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

NCT07172269 | Completed

• 1 other identifier: 92
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Diabetes Mellitus; Diabete Type 2; T2DM; Mangosteen; sitagliptin; metformin; xanthones; antioxidant; inflammation

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c (HbA1c)

  HbA1c level will be measured using an immunoassay method (Roche Cobas c111 system) to assess glycemic control.

  baseline and after 12 weeks

Secondary Outcomes (8)

• Change in HOMA-IR (Insulin Resistance Index)

  baseline and 12 weeks

• Change in Fasting Blood Glucose (FBG)

  Baseline and 12 weeks

• Change in HOMA-B (β-cell Function Index)

  Baseline and 12 weeks

• Change in Lipid Profile (TC, LDL-C, HDL-C, TG, VLDL-C)

  Baseline and 12 weeks

• Change in Serum Interleukin-6 (IL-6)

  Baseline and 12 weeks

Study Arms (2)

Sitagliptin/Metformin + Lifestyle Modification

ACTIVE COMPARATOR

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.

Drug: Sitagliptin + Metformin; Behavioral: Lifestyle Management

Sitagliptin/Metformin + Mangosteen + Lifestyle Modification

EXPERIMENTAL

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.

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

Interventions

Sitagliptin + Metformin DRUG

Oral tablets, 50/1000 mg, taken twice daily after meals for 12 weeks

Also known as: Sitadin M

Sitagliptin/Metformin + Lifestyle Modification; Sitagliptin/Metformin + Mangosteen + Lifestyle Modification

mangosteen supplement DIETARY_SUPPLEMENT

Capsules, 500 mg, taken twice daily after meals for 12 weeks

Also known as: Garcinia mangostana extract

Sitagliptin/Metformin + Mangosteen + Lifestyle Modification

Lifestyle Management BEHAVIORAL

Diabetes education, diet counseling, and exercise guidance provided throughout the 12-week study period.

Sitagliptin/Metformin + Lifestyle Modification; Sitagliptin/Metformin + Mangosteen + Lifestyle Modification

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mais Qais Hbeeb: lead

Study Sites (1)

National Diabetes Center for Treatment and Research

Baghdad, Iraq

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Inflammation

Interventions

Sitagliptin Phosphate; Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Manal Kh Abdulridha, Prof.

  Department of Clinical Pharmacy, College of Pharmacy, Mustansiriyah University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is open-label study, no parties were masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSC Candidate, department of clinical pharmacy , college of pharmacy, Mustansiriyah university, Baghdad, Iraq

Model Details: 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.

Study Record Dates

• First Submitted: September 6, 2025
• First Posted: September 15, 2025
• Study Start: September 15, 2024
• Primary Completion: May 26, 2025
• Study Completion: May 26, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)