Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Guadalajara
• Treatments: Insulin; Magnesium Oxide; Ursolic acid

Criteria

Inclusion Criteria:

• Informed consent signed

• Patients both sexes

• Age between 30 and 60 years

• Metabolic Syndrome according to the IDF criteria:

• Waist circumference Man ≥90 cm, Woman ≥80 cm; and two of the following criteria:

• High density lipoprotein Man ≤40 mg/dL, Woman ≤50 mg/dL;

• Fasting glucose ≥100 mg/dL;

• Triglycerides ≥150 mg/dL;

• Blood pressure ≥130/85 mmHg

Exclusion Criteria:

• Women with confirmed or suspected pregnancy

• Women under lactation and/or puerperium

• Hypersensibility to ursolic acid o calcined magnesia

• Physical impossibility for taking pills

• Known uncontrolled renal, hepatic, heart or thyroid diseased

• Previous treatment for the metabolic syndrome components

• Body Mass Index ≥39.9 kg/m2

• Fasting glucose ≥126 mg/dL

• Triglycerides ≥500 mg/dL

• Total cholesterol ≥240 mg/dL

• Low density lipoprotein (c-LDL) ≥190 mg/dL

• Blood Pressure ≥140/90 mmHg