Metabolic SyndromeNCT01087632
Armolipid Plus and Metabolic Syndrome
A study testing Armolipid Plus in people with Metabolic Syndrome, run by Rottapharm at 1 site in Italy.
Trial summary
Metabolic syndrome is a highly prevalent condition characterized by visceral obesity, abnormalities of glucidic and lipid metabolism, and increased risk for cardiovascular events. Such findings appear to be associated with a decrease in insulin sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Armolipid Plus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2009to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female 18-65 aged, with diagnosis of metabolic syndrome, defined by the presence of waist circumference > 102 cm (M) or >88 cm(F), and two or more of these criteria:
- fasting blood glucose >100 mg;
- systolic blood pressure >135 or diastolic blood pressure >85 mmHg or patients in treatment with antihypertensive drugs;
- triglyceridemia >150 mg/dl;
- HDL cholesterolemia < 40 mg/dl(M), < 50 mg/dl(F).
Who cannot join
- pregnancy
- diabetes mellitus in pharmacologic treatment;
- hepatic failure;
- creatininemia >2 mg/dl;
- triglyceridemia > 500 mg/dl;
- heart failure.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Federico II University - Department of Internal Medicine
Naples, Naples
About this study
Official title: Effects of Armolipid Plus on Indices of Insulin Resistance in Patients With Metabolic Syndrome
Metabolic syndrome is a highly prevalent condition characterized by visceral obesity, abnormalities of glucidic and lipid metabolism, and increased risk for cardiovascular events. Such findings appear to be associated with a decrease in insulin sensitivity. Management of metabolic syndrome is currently aimed at treating individual components of the disease without addressing this underlying pathophysiologic mechanism; this translates into multidrug regimens, high costs and patient compliance issues.
Armolipid Plus (an association of berberine 500 mg, red yeast rice titled in 3 mg monacolin K,policosanol 10 mg,coenzyme Q10 2 mg,astaxanthin 0,5 mg,folic acid 0,2 mg) has been found to be effective at reducing blood cholesterol and triglycerides, and at improving endothelial function; subgroup analyses also suggested a benefit on indices of insulin resistance.
Read more
Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity and on the diagnostic parameters of metabolic syndrome.
60 patients will be enrolled in this randomized, double-blind, placebo-controlled trial; active treatment will consist of Armolipid Plus (1 tbl qd).
Primary end point will be the reduction of the insulin/glucose ratio, both after overnight fast (HOMA index) and after an oral glucose tolerance test (OGTT).
- Conditions
- Metabolic Syndrome
- Being tested
- Armolipid Plus
- Keywords
- Metabolic Syndrome Insulin-resistance Endothelial Function
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Armolipid PlusDietary supplement
Also called berberine, red yeast rice, monacolin K, policosanol
Armolipid Plus 1 tablet QD for 18 weeks
| Study group | Role | What they receive |
|---|---|---|
| Armolipid Plus | Experimental | Armolipid Plus is an association of berberine 500 mg, red yeast rice titled in 3 mg monacolin K,- policosanol 10 mg,coenzyme Q10 2 mg,astaxanthin 0,5 mg,folic acid 0,2 mg Receives: Dietary Supplement: Armolipid Plus |
| Placebo | Placebo comparator | Placebo matching Armolipid plus Receives: Dietary Supplement: Armolipid Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin/glucose ratio after overnight fast
HOMA INDEX
Measured: 18 weeks
Insuline/glucose ratio after an oralglucose tolerance test
OGTT
Measured: 18 weeks
Secondary outcomes (5)
BMI
evaluation of weight and BMI
Measured: 18 weeks
Glycemia
Blood Glucose
Measured: 18 weeks
Endothelial function
endothelial function assessed by Flow Mediated Dilation
Measured: 18 weeks
C reactive protein.
dosage of CRP
Measured: 18 weeks
Serum lipidemia
measure of TG and cholesterol
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startSep 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rottapharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federico II University
- Investigators
- Serafino Fazio, MD, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087632
- Sponsor's protocol ID
- ARMP-09
- Status last verified
- Sep 2010
- First submitted
- 12 Mar 2010
- Last updated
- 2 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Armolipid Plus on Indices of Insulin Resistance in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01087632
- Acronym / sponsor ID
- ARMP-09
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic Syndrome Insulin-resistance Endothelial Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- RottapharmIndustry (pharma, biotech, devices)
- Collaborators
- Federico II University
- Study start
- Sep 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 16 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metabolic syndrome is a highly prevalent condition characterized by visceral obesity, abnormalities of glucidic and lipid metabolism, and increased risk for cardiovascular events. Such findings appear to be associated with a decrease in insulin sensitivity. Management of metabolic syndrome is currently aimed at treating individual components of the disease without addressing this underlying pathophysiologic mechanism; this translates into multidrug regimens, high costs and patient compliance issues.
Armolipid Plus (an association of berberine 500 mg, red yeast rice titled in 3 mg monacolin K,policosanol 10 mg,coenzyme Q10 2 mg,astaxanthin 0,5 mg,folic acid 0,2 mg) has been found to be effective at reducing blood cholesterol and triglycerides, and at improving endothelial function; subgroup analyses also suggested a benefit on indices of insulin resistance.
Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity and on the diagnostic parameters of metabolic syndrome.
60 patients will be enrolled in this randomized, double-blind, placebo-controlled trial; active treatment will consist of Armolipid Plus (1 tbl qd).
Primary end point will be the reduction of the insulin/glucose ratio, both after overnight fast (HOMA index) and after an oral glucose tolerance test (OGTT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Armolipid Plus | Experimental | Dietary Supplement: Armolipid PlusArmolipid Plus is an association of berberine 500 mg, red yeast rice titled in 3 mg monacolin K,- policosanol 10 mg,coenzyme Q10 2 mg,astaxanthin 0,5 mg,folic acid 0,2 mg |
| Placebo | Placebo comparator | Dietary Supplement: Armolipid PlusPlacebo matching Armolipid plus |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and Female 18-65 aged, with diagnosis of metabolic syndrome, defined by the presence of waist circumference > 102 cm (M) or >88 cm(F), and two or more of these criteria:
- fasting blood glucose >100 mg;
- systolic blood pressure >135 or diastolic blood pressure >85 mmHg or patients in treatment with antihypertensive drugs;
- triglyceridemia >150 mg/dl;
- HDL cholesterolemia < 40 mg/dl(M), < 50 mg/dl(F).
Key exclusion criteria (6 listed)
- pregnancy
- diabetes mellitus in pharmacologic treatment;
- hepatic failure;
- creatininemia >2 mg/dl;
- triglyceridemia > 500 mg/dl;
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 |
|---|---|---|
| Armolipid PlusAlso: berberine, red yeast rice, monacolin K, policosanolArmolipid Plus 1 tablet QD for 18 weeks | Dietary supplement | Armolipid Plus, Placebo |
Primary outcome
Insulin/glucose ratio after overnight fast
Time frame: 18 weeks
HOMA INDEX
Insuline/glucose ratio after an oralglucose tolerance test
Time frame: 18 weeks
OGTT
5 secondary outcomes
BMI
Time frame: 18 weeks
Glycemia
Time frame: 18 weeks
Endothelial function
Time frame: 18 weeks
C reactive protein.
Time frame: 18 weeks
Serum lipidemia
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2010.
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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.
Serafino Fazio, MD principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Armolipid Plus in people with Metabolic Syndrome, run by Rottapharm at 1 site in Italy.
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 5 inclusion and 6 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 2 Sep 2010. 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 Italy. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Insulin/glucose ratio after overnight fast (time frame: 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2010.