Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression

NCT ID: NCT04485845

Last Updated: 2020-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-09-30

Brief Summary

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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

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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

Conditions

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Metabolic Syndrome Diabete Type 2 Kidney Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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metformin treated group

A group of patients treated with a daily dose of metformin

Group Type ACTIVE_COMPARATOR

Captopril Tablets

Intervention Type DRUG

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

MetFORMIN 500 Mg Oral Tablet

Intervention Type DRUG

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

vildagliptin treated group

A group of patients treated with a daily dose of vildagliptin

Group Type EXPERIMENTAL

Vildagliptin

Intervention Type DRUG

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

Captopril Tablets

Intervention Type DRUG

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

Interventions

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Vildagliptin

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

Intervention Type DRUG

Captopril Tablets

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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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Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Dalia K. Zaafar

lecturer of pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dalia Zaafar, PhD

Role: PRINCIPAL_INVESTIGATOR

Lecturer of clinical pharmacology and toxicology

Locations

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National Diabetes & Endocrinology Institute

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Dalia Zaafar, PhD

Role: CONTACT

00201117922833

soha hassanin, PhD

Role: CONTACT

Facility Contacts

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dalia zaafar, phd

Role: primary

soha hassanin, phd

Role: backup

Other Identifiers

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IDE00218

Identifier Type: -

Identifier Source: org_study_id

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