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

Launched by CENTRO UNIVERSITARIO DE CIENCIAS DE LA SALUD, MEXICO · May 19, 2016

Keywords

ClinConnect Summary

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...

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of metabolic syndrome by IDF criteria
• * a person to be defined as having the metabolic syndrome they must have: Central obesity (defined as waist circumference\* with ethnicity specific values) ≥80 cm in females and ≥90 cm in males; and plus any two of the following four factors:
• • Raised triglycerides ≥ 150 mg/dL (1.7 mmol/L) or specific treatment for this lipid abnormality Reduced HDL cholesterol
• • \< 40 mg/dL (1.03 mmol/L) in males \< 50 mg/dL (1.29 mmol/L) in females or specific treatment for this lipid abnormality
• • Raised blood pressure systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg or treatment of previously diagnosed hypertension
• • Raised fasting plasma glucose (FPG) ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes
• • Age ranging from 40 to 80 years old
• • Male patients
• • Informed written consent
• Exclusion Criteria:
• • Kidney disease
• • Hepatic disease
• • Thyroid disease
• • Diabetes mellitus
• • Ischemic heart disease
• • Drug consumption
• • Alcohol consumption of more than 2 ounces daily
• • Consumption of drugs that intervene with lipid or glucose metabolism 2 months before
• • Blood pressure \>160/100mmHg.
• • Lack of adherence to treatment (adherence \<80%)