Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression

NCT04485845 | Unknown Phase 4 DMC

• 1 other identifier: IDE00218
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Diabete Type 2; Kidney Insufficiency

Keywords

metfomin; vildagliptin; metabolic syndrome; T2DM; nephropathy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• reduce nephropathic impairement

  24 weeks

Study Arms (2)

metformin treated group

ACTIVE COMPARATOR

A group of patients treated with a daily dose of metformin

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

vildagliptin treated group

EXPERIMENTAL

A group of patients treated with a daily dose of vildagliptin

Drug: Vildagliptin; Drug: Captopril Tablets

Interventions

Vildagliptin DRUG

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

vildagliptin treated group

Captopril Tablets DRUG

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

metformin treated group; vildagliptin treated group

MetFORMIN 500 Mg Oral Tablet DRUG

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

metformin treated group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men or women 40-70 years of age
• body mass index be-tween≥22 and ≤40 kg/m2.
• DM with an HbA1c ≥ 7

You may not qualify if:

• (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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

National Diabetes & Endocrinology Institute

Cairo, 11311, Egypt

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus, Type 2; Renal Insufficiency; Kidney Diseases

Interventions

Vildagliptin; Captopril; Metformin; Tablets

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Dalia Zaafar, PhD

  Lecturer of clinical pharmacology and toxicology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dalia Zaafar, PhD

CONTACT

00201117922833; dalia.zaffar@pharm.mti.edu.eg

soha hassanin, PhD

CONTACT

phsoha@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of pharmacology

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: July 24, 2020
• Study Start: November 1, 2019
• Primary Completion: August 30, 2020
• Study Completion: September 30, 2020
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)