Intervention for Children With Type 1 Diabetes Targeting Gut Microbes

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.

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.

Interventions

• Dietary supplement Trimtab
  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.

Primary outcome measures

• The 2h C-peptide level of the MMTT test [Time frame: 0 week and 12 weeks]

Secondary outcome measures (12)

• Glycosylated hemoglobin level [Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks]
• Glycated albumin level [Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks]
• Fasting C peptide [Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks]
• Daily insulin dosage [Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks]
• Area under curve of blood glucose in MMTT test [Time frame: 0 week and 12 weeks]
• Area under curve of C peptide in MMTT test [Time frame: 0 week and 12 weeks]
• Adverse event occurrence rate [Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks]
• Body mass index [Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks]
• Height [Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks]
• Weight [Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks]
• alanine aminotransferase [Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks]
• aspartate aminotransferase [Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Children's Hospital of Fudan University — Shanghai

Identifiers

NCT: NCT06198725 · Trimtab-001-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗