Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression

Cairo University39 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metabolic Syndrome Diabete Type 2

Interventions

VildagliptinDRUG

to compare the effect of both metformin and vildagliptin on the progression of diabetes and metabolic complications and risk factors

Captopril TabletsDRUG

used to treat hypertension in metabolic syndrome patients and as a renal protector

MetFORMIN 500 Mg Oral TabletDRUG

antihyperglycemic drug for elevated plasma glucose level and help in weight loss for patients suffering from diabetes or metabolic syndrome

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. men or women 40-70 years of age 2. body mass index be-tween≥22 and ≤40 kg/m2. 3. 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 \-

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts