A Phase 4 interventional study of Vildagliptin and Captopril Tablets in Metabolic Syndrome, Diabete Type 2 and Kidney Insufficiency, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-07-24.
Sponsored by Cairo University · Phase 4, Interventional, and Treatment
Several crosssectional and prospective studies have shown that metabolic syndrome and its related components are associated with both prevalent and incident CKD .
Although the mechanisms for these cardiovascular benefits of Metformin and vildagliptin remain unclear, they extend well beyond glycemic lowering, and therefore are probably best considered diverse "cardiometabolic" pharmaceuticals rather than simply type 2 diabetes drugs.
Metformin and vildagliptin have known vasculoprotective actions, but the value of these drugs on drug-naïve diabetic patients during 24 week use warrants investigation. The investigator's purpose was to observe their effects on weight control, Cardiometabolic Risk Factors, Metabolic Syndrome risk, and diabetic nephrooathy Progression.
the current study is investigating the relation betweeneach componant of metabolic syndrome and kidney injury incidence or prevalence, and the mechanism of its occurence. the kidney protective effect of metformin and vildagliptin and the mechanism of this action whether it is related to their glucose lowering mechanism or not is also one of the important points to be investigated in the study
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's planned enrollment of 39 is close to the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
(1) pregnant or nursing women; (2) chronic (>7 consecutive days) oral, parenteral or intra-articular corticosteroid treatment within 8 weeks prior to Visit 1 (3) history or evidence of major hepatopathy (aspartate aminotransferase or alanineaminotransferase activities > 2.5 times the upper limit of normal) (4) ischemic heart disease or cerebrovascular disease (5) creatinine level > 0.133 mmol/L (6) major diabetes complications (chronic renal insufficiency, proliferative retinopathy and stroke); (7) extreme dyslipidemia, such as familial hypercholesterolaemia
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A group of patients treated with a daily dose of metformin
Drug: Captopril Tablets · Drug: MetFORMIN 500 Mg Oral Tablet
A group of patients treated with a daily dose of vildagliptin
Drug: Vildagliptin · Drug: Captopril Tablets
to compare the effect of both metformin and vildagliptin on the progression of diabetes and metabolic complications and risk factors
used to treat hypertension in metabolic syndrome patients and as a renal protector
antihyperglycemic drug for elevated plasma glucose level and help in weight loss for patients suffering from diabetes or metabolic syndrome
progression of metabolic syndrome complications
investigate the effect of antidiabetic drugs on improving patients' cases and reduce complcations of metablic syndrome and that will be assessed by measuring glucose serum levels, insulin plasma levels to calculate insulin resistance by HOMA-ir
Time frame: 24 weeks
estimation of metabolic syndrome deterioration
study the effect of both antidiabetic drugs on blood pressure
Time frame: 24 weeks
reduce nephropathic impairement
study the impact of both metformin and vildagliptin on reducing kidney deterioration for patients suffering from metabolic syndrome and that can be assessed by measuring kidney function serologically using ELISA kits for each parameter
Time frame: 24 weeks
Plan to share: No
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Cairo University