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Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression

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ClinicalTrials.gov Identifier: NCT04485845
Recruitment Status : Unknown
Verified July 2020 by Dalia K. Zaafar, Cairo University.
Recruitment status was:  Recruiting
First Posted : July 24, 2020
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Dalia K. Zaafar, Cairo University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 1, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. progression of metabolic syndrome complications [ Time Frame: 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

  2. estimation of metabolic syndrome deterioration [ Time Frame: 24 weeks ]
    study the effect of both antidiabetic drugs on blood pressure


Secondary Outcome Measures :
  1. reduce nephropathic impairement [ Time Frame: 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
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04485845


Contacts
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Contact: Dalia Zaafar, PhD 00201117922833 dalia.zaffar@pharm.mti.edu.eg
Contact: soha hassanin, PhD phsoha@hotmail.com

Locations
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Egypt
National Diabetes & Endocrinology Institute Recruiting
Cairo, Egypt, 11311
Contact: dalia zaafar, phd         
Contact: soha hassanin, phd         
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Dalia Zaafar, PhD Lecturer of clinical pharmacology and toxicology
More Information
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Responsible Party: Dalia K. Zaafar, lecturer of pharmacology, Cairo University
ClinicalTrials.gov Identifier: NCT04485845    
Other Study ID Numbers: IDE00218
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dalia K. Zaafar, Cairo University:
metfomin
vildagliptin
metabolic syndrome
T2DM
nephropathy
Additional relevant MeSH terms:
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Renal Insufficiency
Metabolic Syndrome
Diabetes Mellitus, Type 2
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Kidney Diseases
 Urologic Diseases
Metformin
Vildagliptin
Captopril
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents