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

NCT07172269 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-09-15

No results posted yet for this study

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

Interventions

DRUG

Sitagliptin + Metformin

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

DIETARY_SUPPLEMENT

mangosteen supplement

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

BEHAVIORAL

Lifestyle Management

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

Sponsors & Collaborators

  • Mais Qais Hbeeb

    lead OTHER

Principal Investigators

  • Manal Kh Abdulridha, Prof. · Department of Clinical Pharmacy, College of Pharmacy, Mustansiriyah University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-15
Primary Completion
2025-05-26
Completion
2025-05-26

Countries

  • Iraq

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07172269 on ClinicalTrials.gov