Metabolic SyndromeARMP-11NCT02295176
Metabolic and Cardiovascular Effects of Armolipid Plus in Subjects With Metabolic Syndrome
A study testing Armolipid Plus in people with Metabolic Syndrome and Insulin-resistance, run by Rottapharm at 3 sites in Italy.
Trial summary
Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity in patients with MetS and increased LV mass. 168 patients will be enrolled in this randomized, double-blind, parallel-group, placebo-controlled trial and treated for 24 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Syndrome, Insulin-resistance, Left Ventricular Hypertrophy
- 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
- 159 participants
- Where
- 3 sitesItaly
- Study dates
- Apr 2013to Jul 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and Female 18-70 aged, with diagnosis of metabolic syndrome, defined by the presence of waist circumference >102 cm (♂) or >88 cm(♀), 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).
- left ventricular hypertrophy: left ventricular mass indexed to height >44 g/m2,7(♀)or >48 g/m2(♂).
- antihypertensive and lipid-lowering therapy (if applicaple) stable for at least three months.
- ability to understand and sign an informed consent form.
Who cannot join
- pregnancy or lactation period
- diabetes mellitus or pharmacological treatment for this condition
- hepatic failure
- creatininemia >2mg/dl
- triglyceridemia >500mg/dl
- severe obesity (BMI >35)
Show all 18Show fewer
- chronic renal failure with glomerular filtration rate <30ml/min
- triglycerides >500mg/dl
- left ventricular systolic dysfunction (LVEF <40%)
- hypertrophic cardiomyopathy
- valvular stenosis
- previous myocardial infarction with acinesie
- intermediate or severe cardiac valve disorders
- intolerance to any components of Armolipid Plus
- pacemaker generated arrhythmia
- Inadequately controlled high blood pressure during therapy optimization (SBP >140mmHg or DBP >90mmHg)
- patients with comorbidities are allowed (e.g. ischemic heart disease, dysthyroidism) but they have got to be in stable therapy for at least 3 months and they did not have major clinical events in the last three months;
- heart failure.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Domenico Bonaduce
Naples, Naples, 80131
Ferruccio Galletti
Naples
Giuseppe Schillaci
Terni
About this study
Official title: Metabolic and Cardiovascular Effects of a Proprietary Nutraceutical Containing Berberine, Policosanols and Red Yeast in Subjects With Metabolic Syndrome
Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity in patients with MetS and increased LV mass.
168 patients will be enrolled in this randomized, double-blind, parallel-group, placebo-controlled trial and treated for 24 weeks.
Read the detailed description
Metabolic syndrome (MetS) 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.
A complication of hypertension is hypertrophy of the left ventricle (LV), which is closely related to the incidence of cardiovascular events whose regression results in a proportional reduction of the risk. But also other factors contribute as sex, age, race, genetics, diet and insulin resistance.
MetS is closely related to hypertrophy of the LV. Therefore it is possible that the treatment of MetS may be an effective strategy for the prevention of organ damage.
Armolipid Plus (an association of berberine 500mg, red yeast rice titled in 3 mg monacolin K,- policosanol 10 mg, coenzyme Q10 2mg,astaxanthin 0,5mg, folic acid 0,2mg) has been found to be effective at reducing blood cholesterol and triglycerides, and at improving endothelial function; subgroup analyses also suggested a benefit on glucose metabolism, myocardial mass and improved diastolic function in subjects with MetS and early organ damage.
Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity in patients with MetS and increased LV mass.
168 patients will be enrolled in this randomized, double-blind, parallel-group, placebo-controlled trial; active treatment will consist of Armolipid Plus (1 tbl qd).
Primary end point will be the reduction of the insulin resistance in patients with metabolic syndrome and increased LV mass.
- Being tested
- Armolipid Plus, Placebo
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Armolipid PlusDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Armolipid Plus | Experimental | Armolipid Plus: 1 tablet daily in the evening after dinner for 24 weeks. Receives: Dietary Supplement: Armolipid Plus |
| Placebo | Placebo comparator | 1 tablet matching Armolipid Plus daily in the evening after dinner for 24 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure will be the reduction of the insulin/glucose ratio, both after overnight fast (HOMA index)
Measured: 6 months
Secondary outcomes (1)
cardiac remodeling assessed by echocardiogram, lipid profile, subtypes of LDL, blood pressure, and high-sensitivity C-reactive protein.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startApr 2013
- Primary completionMar 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rottapharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295176
- Sponsor's protocol ID
- ARMP-11
- Acronym
- ARMP-11
- Status last verified
- Oct 2015
- First submitted
- 5 Nov 2014
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mercurio V, Pucci G, Bosso G, Fazio V, Battista F, Iannuzzi A, Brambilla N, Vitalini C, D'Amato M, Giacovelli G, Vaudo G, Schillaci G, Galletti F, Bonaduce D. A nutraceutical combination reduces left ventricular mass in subjects with metabolic syndrome and left ventricular hypertrophy: A multicenter, randomized, double-blind, placebo-controlled trial. Clin Nutr. 2020 May;39(5):1379-1384. doi: 10.1016/j.clnu.2019.06.026. Epub 2019 Jul 19.
PubMed 31371114
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Cardiovascular Effects of a Proprietary Nutraceutical Containing Berberine, Policosanols and Red Yeast in Subjects With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02295176
- Acronym / sponsor ID
- ARMP-11 / ARMP-11
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- RottapharmIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 20 Nov 2014 (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.
Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity in patients with MetS and increased LV mass.
168 patients will be enrolled in this randomized, double-blind, parallel-group, placebo-controlled trial and treated for 24 weeks.
Detailed description
Metabolic syndrome (MetS) 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.
A complication of hypertension is hypertrophy of the left ventricle (LV), which is closely related to the incidence of cardiovascular events whose regression results in a proportional reduction of the risk. But also other factors contribute as sex, age, race, genetics, diet and insulin resistance.
MetS is closely related to hypertrophy of the LV. Therefore it is possible that the treatment of MetS may be an effective strategy for the prevention of organ damage.
Armolipid Plus (an association of berberine 500mg, red yeast rice titled in 3 mg monacolin K,- policosanol 10 mg, coenzyme Q10 2mg,astaxanthin 0,5mg, folic acid 0,2mg) has been found to be effective at reducing blood cholesterol and triglycerides, and at improving endothelial function; subgroup analyses also suggested a benefit on glucose metabolism, myocardial mass and improved diastolic function in subjects with MetS and early organ damage.
Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity in patients with MetS and increased LV mass.
168 patients will be enrolled in this randomized, double-blind, parallel-group, placebo-controlled trial; active treatment will consist of Armolipid Plus (1 tbl qd).
Primary end point will be the reduction of the insulin resistance in patients with metabolic syndrome and increased LV mass.
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: 1 tablet daily in the evening after dinner for 24 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 tablet matching Armolipid Plus daily in the evening after dinner for 24 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- male and Female 18-70 aged, with diagnosis of metabolic syndrome, defined by the presence of waist circumference >102 cm (♂) or >88 cm(♀), and two or more of these criteria:
- left ventricular hypertrophy: left ventricular mass indexed to height >44 g/m2,7(♀)or >48 g/m2(♂).
- antihypertensive and lipid-lowering therapy (if applicaple) stable for at least three months.
- ability to understand and sign an informed consent form.
Key exclusion criteria (18 listed)
- pregnancy or lactation period
- diabetes mellitus or pharmacological treatment for this condition
- hepatic failure
- creatininemia >2mg/dl
- triglyceridemia >500mg/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 Plus | Dietary supplement | Armolipid Plus |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Primary outcome measure will be the reduction of the insulin/glucose ratio, both after overnight fast (HOMA index)
Time frame: 6 months
1 secondary outcome
cardiac remodeling assessed by echocardiogram, lipid profile, subtypes of LDL, blood pressure, and high-sensitivity C-reactive protein.
Time frame: 6 months
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 27 Oct 2015.
- Derived from this study: PubMed 31371114Mercurio V, Pucci G, Bosso G, Fazio V, Battista F, Iannuzzi A, Brambilla N, Vitalini C, D'Amato M, Giacovelli G, Vaudo G, Schillaci G, Galletti F, Bonaduce D. A nutraceutical combination reduces left ventricular mass in subjects with metabolic syndrome and left ventricular hypertrophy: A multicenter, randomized, double-blind, placebo-controlled trial. Clin Nutr. 2020 May;39(5):1379-1384. doi: 10.1016/j.clnu.2019.06.026. Epub 2019 Jul 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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 and Insulin-resistance, run by Rottapharm at 3 sites 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 8 inclusion and 18 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 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Primary outcome measure will be the reduction of the insulin/glucose ratio, both after overnight fast (HOMA index) (time frame: 6 months). 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 NCT02295176, which also lists 1 linked publication.
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 27 Oct 2015.