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CompletedNCT07172269

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

Evaluation the Effect of Mangosteen Supplement as Adjuvant Therapy With Sitagliptin/Metformin in Type 2 Diabetic Iraqi Patients

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
58 (actual)
Sponsor
Mais Qais Hbeeb · Academic / Other
Sex
All
Age
30 Years
Healthy volunteers
Not accepted

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.

Detailed description

1. 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. 2. 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. 3. 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. 4. 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. 5. 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.

Conditions

Interventions

TypeNameDescription
DRUGSitagliptin + MetforminOral tablets, 50/1000 mg, taken twice daily after meals for 12 weeks
DIETARY_SUPPLEMENTmangosteen supplementCapsules, 500 mg, taken twice daily after meals for 12 weeks
BEHAVIORALLifestyle ManagementDiabetes education, diet counseling, and exercise guidance provided throughout the 12-week study period.

Timeline

Start date
2024-09-15
Primary completion
2025-05-26
Completion
2025-05-26
First posted
2025-09-15
Last updated
2025-09-15

Locations

1 site across 1 country: Iraq

Source: ClinicalTrials.gov record NCT07172269. Inclusion in this directory is not an endorsement.