Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-02-24 @ 5:51 AM
Study NCT ID:
NCT07172269
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2025-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mangosteen Supplement as Adjuvant Therapy With Sitagliptin/Metformin in Iraqi Patients With Type 2 Diabetes
Sponsor:
Mais Qais Hbeeb
Organization:
Study Overview
Official Title:
Evaluation the Effect of Mangosteen Supplement as Adjuvant Therapy With Sitagliptin/Metformin in Type 2 Diabetic Iraqi Patients
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: