Metabolic Syndrome XPhase 2NCT02337933

Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome

A Phase 2 study testing Ursolic acid in people with Metabolic Syndrome X, run by University of Guadalajara at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 30 to 60 years
Conditions the study is for: Metabolic Syndrome X
What is being tested?: Ursolic acid
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteMexico
Study dates: Sep 2014to Sep 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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;

Show all 9Show fewer

Fasting glucose ≥100 mg/dL;
Triglycerides ≥150 mg/dL;
Blood pressure ≥130/85 mmHg

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Instituto de Terapéutica Experimental y Clínica
Guadalajara, Jalisco, 44140

Other trials in Mexico

About this study

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.

Read the detailed description

A randomized, double-blind, placebo-controlled clinical trial in 24 patients of both sexes aged between 30 and 60 years, with a diagnosis of metabolic syndrome according to the modified International Diabetes Federation (IDF) criteria, without treatment.

They will be assigned randomly two groups of 12 patients, each to receive 150 mg of ursolic acid or placebo before breakfast for 12 weeks.

Insulin sensitivity will be calculated by Matsuda Index with dates from glucose and insulin levels from Oral Glucose Tolerance Test; Waist circumference will be measured; triglycerides and High density lipoprotein (HDL-C) and blood pressure will be evaluated before and after intervention in both groups.

Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. Will be considered statistical significance p ≤0.05.

This protocol was approved by a local ethics committee (CEI/075/2014) and written informed consent will be obtained from all volunteers.

Conditions: Metabolic Syndrome X
Being tested: Ursolic acid, Placebo
Keywords: Metabolic Syndrome, Central Obesity, Insulin Sensitivity, Ursolic Acid, Triterpenoid
Medical subject headings: Metabolic Syndrome, Obesity, Abdominal, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ursolic acidDrug
Also called Urson, Prunol, Micromerol, Malol
Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast
PlaceboDrug
Also called Calcined magnesia
Calcined magnesia capsules of 150 mg, once a day before breakfast

Study groups in NCT02337933
Study group	Role	What they receive
Ursolic acid	Experimental	Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks Receives: Drug: Ursolic acid
Placebo	Placebo comparator	Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 12

Secondary outcomes (6)

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
Measured: Week 12
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
Measured: Week 12
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
Measured: Week 12
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
Measured: Week 12
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
Measured: Week 12
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
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Sep 2015

First posted14 Jan 2015 (estimated)
Study startSep 2014
Primary completionSep 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02337933
Sponsor's protocol ID: UA-MS
Status last verified: Sep 2020
First submitted: 9 Jan 2015
Last updated: 8 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 1/2
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Enrolling by invitationEarly Phase 1
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All Metabolic Syndrome X trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome
ClinicalTrials.gov ID: NCT02337933
Acronym / sponsor ID: UA-MS
Conditions: Metabolic Syndrome X
Keywords: Metabolic Syndrome, Central Obesity, Insulin Sensitivity, Ursolic Acid, Triterpenoid
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: University of GuadalajaraUniversity, hospital or other
Study start: Sep 2014 (actual)
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 14 Jan 2015 (estimated)
Results: Posted 8 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this study is to evaluate the effect of ursolic acid on the insulin sensitivity and metabolic syndrome.

Detailed description

They will be assigned randomly two groups of 12 patients, each to receive 150 mg of ursolic acid or placebo before breakfast for 12 weeks.

This protocol was approved by a local ethics committee (CEI/075/2014) and written informed consent will be obtained from all volunteers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Ursolic acid	Experimental	Drug: Ursolic acidUrsolic acid capsules, 150 mg, once a day before breakfast during 12 weeks
Placebo	Placebo comparator	Drug: PlaceboCalcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks

Who may qualify

Ages: 30 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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:

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ursolic acidAlso: Urson, Prunol, Micromerol, MalolUrsolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast	Drug	Ursolic acid
PlaceboAlso: Calcined magnesiaCalcined magnesia capsules of 150 mg, once a day before breakfast	Drug	Placebo

Primary outcome

Total Insulin Sensitivity
Time frame: Week 12
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
Waist Circumference
Time frame: Week 12
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
Fasting Glucose
Time frame: Week 12
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
Triglycerides
Time frame: Week 12
The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12
High Density Lipoprotein Cholesterol (HDL-c)
Time frame: Week 12
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
Systolic Blood Pressure
Time frame: Week 12
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
Diastolic Blood Pressure
Time frame: Week 12
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

6 secondary outcomes

Body Weight
Time frame: Week 12
Body Mass Index
Time frame: Week 12
Total Cholesterol
Time frame: Week 12
Low Density Lipoproteins Cholesterol (LDL-c)
Time frame: Week 12
Creatinine
Time frame: Week 12
Uric Acid
Time frame: Week 12

Results and safety

Results posted to the registry on 8 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ursolic Acid	12	12
Placebo	12	12

Primary outcome: Total Insulin Sensitivity

Time frame: Week 12. Mean (Standard Deviation). Unit: index

Measure	Ursolic Acid n = 12	Placebo n = 12
Value	4.2 (1.2)	2.6 (1.4)

Ursolic Acid vs Placebo: p = 0.003, Wilcoxon (Mann-Whitney)

Primary outcome: Waist Circumference

Time frame: Week 12. Mean (Standard Deviation). Unit: cm

Measure	Ursolic Acid n = 12	Placebo n = 12
Value	83 (9)	96 (8)

Ursolic Acid vs Placebo: p = 0.008, Wilcoxon (Mann-Whitney)

Primary outcome: Fasting Glucose

Time frame: Week 12. Mean (Standard Deviation). Unit: mmol/L

Measure	Ursolic Acid n = 12	Placebo n = 12
Value	4.7 (0.4)	5.7 (0.7)

Ursolic Acid vs Placebo: p = 0.002, Wilcoxon (Mann-Whitney)

Primary outcome: Triglycerides

Time frame: Week 12. Mean (Standard Deviation). Unit: mmol/L

Measure	Ursolic Acid n = 12	Placebo n = 12
Value	1.8 (0.8)	2.5 (1.3)

Ursolic Acid vs Placebo: p = 0.308, Wilcoxon (Mann-Whitney)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the study (12 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ursolic Acid	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
Placebo	0 of 12 (0%)	6 of 12 (50%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Metabolic Syndrome X

Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingPhase 1/2
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
Obesity, Metabolic Syndrome
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Manuel González-Ortíz, PhD principal investigator

University of Guadalajara

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ursolic acid in people with Metabolic Syndrome X, run by University of Guadalajara at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Insulin Sensitivity (time frame: Week 12). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02337933.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.