The goal of this clinical study is to evaluate the effect of nutritional intervention program based on dietary products in the clinical treatment of newly diagnosed children with type 1 diabetes. The main question aims to answer is: whether high fiber diet can protect beta-cell function in children with newly onset type 1 diabetes. Participants will take 12 weeks of high fiber diet intervention and beta-cell function and gut microbiota structure will be analyzed.
The purpose of this project is to establish an early adjuvant treatment program for children with type 1 diabetes targeting gut microbiome, and to evaluate the clinical effect and safety of a dietary product to protect the beta-cell function of newly diagnosed type 1 diabetes children and improve blood sugar control. Plan to adopt the parallel randomized controlled clinical trial method to select newly-diagnosed type 1 diabetes children, and randomly divide them into Usual care group and High fiber diet group at a ratio of 1:1. To comprehensively evaluate the clinical effect and long-term effect of a high fiber dietary intervention product, the changes of beta-cell function, glucose metabolism, and the structure and function of gut microbiota will be compared before and after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
High fiber group will take Trimtab (a kind of multi bran and high fiber grain compound powder) 60g per day to intake 28g dietary fiber for 12 weeks.
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGThe 2h C-peptide level of the MMTT test
The 2-hour postprandial C-peptide is detected by the mix meal test. The C peptide level is measured using a sensitive, luminescence immunoassay, accurate to 0.01 ng/ml.
Time frame: 0 week and 12 weeks
Glycosylated hemoglobin level
The levels of glycosylated hemoglobin is detection by high performance liquid chromatography. Accurate to 0.1%.
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
Glycated albumin level
The levels of glycated albumin is measured by IMMULITE, accurate to 0.1%.
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
Fasting C peptide
The level of fasting C peptide is measured using a sensitive, luminescence immunoassay, accurate to 0.01 ng/ml.
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
Daily insulin dosage
The daily insulin dosage used per kilogram of body weight. IU/kg/d
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
Area under curve of blood glucose in MMTT test
The level of blood glucose will be tested at 0 min, 30 min, 60 min and 120 min of the mix meal test, and the area under curve will be calculated.
Time frame: 0 week and 12 weeks
Area under curve of C peptide in MMTT test
The level of C peptide will be tested at 0 min, 30 min, 60 min and 120 min of the mix meal test, and the area under curve will be calculated.
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Time frame: 0 week and 12 weeks
Adverse event occurrence rate
The incidence of all recorded adverse events
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
Body mass index
Body mass index were calculated as weight/(height)\^2.
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
Height
Height accurate to 0.1cm
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
Weight
Weight accurate to 0.1kg
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
alanine aminotransferase
The level of alanine aminotransferaseis is measured by enzymatic method. Accurate to 0.01 u/l.
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
aspartate aminotransferase
The level of aspartate aminotransferase is measured by enzymatic method. Accurate to 0.01 u/l.
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
Total cholesterol
The level of total cholesterol is measured by enzymatic method. Accurate to 0.01 mmol/L.
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
Triglyceride
The level of triglyceride is measured by enzymatic method. Accurate to 0.01 mmol/L.
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks