Clinical trial NCT04485845: Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression
Official title: Comparative Effecacy of Metformin and Vildagliptin on Cardiometabolic Risk Factors, Metabolic Syndrome, and Diabetic Nephropathy Progression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Metabolic Syndrome
Diabete Type 2
Kidney Insufficiency
Keywords: metfomin
vildagliptin
metabolic syndrome
T2DM
nephropathy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 39
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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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Primary outcomes:
measure: progression of metabolic syndrome complications
timeFrame: 24 weeks
measure: estimation of metabolic syndrome deterioration
timeFrame: 24 weeks
Secondary outcomes:
measure: reduce nephropathic impairement
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Diabetes & Endocrinology Institute
Study officials:
affiliation: Lecturer of clinical pharmacology and toxicology
name: Dalia Zaafar, PhD
role: PRINCIPAL_INVESTIGATOR
References: