Intervention for Children With Type 1 Diabetes Targeting Gut Microbes

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 12
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Children's Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Feihong Luo, Dr
luofh@fudan.edu.cn
86-021-64932107
Backup
Zhenran Xu, Dr
xu_zhenran@163.com
86-021-64931124
Time Frame
Start Date: 2024-01-08
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 110
Treatments
Experimental: High fiber intervention group
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.
No_intervention: Usual treatment group
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
Related Therapeutic Areas
Sponsors
Collaborators: Adfontes (Shanghai) Bio-technology Co.,Ltd.
Leads: Children's Hospital of Fudan University

This content was sourced from clinicaltrials.gov