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. Primary endpoint: difference of time in range (TIR) between the 2 groups. 2. Secondary endpoint: 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. 1. Effects of dietary intervention on intestinal microenvironment and microflora of type 1 diabetes patients; 2. Effects of dietary intervention on immune function of type 1 diabetes patients; 3. Effects of dietary intervention on metabolomics of type 1 diabetes patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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%.
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%.
First Affiliated Hospital, Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGTime 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.
Time frame: Baseline to 2 weeks
Coefficient of variation of blood glucose(CV)
Reflect glucose fluctuation
Time frame: Baseline to 2 weeks
Mean amplitude of glycemic excursions(MAGE)
Reflect glucose fluctuation
Time frame: Baseline to 2 weeks
Large amplitude of glycemic excursions (LAGE)
Reflect glucose fluctuation
Time frame: Baseline to 2 weeks
Change in HbA1c from baseline
Reflect 2\~3 months of glycemic control
Time frame: Baseline to 14 weeks
Change in GA(glycosylated albumin)from baseline
Reflect 2\~3 weeks of glycemic control
Time frame: Baseline to 2 weeks
Change in 1,5-anhydroglucitol (1,5-AG) from baseline
Reflect 1\~2 weeks of glycemic control
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 2 weeks
Change in total insulin dose from baseline
Time frame: Baseline to 2 weeks and to 14 weeks
Change in blood lipids from baseline
Time frame: Baseline to 2 weeks and to 14 weeks
Change in body weight from baseline
Time frame: Baseline to 2 weeks and to 14 weeks
Daily mean glucose values
Time frame: Baseline to 2 weeks
Number of participants with severe hypoglycemia and nocturnal hypoglycemia events
Reflects the safety of clinical trials
Time frame: Baseline to 2 weeks and to 14 weeks
Change in Incidence of hypoglycemic events from baseline
Reflects the safety of clinical trials
Time frame: Baseline to 2 weeks and to 14 weeks
Change in gut microbiota from baseline
Time frame: Baseline to 2 weeks and to 14 weeks
Change in metabolomics from baseline
Time frame: Baseline to 2 weeks and to 14 weeks
Change in autoimmunity from baseline
Time frame: Baseline to 14 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.