Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression

Phase 4

• Conditions: Metabolic Syndrome; Diabete Type 2; Kidney Insufficiency
• Interventions: Drug: Captopril Tablets; Drug: Vildagliptin; Drug: MetFORMIN 500 Mg Oral Tablet

• Registration Number: NCT04485845
• Lead Sponsor: Cairo University

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

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2020-03-24
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-21
• Last Update Submitted: 2020-07-21
• Study First Posted: 2020-07-24
• Last Update Posted: 2020-07-24
• Primary Completion: 2020-08-30
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metformin treated group	Captopril Tablets	A group of patients treated with a daily dose of metformin
metformin treated group	MetFORMIN 500 Mg Oral Tablet	A group of patients treated with a daily dose of metformin
vildagliptin treated group	Captopril Tablets	A group of patients treated with a daily dose of vildagliptin
vildagliptin treated group	Vildagliptin	A group of patients treated with a daily dose of vildagliptin

Primary Outcome Measures

Name	Time	Method
estimation of metabolic syndrome deterioration	24 weeks	study the effect of both antidiabetic drugs on blood pressure
progression of metabolic syndrome complications	24 weeks	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

Secondary Outcome Measures

Name	Time	Method
reduce nephropathic impairement	24 weeks	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

Trial Locations

Locations (1)

National Diabetes & Endocrinology Institute; 🇪🇬 Cairo, Egypt