Clinical trial NCT06198725: Intervention for Children With Type 1 Diabetes Targeting Gut Microbes
Official title: Intervention for Children With Type 1 Diabetes Targeting Gut Microbes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes
High Fiber Diet
Beta-cell function
Gut microbiota
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Adfontes (Shanghai) Bio-technology Co.,Ltd.
First posted: 2024-01-10
Enrollment: 110
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 criteria: 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.

Primary outcomes:
measure: The 2h C-peptide level of the MMTT test
timeFrame: 0 week and 12 weeks
Secondary outcomes:
measure: Glycosylated hemoglobin level
timeFrame: 0 week, 4 weeks, 12 weeks and 24 weeks
measure: Glycated albumin level
timeFrame: 0 week, 4 weeks, 12 weeks and 24 weeks
measure: Fasting C peptide
timeFrame: 0 week, 4 weeks, 12 weeks and 24 weeks
measure: Daily insulin dosage
timeFrame: 0 week, 4 weeks, 12 weeks and 24 weeks
measure: Area under curve of blood glucose in MMTT test
timeFrame: 0 week and 12 weeks
measure: Area under curve of C peptide in MMTT test
timeFrame: 0 week and 12 weeks
measure: Adverse event occurrence rate
timeFrame: 0 week, 4 weeks, 12 weeks and 24 weeks
measure: Body mass index
timeFrame: 0 week, 4 weeks, 12 weeks and 24 weeks
measure: Height
timeFrame: 0 week, 4 weeks, 12 weeks and 24 weeks
measure: Weight
timeFrame: 0 week, 4 weeks, 12 weeks and 24 weeks
measure: alanine aminotransferase
timeFrame: 0 week, 4 weeks, 12 weeks and 24 weeks
measure: aspartate aminotransferase
timeFrame: 0 week, 4 weeks, 12 weeks and 24 weeks
measure: Total cholesterol
timeFrame: 0 week, 4 weeks, 12 weeks and 24 weeks
measure: Triglyceride
timeFrame: 0 week, 4 weeks, 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Feihong Luo, Dr
role: PRINCIPAL_INVESTIGATOR
References: