Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression

Study Overview
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Brief Summary
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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
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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

Official Title
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Comparative Effecacy of Metformin and Vildagliptin on Cardiometabolic Risk Factors, Metabolic Syndrome, and Diabetic Nephropathy Progression

Conditions
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Metabolic Syndrome, Diabete Type 2, Kidney Insufficiency

Intervention / Treatment
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* Drug: Vildagliptin
* Drug: Captopril Tablets
* Drug: MetFORMIN 500 Mg Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men or women 40-70 years of age body mass index be-tween≥22 and ≤40 kg/m2. 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 -

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: metformin treated group<br>A group of patients treated with a daily dose of metformin | Drug: Captopril Tablets<br>* used to treat hypertension in metabolic syndrome patients and as a renal protector<br>Drug: MetFORMIN 500 Mg Oral Tablet<br>* antihyperglycemic drug for elevated plasma glucose level and help in weight loss for patients suffering from diabetes or metabolic syndrome<br>|
| Experimental: vildagliptin treated group<br>A group of patients treated with a daily dose of vildagliptin | Drug: Vildagliptin<br>* to compare the effect of both metformin and vildagliptin on the progression of diabetes and metabolic complications and risk factors<br>Drug: Captopril Tablets<br>* used to treat hypertension in metabolic syndrome patients and as a renal protector<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 weeks | 
| estimation of metabolic syndrome deterioration | study the effect of both antidiabetic drugs on blood pressure | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metfomin, vildagliptin, metabolic syndrome, T2DM, nephropathy