Type 1 DiabetesTRIM1NCT06198725
Intervention for Children With Type 1 Diabetes Targeting Gut Microbes
A study testing Trimtab in people with Type 1 Diabetes, run by Children's Hospital of Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Trimtab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality
Luo Feihong, +862164931226 ext. +862164931226, luofh@fudan.edu.cn
Xu Zhenran, +862164931226 ext. +862164931226, xu_zhenran@fudan.edu.cn
About this study
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.
Read the detailed 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Trimtab
- Keywords
- Type 1 Diabetes, High Fiber Diet, Beta-cell function, Gut microbiota
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrimtabDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 week and 12 weeks
Secondary outcomes (14)
Glycosylated hemoglobin level
The levels of glycosylated hemoglobin is detection by high performance liquid chromatography. Accurate to 0.1%.
Measured: 0 week, 4 weeks, 12 weeks and 24 weeks
Glycated albumin level
The levels of glycated albumin is measured by IMMULITE, accurate to 0.1%.
Measured: 0 week, 4 weeks, 12 weeks and 24 weeks
Fasting C peptide
The level of fasting C peptide is measured using a sensitive, luminescence immunoassay, accurate to 0.01 ng/ml.
Measured: 0 week, 4 weeks, 12 weeks and 24 weeks
Daily insulin dosage
The daily insulin dosage used per kilogram of body weight. IU/kg/d
Measured: 0 week, 4 weeks, 12 weeks and 24 weeks
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.
Measured: 0 week and 12 weeks
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.
Measured: 0 week and 12 weeks
Adverse event occurrence rate
The incidence of all recorded adverse events
Measured: 0 week, 4 weeks, 12 weeks and 24 weeks
Body mass index
Body mass index were calculated as weight/(height)^2.
Measured: 0 week, 4 weeks, 12 weeks and 24 weeks
Height
Height accurate to 0.1cm
Measured: 0 week, 4 weeks, 12 weeks and 24 weeks
Weight
Weight accurate to 0.1kg
Measured: 0 week, 4 weeks, 12 weeks and 24 weeks
alanine aminotransferase
The level of alanine aminotransferaseis is measured by enzymatic method. Accurate to 0.01 u/l.
Measured: 0 week, 4 weeks, 12 weeks and 24 weeks
aspartate aminotransferase
The level of aspartate aminotransferase is measured by enzymatic method. Accurate to 0.01 u/l.
Measured: 0 week, 4 weeks, 12 weeks and 24 weeks
Total cholesterol
The level of total cholesterol is measured by enzymatic method. Accurate to 0.01 mmol/L.
Measured: 0 week, 4 weeks, 12 weeks and 24 weeks
Triglyceride
The level of triglyceride is measured by enzymatic method. Accurate to 0.01 mmol/L.
Measured: 0 week, 4 weeks, 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start8 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Adfontes (Shanghai) Bio-technology Co.,Ltd.
- Responsible party
- Sponsor
- Investigators
- Feihong Luo, Dr, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198725
- Sponsor's protocol ID
- Trimtab-001-01
- Acronym
- TRIM1
- Status last verified
- Mar 2026
- First submitted
- 27 Dec 2023
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The relevant data can be obtained by applying to the primary investigator
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Children With Type 1 Diabetes Targeting Gut Microbes
- ClinicalTrials.gov ID
- NCT06198725
- Acronym / sponsor ID
- TRIM1 / Trimtab-001-01
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, High Fiber Diet, Beta-cell function, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Adfontes (Shanghai) Bio-technology Co.,Ltd.
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fiber intervention group | Experimental | Dietary Supplement: TrimtabParticipants 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. |
| 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 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrimtabHigh 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. | Dietary supplement | High fiber intervention group |
Primary outcome
The 2h C-peptide level of the MMTT test
Time frame: 0 week and 12 weeks
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.
14 secondary outcomes
Glycosylated hemoglobin level
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
Glycated albumin level
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
Fasting C peptide
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
Daily insulin dosage
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
Area under curve of blood glucose in MMTT test
Time frame: 0 week and 12 weeks
Area under curve of C peptide in MMTT test
Time frame: 0 week and 12 weeks
Adverse event occurrence rate
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
Body mass index
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
Height
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
Weight
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
alanine aminotransferase
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
aspartate aminotransferase
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
Total cholesterol
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
Triglyceride
Time frame: 0 week, 4 weeks, 12 weeks and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No. The relevant data can be obtained by applying to the primary investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feihong Luo, Dr principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trimtab in people with Type 1 Diabetes, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feihong Luo, Dr (86-021-64932107, luofh@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 2h C-peptide level of the MMTT test (time frame: 0 week and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.