Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Kidney Insufficiency; Metabolic Syndrome; Diabete Type 2

Treatments: Drug: Vildagliptin; Drug: Captopril Tablets; Drug: MetFORMIN 500 Mg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04485845

IDE00218

Details and patient eligibility

About

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.

Full 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

Enrollment: 39 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

39 participants in 2 patient groups

metformin treated group

Active Comparator group

Description:

A group of patients treated with a daily dose of metformin

Treatment:

Drug: MetFORMIN 500 Mg Oral Tablet

Drug: Captopril Tablets

vildagliptin treated group

Experimental group

Description:

A group of patients treated with a daily dose of vildagliptin

Treatment:

Drug: Captopril Tablets

Drug: Vildagliptin