Type 1 Diabetes
Conditions
Interventions
Placebo group:Oral corn starch capsules
Sodium Cholate group:Sodium Cholate Capsules
Sponsors
Second Xiangya Hospital of CSU
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Meet the 1999 World Health Organization (WHO) diagnostic criteria for diabetes; 2. Positive for at least one islet autoantibody (GADA, IA-2A, or ZnT8A); 3. Clinically diagnosed with type 1 diabetes (T1D) by an endocrinologist; 4. With a T1D duration of less than one year; 5. Aged 18-60 years.
Exclusion criteria
Exclusion criteria: 1. Use of any glucose-lowering medications other than insulin within 1 month prior to randomization; 2. Participation in any other clinical trial within 2 months prior to randomization; 3. Use of antibiotics, probiotic preparations, intestinal microecological regulators, or other drugs known to significantly affect gut microbiota within 2 months prior to randomizatio; 4. Gastrointestinal diseases including celiac disease, irritable bowel syndrome, Crohn's disease, etc; 5. Severe infections, severe cardiac, hepatic, or renal diseases, malignancies, 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 CD226+ CD8T cell frequency; | — |
Secondary
| Measure | Time frame |
|---|---|
| islet function; | — |
Countries
China
Contacts
Public ContactXia Li
Second Xiangya Hospital of CSU
Outcome results
None listed