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Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression

Primary Purpose

Metabolic Syndrome, Diabete Type 2, Kidney Insufficiency

Status

Unknown status

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Vildagliptin

Captopril Tablets

MetFORMIN 500 Mg Oral Tablet

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring metfomin, vildagliptin, metabolic syndrome, T2DM, nephropathy

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

National Diabetes & Endocrinology InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

metformin treated group

vildagliptin treated group

Arm Description

A group of patients treated with a daily dose of metformin

A group of patients treated with a daily dose of vildagliptin

Outcomes

Primary Outcome Measures

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

estimation of metabolic syndrome deterioration

study the effect of both antidiabetic drugs on blood pressure

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04485845

First Posted

March 24, 2020

Last Updated

July 21, 2020

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04485845

Brief Title

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

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

August 30, 2020 (Anticipated)

Study Completion Date

September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome, Diabete Type 2, Kidney Insufficiency

Keywords

metfomin, vildagliptin, metabolic syndrome, T2DM, nephropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

metformin treated group

Arm Type

Active Comparator

Arm Description

A group of patients treated with a daily dose of metformin

Arm Title

vildagliptin treated group

Arm Type

Experimental

Arm Description

A group of patients treated with a daily dose of vildagliptin

Intervention Type

Drug

Intervention Name(s)

Vildagliptin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Captopril Tablets

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

MetFORMIN 500 Mg Oral Tablet

Intervention Description

antihyperglycemic drug for elevated plasma glucose level and help in weight loss for patients suffering from diabetes or metabolic syndrome

Primary Outcome Measure Information:

Title

progression of metabolic syndrome complications

Description

Time Frame

24 weeks

Title

estimation of metabolic syndrome deterioration

Description

study the effect of both antidiabetic drugs on blood pressure

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

reduce nephropathic impairement

Description

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dalia Zaafar, PhD

Phone

00201117922833

dalia.zaffar@pharm.mti.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

soha hassanin, PhD

phsoha@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dalia Zaafar, PhD

Organizational Affiliation

Lecturer of clinical pharmacology and toxicology

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Diabetes & Endocrinology Institute

City

Cairo

ZIP/Postal Code

11311

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

dalia zaafar, phd

First Name & Middle Initial & Last Name & Degree

soha hassanin, phd

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression

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