Clinical Research Directory

Fecal Microbiota Transplantation for Type 2 Diabetes Mellitus and Hashimoto's Thyroiditis

The goal of this clinical trial is to learn if fecal microbiota transplantation (FMT) can improve metabolic control and immune function in adults with both type 2 diabetes and Hashimoto's thyroiditis (an autoimmune thyroid disease). It will also learn about the safety of FMT in these patients. The main questions it aims to answer are: Can FMT lower blood sugar levels (HbA1c, fasting blood glucose, and 2-hour post-meal blood glucose) in participants with type 2 diabetes? Can FMT reduce thyroid autoantibody levels (TPOAb and TgAb) in participants with Hashimoto's thyroiditis? This is a single-arm study, meaning all participants will receive the same FMT treatment. Researchers will compare each participant's results before and after the intervention to see if FMT has an effect. Participants will: Complete baseline tests including blood work and stool sample collection during the 2-week screening period Take 40 oral FMT capsules by mouth over about 1.5 hours under medical supervision at the start of the study Keep taking their usual diabetes and thyroid medications at the same dose throughout the study, unless their doctor says otherwise Return for follow-up visits and tests at 12 weeks and 24 weeks after the FMT treatment

Risk Assessment of Pancreatic Islet Autoimmunity in Patients With AITD

This study aims to evaluate the risk of islet autoimmunity in patients with autoimmune thyroid disease (AITD), describe related clinical and laboratory characteristics, and explore the development of a risk assessment model based on clinical, laboratory, and genetic markers. Adults aged 18-60 years with confirmed AITD will undergo baseline assessment including demographic data, anthropometric measures, lifestyle factors, medical history, thyroid-related clinical information, thyroid function, and thyroid antibody testing. A baseline blood sample will be collected for measurement of islet autoantibodies (GADA, IA-2A, ZnT8A, and IAA). Participants with positive islet autoantibodies will undergo further evaluation of glucose metabolism and beta-cell function, including HbA1c, OGTT, insulin, and C-peptide testing. Genome-wide genetic data will be used to construct a type 1 diabetes-related genetic risk score, and additional HLA genotyping may be performed in autoantibody-positive participants. The study will assess the prevalence and profile of islet autoantibodies in AITD and identify clinical, laboratory, and genetic factors associated with islet autoantibody positivity.

Changes in Natural Immunity in Pregnant Women With Autoimmune Thyroid Disease

Autoimmune thyroid disease (AITD) is the most common endocrine disorder in women of reproductive age, including during pregnancy. It encompasses two clinical conditions: autoimmune hyperthyroidism and hypothyroidism. Pregnancy significantly affects thyroid function regulation, while thyroid dysfunction can influence fertility, pregnancy progression, and the postpartum health. Although the role of acquired immunity in AITD is well understood, recent research increasingly emphasizes innate immunity. Key cells involved in innate immunity include neutrophils, monocytes, and NKT cells. However, limited data exist on their role during pregnancy, especially in women with AITD. This study aims to investigate the dynamic changes in neutrophils, monocytes and NKT cells during pregnancy and compare findings between women with normal pregnancies and those with AITD. The study will analyze the frequency and activation status of these innate immune cells in peripheral blood samples collected during the first, second, and third trimesters. In addition, concentrations of thyrotropin, thyroid hormones, thyroglobulin, and thyroid autoantibodies, will be measured. A thyroid ultrasound will also be performed.