Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- Diagnosed as type 1 diabetes for the first time according to the diagnostic criteria of the American diabetes Association (ADA) in the past 6 months;
- One or more antibodies against GAD65, IAA, IA-2, ICA, and ZNT8 are positive;
- The daily total dose of insulin per unit weight was less than 0.5 IU/kg/day three days prior to screening;
- Fasting C-peptide (FCP)\>0.1 nmol/L (0.3ng/mL);
- Age range from 6 to 12 years old;
- Have not participated in any other research projects at present;
- The guardian signs the informed consent form, the child agrees to the study, and the child over 8 years old signs the informed consent form.
Exclusion Criteria:
- Suffering from serious chronic and systemic diseases: tumors, immunodeficiency, heart failure, Cushing's syndrome, kidney diseases (including nephrotic syndrome, nephritis, glomerulonephritis, kidney stones, etc.), liver diseases (including autoimmune hepatitis, metabolic liver disease, non-alcoholic fatty liver disease, primary sclerosing cholangitis, chronic, persistent hepatitis, etc.), gallbladder diseases (including cholecystitis, gallstones, etc.), etc;
- Suffering from acute or chronic gastrointestinal diseases such as Crohn's disease, ulcerative colitis, gastroesophageal reflux disease, gastrointestinal ulcers, celiac disease, or having defecation three or more times a day in the past week or more, accompanied by watery stools;
- Blood pressure ≥ 95th percentile of the same gender, age, and height reference;
- Plasma triglycerides of 9 years and below should be ≥ 1.12mmol/L, and triglycerides of 10 years and above should be ≥ 1.46mmol/L;
- Used antibiotics within the past month for 3 days or more;
- Currently suffering from infectious diseases;
- Have the history of gastrointestinal surgery, surgery to remove appendicitis and hernia;
- Evidence of pituitary dysfunction;
- Use drugs other than insulin that can affect blood sugar levels;
- Chromosomal abnormalities (such as trisomy 21 syndrome, Turner syndrome, etc.);
- Have taken probiotics and probiotic products continuously for more than 3 days within the first month before enrollment;
- Unable to guarantee sufficient time to participate in this project.
