Metabolic Syndrome X Clinical Trial
Official title:
Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome
NCT number | NCT02337933 |
Other study ID # | UA-MS |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | September 2014 |
Est. completion date | September 2015 |
Verified date | September 2020 |
Source | University of Guadalajara |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto de Terapéutica Experimental y Clínica | Guadalajara | Jalisco |
Lead Sponsor | Collaborator |
---|---|
University of Guadalajara |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 / vglucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity |
Week 12 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Body Weight | The body weight was measured at baseline and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12 | Week 12 | |
Secondary | Body Mass Index | The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12 | Week 12 | |
Secondary | Total Cholesterol | The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12 | Week 12 | |
Secondary | Low Density Lipoproteins Cholesterol (LDL-c) | The LDL-c levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12 | Week 12 | |
Secondary | Creatinine | The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinine levels at week 12 | Week 12 | |
Secondary | Uric Acid | The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12 | Week 12 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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