Mangosteen Supplement as Adjuvant Therapy With Sitagliptin/Metformin in Iraqi Patients With Type 2 Diabetes
Mangosteen Supplement as Adjuvant Therapy With Sitagliptin/Metformin in Iraqi Patients With Type 2 Diabetes
NCT ID: NCT07172269 Phase: NA Status: COMPLETED Enrollment: 58 Completion: 2025-05-26
Conditions
Diabete Mellitus, Type 2 Diabetes, Obesity Type 2 Diabetes Mellitus, Dyslipidemia in Patients With Diabetes Mellitus, Insulin Resistance
Interventions
Sitagliptin + Metformin, mangosteen supplement, Lifestyle Management
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.
Primary Outcome
Change in Hemoglobin A1c (HbA1c)