drugset / Trial / NCT07172269

Mangosteen Supplement as Adjuvant Therapy With Sitagliptin/Metformin in Iraqi Patients With Type 2 Diabetes

NCT07172269

Completed 58 enrolled Mais Qais Hbeeb
RandomizedParallel-groupOpen-labelTreatment

Summary

This clinical trial was conducted at the National Diabetes Center for Treatment and Research, Mustansiriyah University, Baghdad (Sept 2024-May 2025). It evaluated the effect of mangosteen supplementation (500 mg twice daily) as an adjunct to sitagliptin/metformin (50/1000 mg twice daily) in newly diagnosed Type 2 Diabetes Mellitus (T2DM) patients over a period of 12 weeks. * Sample: 47 patients completed the study (22 in sitagliptin/metformin group; 25 in sitagliptin/metformin + mangosteen group). * Design: Prospective, randomized, controlled, open-label trial. * Intervention: Both groups also received lifestyle modification (diet, exercise, diabetes education). * Endpoints: Anthropometric measures, glycemic control (FBG, HbA1c, insulin, HOMA-IR, HOMA-B), lipid profile, oxidative stress (SOD1), inflammatory marker (IL-6), liver \& kidney function, and safety monitoring. * Statistical Analysis: Parametric/non-parametric tests, correlations, regression, and ANCOVA to assess changes and adjust for confounders.

Timeline

Start
2024-09-15
Primary completion
2025-05-26
Completion
2025-05-26

Drugs

EvaluationDrugModalityDoseRoute
Background Metformin Small molecule 1000 mg Oral
Background Sitagliptin Small molecule 50 mg Oral