Diabete Mellitus, Dyslipidemia in Patients With Diabetes Mellitus, Insulin Resistance, Obesity Type 2 Diabetes Mellitus, Type 2 Diabetes
Conditions
Keywords
Diabetes Mellitus, Diabete Type 2, T2DM, Mangosteen, sitagliptin, metformin, xanthones, antioxidant, inflammation
Brief 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.
Interventions
Oral tablets, 50/1000 mg, taken twice daily after meals for 12 weeks
DIETARY_SUPPLEMENTmangosteen supplement
Capsules, 500 mg, taken twice daily after meals for 12 weeks
BEHAVIORALLifestyle Management
Diabetes education, diet counseling, and exercise guidance provided throughout the 12-week study period.
Sponsors
Mais Qais Hbeeb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is open-label study, no parties were masked.
Intervention model description
Participants were randomized into two parallel groups. Group 1 received sitagliptin/metformin (50/1000 mg twice daily) plus lifestyle modification. Group 2 received sitagliptin/metformin (50/1000 mg twice daily) plus mangosteen supplement (500 mg twice daily) with lifestyle modification. The intervention period lasted 12 weeks.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c (HbA1c) | baseline and after 12 weeks | HbA1c level will be measured using an immunoassay method (Roche Cobas c111 system) to assess glycemic control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Blood Glucose (FBG) | Baseline and 12 weeks | Measured by enzymatic hexokinase method (Roche Cobas c111 analyzer) |
| Change in HOMA-B (β-cell Function Index) | Baseline and 12 weeks | Calculated using fasting insulin and fasting glucose concentrations |
| Change in Lipid Profile (TC, LDL-C, HDL-C, TG, VLDL-C) | Baseline and 12 weeks | Measured by enzymatic colorimetric methods (Roche Cobas c111) |
| Change in HOMA-IR (Insulin Resistance Index) | baseline and 12 weeks | Calculated using fasting glucose and fasting insulin levels |
| Change in Serum Superoxide Dismutase-1 (SOD1 | Baseline and 12 weeks | Measured by competitive ELISA kit |
| Change in Liver Enzymes (AST, ALT, ALP) | Baseline and 12 weeks | Measured by Roche Cobas c111 analyzer |
| Change in Kidney Function (Serum Creatinine, Urea, and Urinary ACR) | Baseline and 12 weeks | Measured by Roche Cobas c111 analyzer and Combilyzer 13 system |
| Change in Serum Interleukin-6 (IL-6) | Baseline and 12 weeks | Measured by ELISA (sandwich principle) |
Countries
Iraq
Outcome results
None listed