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

Mais Qais Hbeeb

Status: Completed

Conditions: Diabete Mellitus; Insulin Resistance; Type 2 Diabetes; Dyslipidemia in Patients With Diabetes Mellitus; Obesity Type 2 Diabetes Mellitus

Treatments: Drug: Sitagliptin + Metformin; Dietary Supplement: mangosteen supplement; Behavioral: Lifestyle Management

Study type: Interventional

Funder types: Other

Identifiers

NCT07172269

92

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Sitagliptin/Metformin + Lifestyle Modification

Active Comparator group

Description:

Patients receive sitagliptin/metformin tablets (50/1000 mg) orally, twice daily for 12 weeks, in addition to lifestyle modification including diet counseling, exercise, and diabetes education.

Treatment:

Behavioral: Lifestyle Management

Drug: Sitagliptin + Metformin

Sitagliptin/Metformin + Mangosteen + Lifestyle Modification

Experimental group

Description:

Patients receive sitagliptin/metformin tablets (50/1000 mg) orally, twice daily, plus mangosteen capsules (500 mg) orally, twice daily for 12 weeks, in addition to lifestyle modification including diet counseling, exercise, and diabetes education.

Treatment:

Behavioral: Lifestyle Management

Dietary Supplement: mangosteen supplement

Drug: Sitagliptin + Metformin