Combination of Metformine/Inulin Versus Metformin on Prostate Benign Hyperplasia in Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title: Effect of Administration of Combination Metformine/Inulin Versus Metformine on Patients With Prostate Benign Hyperplasia and Metabolic Syndrome Syndrome

Status Completed

Clinical Trial Summary

Type 2 diabetes mellitus, insulin resistance, visceral obesity and disorders of lipid metabolism, especially triglyceride and hypertension are metabolic disorders that play a central role in pathophysiology of metabolic syndrome, and ultimately, the cardiovascular morbidity and mortality associated with atherosclerosis, such as myocardial infarction, cerebral vascular events, vascular dementia, heart failure and end stage renal disease. Recently other complications related with hyperinsulinemia like the prostate benign hypertrophy (BPH). Metformin is the treatment of choice in patients with metabolic syndrome, given its low cost and comparable pharmacological effects to the tiazolinedionas (eg pioglitazone), decreasing hyperinsulinemia, insulin resistance, concentration of free fatty acids and triglycerides, also it produces moderate weight loss, improving the metabolic profile triglcerides atherogenic lipid and carbohydrate and delaying the onset of diabetes mellitus in individuals with impaired fasting glucose.

A second option for risk reduction would be the addition of inulin fiber type as it has been demonstrated some metabolic effects on benefices lipid metabolism and carbohydrate.

It is expected that combination of metformin with inulin produce a beneficial effect through farmacological synergism and the impact on fisiopatological changes of metabolic syndrome that potentially is considered as an important risk factor for prostate growth.

Clinical Trial Description

The main objective is to evaluate the effect of the combination of metformin / inulin on clinical, urodynamic parameters as well as metabolic and inflammatory profile in patients with benign prostate hypertrophy and metabolic syndrome.

The investigators conducted a double-blind trial, randomized, on 4 groups, each group with 15 male and female patients of 40 to 80 years of age with METS diagnosed by IDF criteria and clinical diagnose of HBP. Randomization will determine who will receive the intervention during 12 week trial, each group will be like:

Group (A) intervention with combination metformin/ inulin: 15 individuals recieved combination of metformin/ agave inulin in a dosis of 500 mg / 10 grs per 24hrs during 12 weeks.

Group (B) Metformin plus Placebo of agave inulin: 15 individuals recieved Metformin in a dosis of 500mg per day (with the first bite of the second meal) plus homologue placebo of agave inulin (calcinated magnesia) in a dosis of 10grs each 24 hrs during 12 weeks.

Group (C) agave inulin plus placebo of Metformin: 15 indivuduals recieved agave inulin in a dosis of 10grs per 24hrs plus homologate placebo of metformin (calcinated magnesia) in a dosis of 500 mg per day (with the first bite of the second meal) during 12 weeks.

Group (D) Placebo of agave inulin plus Placebo of Metformin: homologate placebo of agave inulin (calcinated magnesia) in a dosis of 10 grs each 24 hrs plus homologate placebo of metformin (calcinated magnesia capsules) in a dosis of 500 mg per day (with the first bite of the second meal) during 12 weeks.

The clinical findings and laboratory test include a metabolic profile and biosafety, will be baseline and at 12 weeks.

Clinical components of Mets like antropometrics parameters, fasting glucose, fasting insulin, blood lipids, clinical finding of HBP and inflammation parameters and adipocitocins, IGF-1, insulin, prostatic specific antigen. Adverse events and adherence to treatment will be documented. Statistical analysis: Mann-Whitney U Test and Wilcoxon exact test. It is considered with significance at p<0.05. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperplasia
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

• NCT number: NCT02778776
• Study type: Interventional
• Source: Centro Universitario de Ciencias de la Salud, Mexico
• Status: Completed
• Phase: Phase 3
• Start date: January 2013
• Completion date: June 2015