Study of Personalized Combination Treatment to Regenerate the Thymus and Improve Immune Health in Adults Aged 40 to 80

What this Trial Is About

Researchers are evaluating a personalized combination treatment to regenerate the thymus, an immune system organ that declines with age, in this expanded pilot clinical study called the TRIIM-X trial. The goal is to potentially prevent or reverse aspects of immune aging and other aging processes by studying biomarkers of epigenetic aging and immunosenescence. The study also monitors clinical measures and risk factors related to frailty, cancer, cardiovascular disease, diabetes, dementia, and infections like flu and COVID-19. The treatment involves personalized doses of recombinant human growth hormone somatropin combined with metformin and DHEA, similar to an earlier TRIIM trial that showed promising effects. Participants are assigned either to this combination treatment or an active control group receiving metformin and DHEA. The treatment lasts for 12 months, during which researchers evaluate the effects on thymus regeneration and aging biomarkers. Participants will be involved in a 12-month study with regular monitoring to assess epigenetic age, thymus regeneration, safety, tolerability, and immunosenescence. The study uses randomized assignment and single masking. Researchers will collect data on biomarkers and clinical outcomes, ensuring adherence and safety throughout. The trial aims to gather information to develop an effective personalized treatment for a broader population.

Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial