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| Name | Class |
|---|---|
| Adfontes (Shanghai) Bio-technology Co.,Ltd. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Glycated albumin level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feihong Luo, Dr | Contact | 86-021-64932107 | luofh@fudan.edu.cn | |
| Zhenran Xu, Dr | Contact | 86-021-64931124 | xu_zhenran@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Feihong Luo, Dr | Children's Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
The relevant data can be obtained by applying to the primary investigator
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The levels of glycated albumin is measured by IMMULITE, accurate to 0.1%.
| 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. | 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 | 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. | 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. | 0 week and 12 weeks |
| Adverse event occurrence rate | The incidence of all recorded adverse events | 0 week, 4 weeks, 12 weeks and 24 weeks |
| Body mass index | Body mass index were calculated as weight/(height)^2. | 0 week, 4 weeks, 12 weeks and 24 weeks |
| Height | Height accurate to 0.1cm | 0 week, 4 weeks, 12 weeks and 24 weeks |
| Weight | Weight accurate to 0.1kg | 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. | 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. | 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. | 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. | 0 week, 4 weeks, 12 weeks and 24 weeks |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |