Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression

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

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.

Study Overview

• Status: Unknown
• Conditions: Metabolic Syndrome; Kidney Insufficiency; Diabete Type 2
• Intervention / Treatment: Drug: Captopril Tablets; Drug: MetFORMIN 500 Mg Oral Tablet; Drug: Vildagliptin

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 Type: Interventional
• Enrollment (Anticipated): 39
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dalia Zaafar, PhD; Phone Number: 00201117922833; Email: dalia.zaffar@pharm.mti.edu.eg
• Study Contact Backup: Name: soha hassanin, phd; Email: phsoha@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11311
    • Recruiting
    • National Diabetes & Endocrinology Institute
    • Contact: dalia zaafar, phd
    • Contact: soha hassanin, phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Captopril Tablets; used to treat hypertension in metabolic syndrome patients and as a renal protector; Drug: Vildagliptin; to compare the effect of both metformin and vildagliptin on the progression of diabetes and metabolic complications and risk factors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 weeks
estimation of metabolic syndrome deterioration	study the effect of both antidiabetic drugs on blood pressure	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Dalia Zaafar, PhD, Lecturer of clinical pharmacology and toxicology

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): August 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: T2DM; metabolic syndrome; vildagliptin; nephropathy; metfomin
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Disease; Diabetes Mellitus; Insulin Resistance; Hyperinsulinism; Diabetes Mellitus, Type 2; Syndrome; Metabolic Syndrome; Renal Insufficiency; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Angiotensin-Converting Enzyme Inhibitors; Metformin; Vildagliptin; Captopril
• Other Study ID Numbers: IDE00218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No