The Effect of Sea Buckthorn Extract in Patients With Type 1 Diabetes

The Effect of Sea Buckthorn Extract in Patients With Type 1 Diabetes

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.

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.