Type 1 Diabetes
Conditions
Keywords
Sea buckthorn extract, type 1 diabetes, T cell, islet β-cell, glucose metabolism
Brief summary
Type 1 diabetes (T1D) is an autoimmune disease characterized by the destruction of insulin-producing β-cells by autoreactive T cells. Sea buckthorn (SBT), a traditional Chinese medicine homologous to food, confers beneficial effects on the autoimmune system. Whether SBT regulates the glucose metabolism and immune microenvironment in T1D remains unknown. This study aims to investigate the impact of SBT on glycemic control and T-cell balance in patients with T1D. Patients with T1D consumed 10g of SBT extracts daily for 12 weeks. Clinical and experimental data were analyzed at the baseline and after 12 weeks of SBT treatment. Healthy controls were enrolled with no treatment. Side adverse effects will be recorded in this study.
Interventions
DIETARY_SUPPLEMENTSea buckthorn
Sea buckthorn extract One of the differences between these two studies and ours is that the SBT used in our study is extracted by supercritical extraction technology without additional components.
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients diagnosed with Type 1 Diabetes Mellitus (T1DM) by an endocrinologist at a qualified medical institution. * Aged between 18 and 75 years (inclusive). * Maintained a stable anti-diabetic medication regimen for at least 3 months prior to enrollment and is expected to remain stable throughout the study duration. * Glycated Hemoglobin A1c (HbA1c) ≤ 8%.
Exclusion criteria
* Patients with other types of diabetes (including Type 2 Diabetes, monogenic diabetes, diseases of the exocrine pancreas, and drug- or chemical-induced diabetes). * History of acute metabolic events, specifically Diabetic Ketoacidosis (DKA) or Hyperosmolar Hyperglycemic State (HHS), within the past 6 months. * Current use of medications that may affect immune function, including immunomodulatory or immunosuppressive treatment, steroids, or antibiotics in the previous 3 months. * Pregnant or lactating women. * Patients with abnormal renal function or abnormal liver function. * Patients with malignant diseases. * Patients with acute or chronic infection. * Patients with a history of psychiatric or neurological disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose control | From enrollment to the end of treatment at 12 weeks. | To investigate the effect of SBT on glucose metabolism in patients, fasting glucose level in mmol/L were measured after patients with T1D were administered a daily oral dose of 10g of SBT for 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| T-cell population | From enrollment to the end of treatment at 12 weeks. | Fresh whole blood specimens were collected from patients with T1DM. T cell populations were analyzed on the flow cytometry. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXiaoyan Chen, Doctor
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed