Phase 2
Completed N=24
Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome
Metabolic Syndrome X
Source: ClinicalTrials.gov NCT02337933 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Total Insulin Sensitivity — 4.2; 2.6 index — p=0.003
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Insulin Sensitivity |
4.2; 2.6 | 0.003 sig |
| PRIMARY Waist Circumference |
83; 96 | 0.008 sig |
| PRIMARY Fasting Glucose |
4.7; 5.7 | 0.002 sig |
| PRIMARY Triglycerides |
1.8; 2.5 | 0.308 |
| PRIMARY High Density Lipoprotein Cholesterol (HDL-c) |
1.8; 1.8 | 0.575 |
| PRIMARY Systolic Blood Pressure |
120; 124 | 0.169 |
| PRIMARY Diastolic Blood Pressure |
76; 76 | 0.373 |
| SECONDARY Body Weight |
71; 81 | 0.002 sig |
| SECONDARY Body Mass Index |
24.9; 32.1 | 0.049 sig |
| SECONDARY Total Cholesterol |
5.2; 6.4 | 0.224 |
| SECONDARY Low Density Lipoproteins Cholesterol (LDL-c) |
2.8; 4.3 | 0.116 |
| SECONDARY Creatinine |
0.06; 0.06 | 0.953 |
| SECONDARY Uric Acid |
249.8; 422.3 | 0.999 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02337933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.