Type 1 diabetes
Conditions
Interventions
Placebo group:On the basis of basic medication, daily oral administration of placebo capsules (corn starch) at the same dosage frequency as the experimental group. Other experimental groups.
Sodium Butyrate group:On the basis of basic medication, take 6 600 mg sodium butyrate capsules orally daily, 3 capsules in the morning and 3 capsules with meals in the evening, for 3 months.
Sponsors
Second Xiangya Hospital of CSU
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for diabetes established by the World Health Organization (WHO) in 1999; 2. Positive for at least one of the following islet autoantibodies: glutamic acid decarboxylase autoantibody (GADA), insulinoma associated protein 2 autoantibody (IA-2A), or zinc transporter 8 autoantibody (ZnT8A); 3. Clinically diagnosed with T1D by an endocrinologist; 4. Diagnosed with T1D for less than 1 year; 5. Aged between 18 and 60 years.
Exclusion criteria
Exclusion criteria: 1. Use of any hypoglycemic drugs other than insulin within 1 month prior to randomization; 2. Participation in other clinical trials within 2 months prior to randomization; 3. Use of antibiotics, probiotics, intestinal microecological regulators, or other drugs significantly impacting intestinal flora within 2 months prior to randomization; 4. Gastrointestinal diseases, including celiac disease, irritable bowel syndrome, Crohn's disease, etc.; 5. Serious infections, severe heart, liver, or kidney diseases, tumors, or other inflammatory or autoimmune diseases; 6. Pregnant or lactating women, or women planning to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peripheral TIGIT+ Treg cell frequency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Honeymoon period incidence rate;Changes in pancreatic islet function;Changes in blood glucose control;Changes in gut microbiota;Changes in intestinal and serum metabolites; | — |
Countries
China
Contacts
Public ContactXia Li
Second Xiangya Hospital of CSU
Outcome results
None listed