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Diabete MellitusNCT07172269

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

A study testing Sitagliptin + Metformin, mangosteen supplement and Lifestyle Management in people with Diabete Mellitus and Type 2 Diabetes, run by Mais Qais Hbeeb at 1 site in Iraq.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 years and older
What is being tested?
Sitagliptin + Metformin, mangosteen supplement and Lifestyle Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteIraq
Study dates
15 Sep 2024to 26 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Iraq1 site

  • National Diabetes Center for Treatment and Research

    Baghdad

Other trials in Iraq

About this study

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

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.
Read the 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
Being tested
Sitagliptin + Metformin, mangosteen supplement, Lifestyle Management
Keywords
Diabetes Mellitus, Diabete Type 2, T2DM, Mangosteen, sitagliptin, metformin, xanthones, antioxidant, inflammation
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2, Insulin Resistance, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sitagliptin + MetforminDrug

    Also called Sitadin M

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

  • mangosteen supplementDietary supplement

    Also called Garcinia mangostana extract

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

  • Lifestyle ManagementBehavioural

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

Study groups in NCT07172269
Study groupRoleWhat they receive
Sitagliptin/Metformin + Lifestyle ModificationActive comparatorPatients 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.
Receives: Drug: Sitagliptin + Metformin; Behavioral: Lifestyle Management
Sitagliptin/Metformin + Mangosteen + Lifestyle ModificationExperimentalPatients 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.
Receives: Drug: Sitagliptin + Metformin; Dietary Supplement: mangosteen supplement; Behavioral: Lifestyle Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Hemoglobin A1c (HbA1c)

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

    Measured: baseline and after 12 weeks

Secondary outcomes (8)

  1. Change in HOMA-IR (Insulin Resistance Index)

    Calculated using fasting glucose and fasting insulin levels

    Measured: baseline and 12 weeks

  2. Change in Fasting Blood Glucose (FBG)

    Measured by enzymatic hexokinase method (Roche Cobas c111 analyzer)

    Measured: Baseline and 12 weeks

  3. Change in HOMA-B (β-cell Function Index)

    Calculated using fasting insulin and fasting glucose concentrations

    Measured: Baseline and 12 weeks

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

    Measured by enzymatic colorimetric methods (Roche Cobas c111)

    Measured: Baseline and 12 weeks

  5. Change in Serum Interleukin-6 (IL-6)

    Measured by ELISA (sandwich principle)

    Measured: Baseline and 12 weeks

  6. Change in Serum Superoxide Dismutase-1 (SOD1

    Measured by competitive ELISA kit

    Measured: Baseline and 12 weeks

  7. Change in Liver Enzymes (AST, ALT, ALP)

    Measured by Roche Cobas c111 analyzer

    Measured: Baseline and 12 weeks

  8. Change in Kidney Function (Serum Creatinine, Urea, and Urinary ACR)

    Measured by Roche Cobas c111 analyzer and Combilyzer 13 system

    Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2025
  2. Study start15 Sep 2024
  3. Primary completion26 May 2025
  4. Study completion26 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07172269
Sponsor's protocol ID
92
Status last verified
Sep 2025
First submitted
6 Sep 2025
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared. Only aggregated results and statistical analyses will be published in scientific journals or presented at conferences.

Questions about this trial

What is this clinical trial studying?

A study testing Sitagliptin + Metformin, mangosteen supplement and Lifestyle Management in people with Diabete Mellitus and Type 2 Diabetes, run by Mais Qais Hbeeb at 1 site in Iraq.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hemoglobin A1c (HbA1c) (time frame: baseline and after 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07172269.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

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