Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression

Metabolic Syndrome Clinical Trial

Official title:

Comparative Effecacy of Metformin and Vildagliptin on Cardiometabolic Risk Factors, Metabolic Syndrome, and Diabetic Nephropathy Progression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04485845
• Other study ID #: IDE00218
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: July 2020
• Source: Cairo University
• Contact: Dalia Zaafar, PhD
• Phone: 00201117922833
• Email: dalia.zaffar[@]pharm.mti.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: September 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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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Related Conditions & MeSH terms

• Diabete Type 2
• Diabetes Mellitus, Type 2
• Kidney Insufficiency
• Metabolic Syndrome
• Renal Insufficiency
• Syndrome

Intervention

Drug:
• Vildagliptin
to compare the effect of both metformin and vildagliptin on the progression of diabetes and metabolic complications and risk factors
• Captopril Tablets
used to treat hypertension in metabolic syndrome patients and as a renal protector
• MetFORMIN 500 Mg Oral Tablet
antihyperglycemic drug for elevated plasma glucose level and help in weight loss for patients suffering from diabetes or metabolic syndrome

Locations

Country	Name	City	State
Egypt	National Diabetes & Endocrinology Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 weeks
Primary	estimation of metabolic syndrome deterioration	study the effect of both antidiabetic drugs on blood pressure	24 weeks
Secondary	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	24 weeks