Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-25 @ 8:33 PM
Study NCT ID:
NCT07172269
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2025-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mangosteen Supplement as Adjuvant Therapy With Sitagliptin/Metformin in Iraqi Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is open-label study, no parties were masked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2025-09-06', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hemoglobin A1c (HbA1c)', 'timeFrame': 'baseline and after 12 weeks', 'description': 'HbA1c level will be measured using an immunoassay method (Roche Cobas c111 system) to assess glycemic control.'}], 'secondaryOutcomes': [{'measure': 'Change in HOMA-IR (Insulin Resistance Index)', 'timeFrame': 'baseline and 12 weeks', 'description': 'Calculated using fasting glucose and fasting insulin levels'}, {'measure': 'Change in Fasting Blood Glucose (FBG)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Measured by enzymatic hexokinase method (Roche Cobas c111 analyzer)'}, {'measure': 'Change in HOMA-B (β-cell Function Index)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Calculated using fasting insulin and fasting glucose concentrations'}, {'measure': 'Change in Lipid Profile (TC, LDL-C, HDL-C, TG, VLDL-C)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Measured by enzymatic colorimetric methods (Roche Cobas c111)'}, {'measure': 'Change in Serum Interleukin-6 (IL-6)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Measured by ELISA (sandwich principle)'}, {'measure': 'Change in Serum Superoxide Dismutase-1 (SOD1', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Measured by competitive ELISA kit'}, {'measure': 'Change in Liver Enzymes (AST, ALT, ALP)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Measured by Roche Cobas c111 analyzer'}, {'measure': 'Change in Kidney Function (Serum Creatinine, Urea, and Urinary ACR)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Measured by Roche Cobas c111 analyzer and Combilyzer 13 system'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Diabete Type 2', 'T2DM', 'Mangosteen', 'sitagliptin', 'metformin', 'xanthones', 'antioxidant', 'inflammation'], 'conditions': ['Diabete Mellitus', 'Type 2 Diabetes', 'Obesity Type 2 Diabetes Mellitus', 'Dyslipidemia in Patients With Diabetes Mellitus', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'This clinical trial was conducted at the National Diabetes Center for Treatment and Research, Mustansiriyah University, Baghdad (Sept 2024-May 2025).\n\nIt 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.\n\n* Sample: 47 patients completed the study (22 in sitagliptin/metformin group; 25 in sitagliptin/metformin + mangosteen group).\n* Design: Prospective, randomized, controlled, open-label trial.\n* Intervention: Both groups also received lifestyle modification (diet, exercise, diabetes education).\n* 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.\n* Statistical Analysis: Parametric/non-parametric tests, correlations, regression, and ANCOVA to assess changes and adjust for confounders.', 'detailedDescription': "1. Patients\n\n * Inclusion: Adults (\\>30 years) with T2DM (AACE criteria), HbA1c 7.5-9%.\n * Exclusion: T1DM, insulin users, patients with complications, liver/kidney disease, other metabolic/endocrine disorders, patients on steroids/contraceptives/thyroid meds/supplements, pregnant/lactating women.\n * Ethics: Approved by Mustansiriyah University Ethics Committee. Written informed consent obtained.\n2. Study Design\n\n * Type: Interventional, prospective, randomized, controlled, open-label.\n * Groups:\n * Group 1 (n=22): Sitagliptin/metformin 50/1000 mg twice daily + lifestyle modification.\n * Group 2 (n=25): Sitagliptin/metformin 50/1000 mg twice daily + Mangosteen 500 mg twice daily + lifestyle modification.\n * Duration: 12 weeks.\n * Compliance: Monitored via pill counts, phone follow-ups, monthly clinic visits.\n3. Interventions \\& Protocol\n\n * All patients received standardized diabetes education and counseling.\n * Two-week washout for lipid-lowering drugs before enrollment to avoid confounding.\n * Data collected: demographics, socioeconomic, comorbidities, medication use, family history.\n4. Measurements\n\n * Anthropometry: Weight, height, BMI, waist circumference, index of central obesity (ICO).\n * Samples:\n * Blood: Collected after 12-hour fasting (baseline \\& after 12 weeks). Serum separated for immediate and stored analysis.\n * Urine: Albumin/creatinine ratio to exclude nephropathy.\n * Biochemical tests:\n * Glycemic control: HbA1c (immunoassay), fasting blood glucose (hexokinase method), fasting serum insulin (ECLIA).\n * Insulin resistance \\& β-cell function: HOMA-IR, HOMA-B formulas.\n * Lipid profile: TC, HDL-C, TG, LDL-C, VLDL-C.\n * Inflammatory marker: Interleukin-6 (ELISA).\n * Oxidative stress marker: Superoxide dismutase-1 (ELISA).\n * Kidney function: Serum urea, creatinine, urinary ACR.\n * Liver function: AST, ALT, ALP.\n5. Statistical Analysis\n\n * Software: SPSS v25.\n * Tests Used:\n * Normality: Shapiro-Wilk test.\n * Between-group: Independent t-test or Mann-Whitney U.\n * Within-group: Paired t-test or Wilcoxon signed-rank.\n * Categorical: Chi-square or Fisher's exact.\n * Correlations: Pearson test.\n * Regression: Linear regression for predictors of HbA1c change.\n * ANCOVA: Adjusted analysis for differences between groups (e.g., baseline HOMA-IR).\n * Significance: p \\< 0.05."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged ≥30 years.\n* Diagnosed with Type 2 Diabetes Mellitus according to American Association of Clinical Endocrinologists (AACE) criteria.\n* HbA1c between 7.5% and 9%.\n\nExclusion Criteria:\n\n* T1DM patients were excluded from study.\n* T2DM patients receiving any anti-diabetic treatment other than the study intervention or T2DM patients receiving insulin therapy.\n* Patients with T2DM complications or having liver disease, kidney disease.\n* Patients with other metabolic diseases (thyroid disorders, adrenal disorders, growth hormone disorders and pituitary disorders) that may affect glycemic and metabolic status.\n* Patients receiving drugs (steroids, contraceptives, anticoagulants and thyroid medications) or using other nutritional supplements or herbal remedies that may interfere with lab results.\n* Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT07172269', 'briefTitle': 'Mangosteen Supplement as Adjuvant Therapy With Sitagliptin/Metformin in Iraqi Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Al-Mustansiriyah University'}, 'officialTitle': 'Evaluation the Effect of Mangosteen Supplement as Adjuvant Therapy With Sitagliptin/Metformin in Type 2 Diabetic Iraqi Patients', 'orgStudyIdInfo': {'id': '92'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sitagliptin/Metformin + Lifestyle Modification', '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.', 'interventionNames': ['Drug: Sitagliptin + Metformin', 'Behavioral: Lifestyle Management']}, {'type': 'EXPERIMENTAL', 'label': 'Sitagliptin/Metformin + Mangosteen + Lifestyle Modification', '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.', 'interventionNames': ['Drug: Sitagliptin + Metformin', 'Dietary Supplement: mangosteen supplement', 'Behavioral: Lifestyle Management']}], 'interventions': [{'name': 'Sitagliptin + Metformin', 'type': 'DRUG', 'otherNames': ['Sitadin M'], 'description': 'Oral tablets, 50/1000 mg, taken twice daily after meals for 12 weeks', 'armGroupLabels': ['Sitagliptin/Metformin + Lifestyle Modification', 'Sitagliptin/Metformin + Mangosteen + Lifestyle Modification']}, {'name': 'mangosteen supplement', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Garcinia mangostana extract'], 'description': 'Capsules, 500 mg, taken twice daily after meals for 12 weeks', 'armGroupLabels': ['Sitagliptin/Metformin + Mangosteen + Lifestyle Modification']}, {'name': 'Lifestyle Management', 'type': 'BEHAVIORAL', 'description': 'Diabetes education, diet counseling, and exercise guidance provided throughout the 12-week study period.', 'armGroupLabels': ['Sitagliptin/Metformin + Lifestyle Modification', 'Sitagliptin/Metformin + Mangosteen + Lifestyle Modification']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baghdad', 'country': 'Iraq', 'facility': 'National Diabetes Center for Treatment and Research', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}], 'overallOfficials': [{'name': 'Manal Kh Abdulridha, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Pharmacy, College of Pharmacy, Mustansiriyah University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared. Only aggregated results and statistical analyses will be published in scientific journals or presented at conferences.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mais Qais Hbeeb', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MSC Candidate, department of clinical pharmacy , college of pharmacy, Mustansiriyah university, Baghdad, Iraq', 'investigatorFullName': 'Mais Qais Hbeeb', 'investigatorAffiliation': 'Al-Mustansiriyah University'}}}}