Combination of Metformine/Inulin Versus Metformin on Prostate Benign Hyperplasia in Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome; Hyperplasia
Study type: Interventional
Phase: Phase 3

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.
    

Detailed 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.
    

Intervention name(s): Metformin; Agave inulin; Placebo of agave inulin; Metformin placebo
Intervention type(s): Drug; Dietary Supplement; Other; Other
Intervention description(s): Metfomin in tablet presentation of 500 mg; Oligofructan in powder obtained from agave plant, it was given to each patient a full 10 mg container.; Calcinated magnesia powder; Calcinated magnesia tablet
Other intervention name(s): GLUCOPHAGE
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Metformin; Agave Inulin; METS; Inflammation parameters; Urodynamic parameters; Prostate hyperplasia