Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome

NCT02337933 | Completed Phase 2 Results

• 1 other identifier: UA-MS
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Syndrome X

Keywords

Metabolic Syndrome; Central Obesity; Insulin Sensitivity; Ursolic Acid; Triterpenoid

Outcome Measures

Primary Outcomes (7)

• Total Insulin Sensitivity

  The insulin sensitivity was calculated at baseline and at week 12. The value reported corresponds at week 12 with Matsuda index. Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\]. The entered values reflect the insulin sensitivity

  Week 12

• Waist Circumference

  Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflect the waist circumference measure at week 12

  Week 12

• Fasting Glucose

  The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12

  Week 12

• Triglycerides

  The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12

  Week 12

• High Density Lipoprotein Cholesterol (HDL-c)

  The HDL-c levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12

  Week 12

• Systolic Blood Pressure

  The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12

  Week 12

• Diastolic Blood Pressure

  The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12

  Week 12

Secondary Outcomes (6)

• Body Weight

  Week 12

• Body Mass Index

  Week 12

• Total Cholesterol

  Week 12

• Low Density Lipoproteins Cholesterol (LDL-c)

  Week 12

• Creatinine

  Week 12

Study Arms (2)

Ursolic acid

EXPERIMENTAL

Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks

Drug: Ursolic acid

Placebo

PLACEBO COMPARATOR

Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks

Drug: Placebo

Interventions

Ursolic acid DRUG

Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast

Also known as: Urson, Prunol, Micromerol, Malol

Ursolic acid

Placebo DRUG

Calcined magnesia capsules of 150 mg, once a day before breakfast

Also known as: Calcined magnesia

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Instituto de Terapéutica Experimental y Clínica

Guadalajara, Jalisco, 44140, Mexico

Location

MeSH Terms

Conditions

Metabolic Syndrome; Obesity, Abdominal; Insulin Resistance

Interventions

Ursolic Acid

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pentacyclic Triterpenes; Triterpenes; Terpenes; Hydrocarbons; Organic Chemicals; Sapogenins

Results Point of Contact

• Title: DR. MANUEL GONZALEZ ORTIZ
• Organization: INSTITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA

uiec@prodigy.net.mx

+52 3310585200

Study Officials

• Manuel González-Ortíz, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher Professor

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 14, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 8, 2020
• Results First Posted: October 8, 2020

Record last verified: 2020-09

Locations

ME (1)