Intervention for Children With Type 1 Diabetes Targeting Gut Microbes

Type 1 Diabetes Clinical Trial

— TRIM1  

Official title:

Intervention for Children With Type 1 Diabetes Targeting Gut Microbes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06198725
• Other study ID #: Trimtab-001-01
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Children's Hospital of Fudan University
• Contact: Feihong Luo, Dr
• Phone: 86-021-64932107
• Email: luofh[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Adfontes (Shanghai) Bio-technology Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Glycosylated hemoglobin level	The levels of glycosylated hemoglobin is detection by high performance liquid chromatography. Accurate to 0.1%.	0 week, 4 weeks, 12 weeks and 24 weeks
Secondary	Glycated albumin level	The levels of glycated albumin is measured by IMMULITE, accurate to 0.1%.	0 week, 4 weeks, 12 weeks and 24 weeks
Secondary	Fasting C peptide	The level of fasting C peptide is measured using a sensitive, luminescence immunoassay, accurate to 0.01 ng/ml.	0 week, 4 weeks, 12 weeks and 24 weeks
Secondary	Daily insulin dosage	The daily insulin dosage used per kilogram of body weight. IU/kg/d	0 week, 4 weeks, 12 weeks and 24 weeks
Secondary	Area under curve of blood glucose in MMTT test	The level of blood glucose will be tested at 0 min, 30 min, 60 min and 120 min of the mix meal test, and the area under curve will be calculated.	0 week and 12 weeks
Secondary	Area under curve of C peptide in MMTT test	The level of C peptide will be tested at 0 min, 30 min, 60 min and 120 min of the mix meal test, and the area under curve will be calculated.	0 week and 12 weeks
Secondary	Adverse event occurrence rate	The incidence of all recorded adverse events	0 week, 4 weeks, 12 weeks and 24 weeks
Secondary	Body mass index	Body mass index were calculated as weight/(height)^2.	0 week, 4 weeks, 12 weeks and 24 weeks
Secondary	Height	Height accurate to 0.1cm	0 week, 4 weeks, 12 weeks and 24 weeks
Secondary	Weight	Weight accurate to 0.1kg	0 week, 4 weeks, 12 weeks and 24 weeks
Secondary	alanine aminotransferase	The level of alanine aminotransferaseis is measured by enzymatic method. Accurate to 0.01 u/l.	0 week, 4 weeks, 12 weeks and 24 weeks
Secondary	aspartate aminotransferase	The level of aspartate aminotransferase is measured by enzymatic method. Accurate to 0.01 u/l.	0 week, 4 weeks, 12 weeks and 24 weeks
Secondary	Total cholesterol	The level of total cholesterol is measured by enzymatic method. Accurate to 0.01 mmol/L.	0 week, 4 weeks, 12 weeks and 24 weeks
Secondary	Triglyceride	The level of triglyceride is measured by enzymatic method. Accurate to 0.01 mmol/L.	0 week, 4 weeks, 12 weeks and 24 weeks