Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04485845

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome Diabete Type 2 Kidney Insufficiency	Drug: Vildagliptin Drug: Captopril Tablets Drug: MetFORMIN 500 Mg Oral Tablet	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2019

Anticipated Primary Completion Date :

Aug 30, 2020

Anticipated Study Completion Date :

Sep 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: metformin treated group A group of patients treated with a daily dose of metformin	Drug: Captopril Tablets used to treat hypertension in metabolic syndrome patients and as a renal protector Drug: 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
Experimental: vildagliptin treated group A group of patients treated with a daily dose of vildagliptin	Drug: Vildagliptin to compare the effect of both metformin and vildagliptin on the progression of diabetes and metabolic complications and risk factors Drug: Captopril Tablets used to treat hypertension in metabolic syndrome patients and as a renal protector

Arm

Intervention/Treatment

Active Comparator: metformin treated group

A group of patients treated with a daily dose of metformin

Drug: Captopril Tablets

used to treat hypertension in metabolic syndrome patients and as a renal protector

Drug: 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

Experimental: vildagliptin treated group

A group of patients treated with a daily dose of vildagliptin

Drug: Vildagliptin

to compare the effect of both metformin and vildagliptin on the progression of diabetes and metabolic complications and risk factors

Drug: Captopril Tablets

used to treat hypertension in metabolic syndrome patients and as a renal protector

Outcome Measures

Primary Outcome Measures

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
estimation of metabolic syndrome deterioration [24 weeks]
study the effect of both antidiabetic drugs on blood pressure

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

men or women 40-70 years of age
body mass index be-tween≥22 and ≤40 kg/m2.
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