Metabolic Syndrome X Clinical Trial
Official title:
Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome
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.
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.
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