A Pilot Study of Berberine (Soloways ™) in Patients with Type 2 Diabetes Mellitus Carrying TCF7L2 Polymorphisms

Inclusion Criteria: * Adults (age 30-70 years) with a confirmed diagnosis of type 2 diabetes mellitus. * On stable doses of metformin or other standard oral antihyperglycemic agents for at least 4 weeks prior to enrollment. * Willingness to undergo genetic testing for TCF7L2 polymorphisms. For the Homozygous Variant Cohort: confirmed homozygous high-risk TCF7L2 polymorphism (e.g., rs7903146) prior to enrollment. * For the Non-Variant Cohort: confirmed wild-type TCF7L2 genotype. Exclusion Criteria: * Current use of insulin therapy or recent (within 4 weeks) change in diabetic medications. Known hypersensitivity or intolerance to berberine or related compounds. * Significant renal or hepatic impairment. * Pregnancy or breastfeeding. * Any other acute or chronic condition that, in the investigator's judgment, could compromise the patient's safety or the study's integrity.