Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02337933
• Date of registration: 09/01/2015
• Prospective Registration: No
• Primary sponsor: University of Guadalajara
• Public title: Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome
• Scientific title: Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome
• Date of first enrolment: September 2014
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02337933
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Mexico

Contacts

• Name: Manuel González-Ortíz, PhD
• Affiliation: University of Guadalajara

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Metabolic Syndrome X

Intervention(s)

Drug: Ursolic acid

Drug: Placebo

Primary Outcome(s)

Systolic Blood Pressure [Time Frame: Week 12]

Triglycerides [Time Frame: Week 12]

Waist Circumference [Time Frame: Week 12]

Fasting Glucose [Time Frame: Week 12]

High Density Lipoprotein Cholesterol (HDL-c) [Time Frame: Week 12]

Total Insulin Sensitivity [Time Frame: Week 12]

Diastolic Blood Pressure [Time Frame: Week 12]

Secondary Outcome(s)

Low Density Lipoproteins Cholesterol (LDL-c) [Time Frame: Week 12]

Creatinine [Time Frame: Week 12]

Total Cholesterol [Time Frame: Week 12]

Uric Acid [Time Frame: Week 12]

Body Mass Index [Time Frame: Week 12]

Body Weight [Time Frame: Week 12]

Secondary ID(s)

UA-MS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02337933