Dietary intervention for children with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the effects of a high fiber diet on beta-cell function in newly diagnosed children with type 1 diabetes. Participants will undergo a 12-week dietary intervention, with their beta-cell function and gut microbiota analyzed before and after the treatment. The study employs a parallel randomized controlled trial design, comparing a usual care group to a high fiber diet group to assess the clinical effects and safety of the dietary intervention.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Feihong Luo, Dr — Children's Hospital of Fudan University
• Study coordinator: Feihong Luo, Dr
• Email: luofh@fudan.edu.cn
• Phone: 86-021-64932107

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.