Dietary intervention for children with type 1 diabetes

Intervention for Children With Type 1 Diabetes Targeting Gut Microbes

This study tests if a high fiber diet can help newly diagnosed children with type 1 diabetes have better beta-cell function over 12 weeks compared to those who follow their usual care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 6 Years to 12 Years
• Sex: All
• Sponsor: Children's Hospital of Fudan University (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06198725 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 to 12 years who have been newly diagnosed with type 1 diabetes within the past 6 months.

Not a fit: Patients with serious chronic diseases or those who have participated in other research projects may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could help preserve beta-cell function and improve blood sugar control in children with type 1 diabetes.

How similar studies have performed: While dietary interventions in diabetes management have been explored, this specific approach targeting gut microbiota in children with type 1 diabetes is relatively novel.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• 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

Conditions: Type 1 Diabetes, High Fiber Diet, Beta-cell function, Gut microbiota