Combination of Metformine/Inulin Versus Metformin on Prostate Benign Hyperplasia in Metabolic Syndrome
Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Centro Universitario de Ciencias de la Salud, Mexico