Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression

Last updated: July 21, 2020
Sponsor: Cairo University
Overall Status: Active - Recruiting

Phase

4

Condition

Metabolic Disorders

High Cholesterol (Hyperlipidemia)

Nephropathy

Treatment

N/A

Clinical Study ID

NCT04485845
IDE00218
  • Ages 40-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

(1) pregnant or nursing women; (2) chronic (>7 consecutive days) oral, parenteral orintra-articular corticosteroid treatment within 8 weeks prior to Visit 1 (3) history orevidence of major hepatopathy (aspartate aminotransferase or alanineaminotransferaseactivities > 2.5 times the upper limit of normal) (4) ischemic heart disease orcerebrovascular disease (5) creatinine level > 0.133 mmol/L (6) major diabetescomplications (chronic renal insufficiency, proliferative retinopathy and stroke); (7)extreme dyslipidemia, such as familial hypercholesterolaemia

Study Design

Total Participants: 39
Study Start date:
November 01, 2019
Estimated Completion Date:
September 30, 2020

Study 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

Connect with a study center

  • National Diabetes & Endocrinology Institute

    Cairo, 11311
    Egypt

    Active - Recruiting

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