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

• Patients

• Inclusion: Adults (>30 years) with T2DM (AACE criteria), HbA1c 7.5-9%.
• Exclusion: T1DM, insulin users, patients with complications, liver/kidney disease, other metabolic/endocrine disorders, patients on steroids/contraceptives/thyroid meds/supplements, pregnant/lactating women.
• Ethics: Approved by Mustansiriyah University Ethics Committee. Written informed consent obtained.
• Study Design

• Type: Interventional, prospective, randomized, controlled, open-label.
• Groups:
• Group 1 (n=22): Sitagliptin/metformin 50/1000 mg twice daily + lifestyle modification.
• Group 2 (n=25): Sitagliptin/metformin 50/1000 mg twice daily + Mangosteen 500 mg twice daily + lifestyle modification.
• Duration: 12 weeks.
• Compliance: Monitored via pill counts, phone follow-ups, monthly clinic visits.
• Interventions & Protocol

• All patients received standardized diabetes education and counseling.
• Two-week washout for lipid-lowering drugs before enrollment to avoid confounding.
• Data collected: demographics, socioeconomic, comorbidities, medication use, family history.
• Measurements

• Anthropometry: Weight, height, BMI, waist circumference, index of central obesity (ICO).
• Samples:
• Blood: Collected after 12-hour fasting (baseline & after 12 weeks). Serum separated for immediate and stored analysis.
• Urine: Albumin/creatinine ratio to exclude nephropathy.
• Biochemical tests:
• Glycemic control: HbA1c (immunoassay), fasting blood glucose (hexokinase method), fasting serum insulin (ECLIA).
• Insulin resistance & β-cell function: HOMA-IR, HOMA-B formulas.
• Lipid profile: TC, HDL-C, TG, LDL-C, VLDL-C.
• Inflammatory marker: Interleukin-6 (ELISA).
• Oxidative stress marker: Superoxide dismutase-1 (ELISA).
• Kidney function: Serum urea, creatinine, urinary ACR.
• Liver function: AST, ALT, ALP.
• Statistical Analysis

• Software: SPSS v25.
• Tests Used:
• Normality: Shapiro-Wilk test.
• Between-group: Independent t-test or Mann-Whitney U.
• Within-group: Paired t-test or Wilcoxon signed-rank.
• Categorical: Chi-square or Fisher's exact.
• Correlations: Pearson test.
• Regression: Linear regression for predictors of HbA1c change.
• ANCOVA: Adjusted analysis for differences between groups (e.g., baseline HOMA-IR).
• Significance: p < 0.05.

Inclusion criteria

• Adults aged ≥30 years.
• Diagnosed with Type 2 Diabetes Mellitus according to American Association of Clinical Endocrinologists (AACE) criteria.
• HbA1c between 7.5% and 9%.

Exclusion criteria

• T1DM patients were excluded from study.
• T2DM patients receiving any anti-diabetic treatment other than the study intervention or T2DM patients receiving insulin therapy.
• Patients with T2DM complications or having liver disease, kidney disease.
• Patients with other metabolic diseases (thyroid disorders, adrenal disorders, growth hormone disorders and pituitary disorders) that may affect glycemic and metabolic status.
• Patients receiving drugs (steroids, contraceptives, anticoagulants and thyroid medications) or using other nutritional supplements or herbal remedies that may interfere with lab results.
• Pregnant or lactating women.