Comparative Effecacy of Metformin and Vildagliptin on Cardiometabolic Risk Factors, Metabolic Syndrome, and Diabetic Nephropathy Progression
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Cairo University
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- estimation of metabolic syndrome deterioration
Study Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •men or women 40-70 years of age
- •body mass index be-tween≥22 and ≤40 kg/m
- •DM with an HbA1c ≥ 7
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
Arms & Interventions
metformin treated group
A group of patients treated with a daily dose of metformin
Intervention: Captopril Tablets (Drug)
metformin treated group
A group of patients treated with a daily dose of metformin
Intervention: MetFORMIN 500 Mg Oral Tablet (Drug)
vildagliptin treated group
A group of patients treated with a daily dose of vildagliptin
Intervention: Vildagliptin (Drug)
vildagliptin treated group
A group of patients treated with a daily dose of vildagliptin
Intervention: Captopril Tablets (Drug)
Outcomes
Primary Outcomes
estimation of metabolic syndrome deterioration
Time Frame: 24 weeks
study the effect of both antidiabetic drugs on blood pressure
progression of metabolic syndrome complications
Time Frame: 24 weeks
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
Secondary Outcomes
- reduce nephropathic impairement(24 weeks)
Investigators
Dalia K. Zaafar
lecturer of pharmacology
Cairo University