Intervention for Children With Type 1 Diabetes Targeting Gut Microbes
ConditionType 1 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorChildren's Hospital of Fudan University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Trimtab
Dietary supplementHigh 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: High fiber intervention groupExperimental treatment 1 intervention
Group B: Usual treatment groupNo intervention 0 interventions
Trial outcomes
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.
Time frame
0 week and 12 weeksSecondary outcomes
1
Glycosylated hemoglobin level
The levels of glycosylated hemoglobin is detection by high performance liquid chromatography. Accurate to 0.1%.
Time frame
0 week, 4 weeks, 12 weeks and 24 weeks2
Glycated albumin level
The levels of glycated albumin is measured by IMMULITE, accurate to 0.1%.
Time frame
0 week, 4 weeks, 12 weeks and 24 weeks3
Fasting C peptide
The level of fasting C peptide is measured using a sensitive, luminescence immunoassay, accurate to 0.01 ng/ml.
Time frame
0 week, 4 weeks, 12 weeks and 24 weeks4
Daily insulin dosage
The daily insulin dosage used per kilogram of body weight. IU/kg/d
Time frame
0 week, 4 weeks, 12 weeks and 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Fudan University
Lead sponsor
Adfontes (Shanghai) Bio-technology Co.,Ltd.
Collaborator
Source ClinicalTrials.gov