Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Insulin Resistance; Hypersensitivity; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The metabolic syndrome is characterized by the presence of overweight/obesity, insulin
      resistance, hyperglycemia, dyslipidaemia and hypertension and an inflammatory state, which
      together increase the risk of developing cardiovascular disease (CVD) or diabetes mellitus
      type 2 (DM2). It is also characterized by a decreased insulin sensitivity, namely, lower
      ability of insulin to metabolize glucose, key in the physiopathogeny of disease process.

      In the search for a pharmacological agent that can attend more components of the metabolic
      syndrome and above all improve insulin sensitivity to effectively prevent the development of
      CVD and DM2, ursolic acid is a promising compound.

      Ursolic acid is a pentacyclic carboxylic acid present in medicinal herbs, parts of some
      fruits like apple peel, and plants such as rosemary. There is scientific evidence of
      important benefits of ursolic acid level in vitro and in vivo on insulin, metabolism of
      lipids and glucose, as well as on the body weight and metabolic parameters. However, the
      results are not clear and the mechanisms are not fully elucidate.

      The aim of this study is to evaluate the effect of ursolic acid on the insulin sensitivity
      and metabolic syndrome.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled clinical trial in 24 patients of both sexes
      aged between 30 and 60 years, with a diagnosis of metabolic syndrome according to the
      modified International Diabetes Federation (IDF) criteria, without treatment.

      They will be assigned randomly two groups of 12 patients, each to receive 150 mg of ursolic
      acid or placebo before breakfast for 12 weeks.

      Insulin sensitivity will be calculated by Matsuda Index with dates from glucose and insulin
      levels from Oral Glucose Tolerance Test; Waist circumference will be measured; triglycerides
      and High density lipoprotein (HDL-C) and blood pressure will be evaluated before and after
      intervention in both groups.

      Statistical analysis will be presented through measures of central tendency and dispersion,
      average and deviation standard for quantitative variables; frequencies and percentages for
      variable qualitative. Qualitative variables will be analyzed by X2, will be used for
      differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups
      differences. Will be considered statistical significance p ≤0.05.

      This protocol was approved by a local ethics committee (CEI/075/2014) and written informed
      consent will be obtained from all volunteers.
    

Intervention name(s): Ursolic acid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast; Calcined magnesia capsules of 150 mg, once a day before breakfast
Other intervention name(s): Urson; Prunol; Micromerol; Malol; Calcined magnesia
Intervention MeSH terms: Ursolic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Metabolic Syndrome; Central Obesity; Insulin Sensitivity; Ursolic Acid; Triterpenoid