Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-000731-31
    Sponsor's Protocol Code Number:NL76746.068.21
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-10-08
    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 number2021-000731-31
    A.3Full title of the trial
    Targeting the beta-2 adrenergic pathway to improve skeletal muscle
    glucose uptake in obese humans
    Activatie van het beta-2 adrenerge pathway in obese mensen om de
    glucose opname door de spier te verbeteren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of a new way for sugar uptake by the skeletal muscle in obese humans
    Onderzoek naar een nieuwe manier van suiker opname door de spier in obese mensen
    A.3.2Name or abbreviated title of the trial where available
    Clenbuterol study
    Clenbuterol studie
    A.4.1Sponsor's protocol code numberNL76746.068.21
    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 supportEurostars
    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 pointClinicaltrials.gov
    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-mailsten.vanbeek@maastrichtuniversity.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    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 No
    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 nameClenbuterol hydrochloride
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLENBUTEROL
    D.3.9.1CAS number 37148-27-9
    D.3.9.4EV Substance CodeSUB06651MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    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
    Type 2 diabetes mellitus
    Type 2 diabetes mellitus
    E.1.1.1Medical condition in easily understood language
    Diabetes
    Suikerziekte
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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
    To determine if prolonged treatment (4 weeks) with the selective beta-2 adrenergic agonist clenbuterol improves in vivo glucose disposal in quadriceps muscle via the mTORC2 pathway in obese male and (postmenopausal) women
    Om te onderzoeken of supplementatie met de selective beta-2 agonist clenbuterol voor een langere tijd (4 weken) de glucose opname in quadriceps spier kan verbeteren via de mTORC2 pathway in obese mannen en (post-menopausale) vrouwen.
    E.2.2Secondary objectives of the trial
    To determine if prolonged treatment (4 weeks) with the selective beta- 2 adrenergic agonist clenbuterol enhances BAT mass and activity in obese male and (postmenopausal) women.
    Om te onderzoeken of supplementatie met de selective beta-2 agonist clenbuterol voor langere tijd (4 weken) de activatie en massa van bruin vet kan verbeteren in obese mannen en (post-menopausale) vrouwen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or (postmenopausal; defined as 1 year after the last cycle) female;
    2. Age between 40-70 years;
    3. BMI: 27-35 kg/m2;
    1. Man of (postmenopausaal; gedefinieerd als minimaal 1 jaar na de laatste cyclus) vrouw
    2. Leeftijd tussen de 40-70 jaar
    3. BMI: 27-35 kg/m2
    E.4Principal exclusion criteria
    1. Not meeting all inclusion criteria
    2. Cardiovascular disease (determined by means of questionnaires, heart rate/blood pressure measurements and an ECG)
    3. Respiratory diseases (including asthma, bronchitis and COPD);
    4. Unstable body weight (weight gain or loss > 5 kg in the last three months);
    5. Intention to lose or gain body weight (e.g. with caloric restriction or physical activity)
    6. Excessive alcohol and/or drug abuse;
    7. Hypokalaemia;
    8. Hyperthyroidism
    9. Anaemia;
    10. Epilepsy;
    11. Smoking;
    12. Renal and/or liver insufficiency;
    13. Diagnosed with type 1 or type 2 diabetes mellitus;
    14. Any contra-indications to MRI scanning. These contra-indications include patients with:
    a. Electronic implants such as pacemakers, defibrillators or neurostimulators
    b. Central nervous system aneurysm clip
    c. Some hearing aids (such as cochlear implant) and artificial (heart) valves which are contraindicated for MRI/MRS
    d. Iron containing corpora aliena in the eye or brains
    e. Claustrophobia
    15. Participation in another biomedical study within 1 month before the first study visit, possibly interfering with the study results;
    16. Medication use known to hamper subject’s safety during the study procedures; 

    17. Subjects who do not want to be informed about unexpected medical findings; 

    18. Subjects who do not want that their treating physician to be informed;
    19. Inability to participate and/or complete the required measurements;
    20. Participation in organised or structured physical exercise;
    21. Any condition, disease or abnormal laboratory test result that, in the opinion of the Investigator, would interfere with the study outcome, affect trial participation or put the subject at undue risk;
    1. Niet voldoen aan alle inclusie criteria
    2. Cardiovasculaire ziekten (bepaald a.d.h.v. vragenlijsten, hartslag/bloeddruk en ECG)
    3. Luchtwegaandoeningen (inclusief asthma, bronchitis en COPD)
    4. Geen stabiel lichaamsgewicht (gewicht toe- of afname van >5 kg in de laatste 3 maanden)
    5. Intentie om lichaamsgewicht bij te komen of af te vallen (bijvoorbeeld door calorie restrictie of fysieke activiteit)
    6. Overmatig gebruik van alcohol of drugs gebruik
    7. Hypokaliëmie
    8. Hyperthyroïdie
    9. Anemie
    10. Epilepsie
    11. Roken
    12. Nier of lever insuffiëntie
    13. Gediagnosticeerd met type 1 of type 2 diabetes mellitus
    14. Contra-indicaties voor MRI scanners. Deze contra-indicaties zijn o.a. patiënten met:
    a. Electronische implantaten zoals pacemakers, defibrillators of neurostimulatoren
    b. Centrale zenuwstelsel aneurisma clips
    c. Bepaalde gehoortoestellen (zoals een cochlear implantaat) en kunstmatige (hart) kleppen die niet geschikt zijn voor MRI/MRS
    d. IJzer bevattende corpora aliena in de ogen of hersenen
    e. Claustrofobie
    15. Deelname aan een andere biomedische studie binnen 1 maand voor de eerste studie dag, die daarbij mogelijk de studie resultaten beïnvloeden.
    16. Medicatie waarvan bekend is dat het de veiligheid van de proefpersoon kan beïnvloeden tijdens de studie
    17. Proefpersonen die niet willen worden geïnformeerd over onverwachte medische bevindingen
    18. Proefpersonen die niet willen dat hun behandelende arts wordt geïnformeerd.
    19. Proefpersonen die niet in staat zijn deel te nemen/ de studie af te ronden.
    20. Proefpersonen die deelnemen aan gestructureerde fysieke activiteit.
    21. Een conditie, ziekte of abnormale laboratorium testuitslag die, in de ogen van de onderzoeker, de resultaten van de studie zouden kunnen beïnvloeden of de proefpersoon zouden blootstellen aan onnodige risico's.
    E.5 End points
    E.5.1Primary end point(s)
    insulin-stimulated 18F-FDG uptake in quadriceps muscle (Ki) as assessed by in PET-MRI.
    insuline-gestimuleerde 18F-FDG opname in quadriceps spieren (Ki) gemeten met gehulp van PET-MRI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Supplementation of clenbuterol/placebo will be 4 weeks. An interim analysis will be performed after the 10th subject. All data will be analysed after finalising the second intervention period of the 14th subject.
    De supplementatie van clenbuterol/placebo zal 4 weken worden gedaan. Een interim analyse zal plaatsvinden na de 10e proefpersoon. Alle data zal worden geanalyseerd nadat de tweede interventie van de 16e proefpersoon is afgelopen
    E.5.2Secondary end point(s)
    Insulin-stimulated 18F-FDG uptake in BAT (expressed as Ki) as assessed by means of PET-MRI
    Insuline gestimuleerde 18F-FDG opname in bruin vetweefsel (uitgedrukt als Ki) zoals gemeten met behulp van PET-MRI
    E.5.2.1Timepoint(s) of evaluation of this end point
    Supplementation of clenbuterol/placebo will be 4 weeks. An interim analysis will be performed after the 10th subject. All data will be analysed after finalising the second intervention period of the 16th subject.
    De supplementatie van clenbuterol/placebo zal 4 weken worden gedaan. Een interim analyse zal plaatsvinden na de 10e proefpersoon. Alle data zal worden geanalyseerd nadat de tweede interventie van de 16e proefpersoon is afgelopen
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    IMP is used to investigate whether selective beta-2 adrenergic agonist
    stimulation enhances skeletal muscle glucose uptake through the
    mTORC2-GLUT4 pathway
    De IMP zal worden gebruikt om te onderzoeken of selectieve beta-2 agonist stimulatie de glucose opname in de spier kan verbeteren via de mTORC2-GLUT4 pathway
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    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 years2
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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
    N.A.
    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 Decision2021-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-03-01
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 04 00:46:59 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA