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Trial · NCT07077525

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryEvaluation of HbA1c level0,6 and 12 months of treatment
Measurement of serum levels of HbA1C as a percentage (%) at 0 (baseline) 6 and 12 months. Change of serum level of HbA1C due to treatments after 12 months and determine the frequency of participants achieved reduction of HbA1c level by more than 1%
PrimaryEvaluation of serum level of FBG0, 6 and 12 monthsMeasurement of serum level of FBG as (mg/dl) at 0,6 and 12 months. Change of serum level of FBG due to treatments after 12 months
PrimaryEvaluation of serum level of PPG0.6 and 12 monthsMeasurement of serum level of PPG as (mg/dl) at 0,6 and 12 months. Change of serum level of PPG due to treatments after 12 months
SecondaryEvaluation of Body mass index (BMI)0,6 and 12 months of treatmentChange in body mass index (kg/m2) due to different treatments from baseline to 6, and 12 months.
SecondaryEvaluation of serum inflammatory cytokines0 and 12 months of treatmentAssessment of serum level of interleukin 8 (IL8), nitric oxide (NO) and tumor necrosis factor subtype alpha (TNF-α) at baseline and 12-months post treatment
SecondaryAssessment of genetic variationAfter 12 months of treatment
Genotyping assays among participant of study and its relation to glycemic control and other cardiovascular risk factors for certain genes SNP rs6741949 in the DPP4 gene, SNP rs6923761 in the GLP1 receptor and SNP rs2285676, in the KATP gene.
SecondaryAssessment of lipid profile parameters0, 6 and 12 months of treatmentMeasurement of lipid profile parameters at 0 (baseline) 6 and 12 months. Change of lipid profile parameters due to different treatments from baseline to 12 months of treatment
SecondaryAssessment of a common variant, SNP rs6741949, in the DPP4 geneAfter 12 months of treatmentAssessment of a common variant, SNP rs6741949, in the DPP4 gene to determine the highest frequency and responsive alleles
SecondaryAssessment of a common variant SNP rs6923761, in the GLP1 receptorAfter 12 months of treatmentAssessment of a common variant SNP rs6923761, in the GLP1 receptor to determine the highest frequency and responsive allele.
SecondaryAssessment of a common variant, SNP rs2285676, in the KATP gene.After 12 months of treatmentAssessment of a common variant, SNP rs2285676, in the KATP gene to determine the highest frequency and responsive allele.
OtherMeasurement of homocysteine and vitamin B12 serum levels0 and 12 months. Assessment of homocysteine and vitamin b12 was in serum at 0 and 12 months
OtherMeasurement of stromal cell derived factor and vascular cell adhesion molecule 1 in serum0 and 12 months of treatmentSerum level of stromal cell derived factor 1 alpha (SDF-1α) as a biomarker of CV risk and mortality was determined at 0 and 12 months
OtherEvaluation of serum liver biomarkers0, 6 and 12 months of treatmentSerum liver biomarkers \[alanine aminotransferase (ALT), aspartate aminotransferase (AST), direct and total bilirubin\] will be assessed using standard colorimetric techniques
OtherAssessment of serum creatinine (sCr)0 and 12 months of treatmentMeasurement of serum creatinine (mg/dl) at 0 and 12 months of treatment to determine the change of serum creatinine due to different treatments from baseline to 12 months of treatment
OtherMeasurement of albumin/creatinine ratio0 and 12 months of treatmentMeasurement of albumin/creatinine ratio (mg/g) at 0 and 12 months of treatment to determine the change of A/c ratio due to different treatments from baseline to 12 months of treatment
OtherAssessment of eGFR0 and 12 months of treatmentMeasurement of eGFR (ml/min) at 0 and 12 months of treatment to determine the change of eGFR due to different treatments from baseline to 12 months of treatment
OtherAssessment of CrCl0 and 12 months of treatmentMeasurement of CrCl (ml/min) at 0 and 12 months of treatment to determine the change of CrCl due to different treatments from baseline to 12 months of treatment

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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