. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| moderate carbohydrate diet | Other | Carbohydrate provides 45~55% of total dietary energy, protein 15~20%, and fat 25 ~35%. Among them, 90~95% of carbohydrate supply sources are refined grains. The total energy is divided into 3 meals per day. The breakfast provides 25~30% of total energy, lunch 30~40%,and dinner 30~35%. |
|
| Baseline to 2 weeks |
| Large amplitude of glycemic excursions (LAGE) | Reflect glucose fluctuation | Baseline to 2 weeks |
| Change in HbA1c from baseline | Reflect 2~3 months of glycemic control | Baseline to 14 weeks |
| Change in GA(glycosylated albumin)from baseline | Reflect 2~3 weeks of glycemic control | Baseline to 2 weeks |
| Change in 1,5-anhydroglucitol (1,5-AG) from baseline | Reflect 1~2 weeks of glycemic control | Baseline to 2 weeks and to 14 weeks |
| Time above range(TAR) | TAR represents percentage of time of glucose levels spent over 10.0 mmol/L based on CGMS. TAR will be compared between the 2 interventions. | Baseline to 2 weeks |
| Time below range(TBR) | TBR represents percentage of time of glucose levels spent below 3.9 mmol/L based on CGMS. TBR will be compared between the 2 interventions. | Baseline to 2 weeks |
| Change in total insulin dose from baseline | Baseline to 2 weeks and to 14 weeks |
| Change in blood lipids from baseline | Baseline to 2 weeks and to 14 weeks |
| Change in body weight from baseline | Baseline to 2 weeks and to 14 weeks |
| Daily mean glucose values | Baseline to 2 weeks |
| Number of participants with severe hypoglycemia and nocturnal hypoglycemia events | Reflects the safety of clinical trials | Baseline to 2 weeks and to 14 weeks |
| Change in Incidence of hypoglycemic events from baseline | Reflects the safety of clinical trials | Baseline to 2 weeks and to 14 weeks |
| Change in gut microbiota from baseline | Baseline to 2 weeks and to 14 weeks |
| Change in metabolomics from baseline | Baseline to 2 weeks and to 14 weeks |
| Change in autoimmunity from baseline | Baseline to 14 weeks |
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| D004700 | Endocrine System Diseases |
| D007154 | Immune System Diseases |