Intervention for Children With Type 1 Diabetes Targeting Gut Microbes

NCT06198725 | Recruiting

• 1 other identifier: Trimtab-001-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes; High Fiber Diet; Beta-cell function; Gut microbiota

Outcome Measures

Primary Outcomes (1)

• The 2h C-peptide level of the MMTT test

  The 2-hour postprandial C-peptide is detected by the mix meal test. The C peptide level is measured using a sensitive, luminescence immunoassay, accurate to 0.01 ng/ml.

  0 week and 12 weeks

Secondary Outcomes (14)

• Glycosylated hemoglobin level

  0 week, 4 weeks, 12 weeks and 24 weeks

• Glycated albumin level

  0 week, 4 weeks, 12 weeks and 24 weeks

• Fasting C peptide

  0 week, 4 weeks, 12 weeks and 24 weeks

• Daily insulin dosage

  0 week, 4 weeks, 12 weeks and 24 weeks

• Area under curve of blood glucose in MMTT test

  0 week and 12 weeks

Study Arms (2)

High fiber intervention group

EXPERIMENTAL

Participants in the high fiber intervention group take high fiber dietary products (28g dietary fiber per day) for 12 weeks, and at the same time, follow the doctor's advice to use subcutaneous insulin injection for treatment.

Dietary Supplement: Trimtab

Usual treatment group

NO INTERVENTION

Participants in the usual treatment group received routine diet education for diabetes and were treated with subcutaneous insulin injection according to the doctor's advice

Interventions

Trimtab DIETARY_SUPPLEMENT

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.

High fiber intervention group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Adfontes (Shanghai) Bio-technology Co.,Ltd.: collaborator

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Feihong Luo, Dr

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feihong Luo, Dr

CONTACT

86-021-64932107; luofh@fudan.edu.cn

Zhenran Xu, Dr

CONTACT

86-021-64931124; xu_zhenran@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 10, 2024
• Study Start: January 8, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)