NCT02295176

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

October 27, 2015

Status Verified

October 1, 2015

Enrollment Period

1.9 years

First QC Date

November 5, 2014

Last Update Submit

October 26, 2015

Conditions

Metabolic SyndromeInsulin-resistanceLeft Ventricular Hypertrophy

Outcome Measures

Primary Outcomes (1)

  • Primary outcome measure will be the reduction of the insulin/glucose ratio, both after overnight fast (HOMA index)

    6 months

Secondary Outcomes (1)

  • cardiac remodeling assessed by echocardiogram, lipid profile, subtypes of LDL, blood pressure, and high-sensitivity C-reactive protein.

    6 months

Study Arms (2)

Armolipid Plus

EXPERIMENTAL

Armolipid Plus: 1 tablet daily in the evening after dinner for 24 weeks.

Dietary Supplement: Armolipid Plus

Placebo

PLACEBO COMPARATOR

1 tablet matching Armolipid Plus daily in the evening after dinner for 24 weeks

Dietary Supplement: Placebo

Interventions

Armolipid PlusDIETARY_SUPPLEMENT
Armolipid Plus
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • pregnancy or lactation period
  • diabetes mellitus or pharmacological treatment for this condition
  • hepatic failure
  • creatininemia \>2mg/dl
  • triglyceridemia \>500mg/dl
  • severe obesity (BMI \>35)
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Domenico Bonaduce

Naples, Naples, 80131, Italy

Location

Ferruccio Galletti

Naples, Italy

Location

Giuseppe Schillaci

Terni, Italy

Location

Related Publications (1)

  • 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.

    PMID: 31371114DERIVED

MeSH Terms

Conditions

Metabolic SyndromeInsulin ResistanceHypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2014

First Posted

November 20, 2014

Study Start

April 1, 2013

Primary Completion

March 1, 2015

Study Completion

July 1, 2015

Last Updated

October 27, 2015

Record last verified: 2015-10

Locations

IT(3)