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    Summary
    EudraCT Number:2014-001733-86
    Sponsor's Protocol Code Number:1710
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-10-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-001733-86
    A.3Full title of the trial
    The effect of L-arginine on brown adipose tissue metabolism in South Asian and white Caucasian subjects
    Het effect van L-arginine op bruin vet metabolisme in Hindoestaanse en Caucasische mannen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of the amino acid L-arginine on the function and activity of brown adipose tissue
    Het effect van het aminozuur L-arginine op de functie en activiteit van bruin vet
    A.3.2Name or abbreviated title of the trial where available
    L-arginine and brown adipose tissue
    L-arginine en bruin vet
    A.4.1Sponsor's protocol code number1710
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMaastricht University
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMaastricht University
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaastricht University
    B.5.2Functional name of contact pointStudy Information
    B.5.3 Address:
    B.5.3.1Street AddressUniversiteitssingel 50
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6229 ER
    B.5.3.4CountryNetherlands
    B.5.6E-mailm.boon@maastrichtuniversity.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Argimax (active substance: L-arginine)
    D.2.1.1.2Name of the Marketing Authorisation holderHankintatukku Oy
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameL-arginine (Argimax)
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Obesity, glucose intolerance, endothelial dysfunction
    Obesitas, glucose intolerantie, endotheeldysfunctie
    E.1.1.1Medical condition in easily understood language
    Obesity, dysfunction of Sugar metabolism, dysfunction of the blood vessels
    obesitas, niet goed functioneren van de suikerstofwisseling, niet goed functioneren van de bloedvaten
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In this study, we will investigate the influence of the amino acid L-arginine, which enhances release of nitric oxide in the body, on BAT activity and metabolism in healthy subjects with overweight. This will increase understanding on the effect of L-arginine and nitric oxide on overweight and BAT and hopefully, we will be more capable to treat overweight and obesity in the future.

    Primary study parameters:
    1) glucose uptake by brown adipose tissue
    2) energy expenditure
    3) fat mass

    Furthermore, for each of these primary study parameters we will investigate whether the effect differs between South Asians and Caucasians.

    In dit onderzoek wordt gekeken naar de invloed van het aminozuur L-arginine, dat leidt tot verhoogde afgifte van stikstofmono-oxide in het lichaam, op de activiteit van bruin vet en de stofwisseling bij gezonde proefpersonen met licht overgewicht. Zo kunnen we meer te weten komen over de invloed van L-arginine en stikstofmono-oxide op overgewicht en bruin vet en kunnen we overgewicht in de toekomst mogelijk beter behandelen.

    Primaire uitkomstmaten:
    1) Glucoseopname door bruin vet
    2) Energieverbruik
    3) Vetmassa

    Verder zal voor elk van deze primaire uitkomstmaten onderzocht worden of er een verschil is in het effect in Hindoestanen en Caucasiërs.
    E.2.2Secondary objectives of the trial
    1) Thermoregulation (skin temperature, core temperature, skin perfusion and endothelium-dependent and -independent vasodilation) and endothelial function
    2) Plasma lipids and glucose tolerance
    3) Systemic inflammation and adipose tissue inflammation
    4) Insulin signaling in muscle

    Furthermore, for each of these secondary study parameters we will investigate whether the effect differs between South Asians and Caucasians
    1) Thermoregulatie (huidtemperatuur, kerntemperatuur, huidperfusie en endotheel-afhankelijke en -onafhankelijke vasodilatatie) en endotheelfunctie
    2) Plasma lipiden en glucosetolerantie
    3) Systemische inflammatie en inflammatie van vetweefsel
    4) Insuline signaling in spier

    Verder zal voor elk van deze secundaire uitkomstmaten onderzocht worden of er een verschil is in het effect in Hindoestanen en Caucasiërs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Caucasian or South Asian ethnicity
    - Age: 35-50 years
    - Gender: male
    - BMI: 25-30 kg/m2
    - Plasma glucose levels 2 h after OGTT between 7.8 and 11 mM (e.g. impaired glucose tolerance)
    - Plasma L-arginine levels 41 – 114 uM (i.e. within healthy range)
    - Good general health
    - Caucasische of Hindoestaanse ethniciteit
    - Leeftijd: 35-50 jaar
    - Geslacht: man
    - BMI: 25-30 kg/m2
    - Plasma glucose levels 2 uur na OGTT tussen 7.8 en 11 mM (dus verminderde glucose tolerantie)
    - Plasma L-arginine levels 41 - 114 uM (dus binnen gezonde range)
    - goede algehele gezondheid
    E.4Principal exclusion criteria
    - Type 2 diabetes (determined on basis of oral glucose tolerance test)
    - BMI > 30 kg/m2
    - Plasma glucose levels 2 h after OGTT < 7.8 mM
    - Plasma L-arginine levels < 41 or > 114 uM
    - Use of beta-blockers < 1 month before start of study or during study
    - Participation in an intensive weight-loss program or vigorous exercise program during the last year before the start of the study
    - Abuse of drugs and/or alcohol
    - Hyperthyroidism or hypothyroidism
    - Systolic blood pressure < 90 mmHg
    - Haematocrit < 0.41 or > 0.51 l/l
    - Haemoglobin < 8.5 or > 11.0
    - Creatinine (enzymatic method) < 45 or > 100 μmol/L
    - ASAT > 45 U/L
    - ALAT > 50 U/L
    - Alkaline phosphatase > 125 U/L
    - Gamma GT > 45 U/L
    - Participation in earlier research or medical examinations that included PET-CT scanning
    - Psychologically unstable subjects (as judged by the treating medical specialist)
    - Subjects with mental retardation (as judged by the treating medical specialist)
    - Subjects with severe behavior disorders (as judged by the treating medical specialist)
    - type 2 diabetes (bepaald op basis van orale glucose tolerantie test)
    - BMI > 30 kg/m2
    - plasma glucose levels 2 uur na OGTT < 7.8 mM
    - Plasma L-arginine levels < 41 of > 114 uM
    - gebruik van beta-blockers < 1 maand voor start van de studie of tijdens de studie
    - deelname aan intensief programma voor gewichtsverlies of intensief trainingsprogramma tijdens het afgelopen jaar voor de studie
    - misbruik van drugs en/of alcohol
    - hyperthyreoïdie of hypothyreoidie
    - Systolische bloeddruk < 90 mmHg
    - Hematocriet < 0.41 or > 0.51 l/l
    - Hemoglobine < 8.5 or > 11.0
    - Creatinine < 45 or > 100 μmol/L
    - ASAT > 45 U/L
    - ALAT > 50 U/L
    - Alkalisch fosfatase > 125 U/L
    - Gamma GT > 45 U/L
    - deelname aan eerder onderzoek waarin een PET-CT scan werd gedaan
    - psychologisch onstabiele mensen (zoals beoordeeld door de behandelend arts)
    - mentaal geretardeerde mensen (zoals beoordeeld door de behandelend arts)
    - mensen met ernstige gedragsproblemen (zoals beoordeeld door de behandelend arts)
    E.5 End points
    E.5.1Primary end point(s)
    This study includes several parameters that are related to BAT activity, energy expenditure, thermoregulation, endothelial function and glucose tolerance/insulin sensitivity. Our main focus will be on BAT activity, which will be measured by means of static PET-CT scans. Our primary end points are:

    1) glucose uptake by brown adipose tissue
    2) energy expenditure
    3) fat mass

    Furthermore, for each of these primary study parameters we will investigate whether the effect differs between South Asians and Caucasians.
    In deze studie zullen verscheidene parameters worden onderzocht die geraleteerd zijn aan bruin vet activatie, energiegebruik, thermoregulatie, endotheelfunctie en glucosetolerantie/insuline gevoeligheid. Onze focus ligt met name op BAT activiteit, dat gemeten zal worden met statische PET-CT scans. Onze primaire uitkomstmaten zijn dan ook:
    1) glucoseopname door bruin vet
    2) energieverbruik
    3) vetmassa

    Verder kijken we voor elk van deze primaire uitkomstmaten of er verschillen zijn tussen Hindoestanen en Caucasiërs
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 weeks of treatment
    Na 6 weken behandeling
    E.5.2Secondary end point(s)
    1) Thermoregulation (skin temperature, core temperature, skin perfusion and endothelium-dependent and -independent vasodilation) and endothelial function
    2) Plasma lipids and glucose tolerance
    3) Systemic inflammation and adipose tissue inflammation
    4) Insulin signaling in muscle

    Furthermore, for each of these secondary study parameters we will investigate whether the effect differs between South Asians and Caucasians.
    1) Thermoregulatie (huidtemperatuur, kerntemperatuur, huidperfusie en endotheel-afhankelijke en -onafhankelijke vasodilatatie) en endotheelfunctie
    2) Plasma lipiden en glucosetolerantie
    3) Systemische inflammatie en inflammatie van vetweefsel
    4) Insuline signaling in spier

    Verder zal voor elk van deze secundaire uitkomstmaten onderzocht worden of er een verschil is in het effect in Hindoestanen en Caucasiërs
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 6 weeks of treatment
    Na 6 weken behandeling
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 26
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Subjects who are overweight and have impaired glucose tolerance
    Mensen die overgewicht hebben en een verminderde glucosetolerantie
    F.4 Planned number of subjects to be included
    F.4.1In the member state26
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Geen
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-09
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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