Overview

Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression

Status:
Recruiting
Trial end date:
2020-09-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cairo University
Treatments:
Captopril
Metformin
Vildagliptin
Criteria
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

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