Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2026-01-22 @ 7:07 AM
Study NCT ID:
NCT04921306
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2021-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obese Human Beta-2-adrenergic Stimulation and Muscle Glucose Uptake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2021-05-25', 'studyFirstSubmitQcDate': '2021-06-02', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Body weight', 'timeFrame': '4 weeks', 'description': 'Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on body weight'}, {'measure': 'Lean mass', 'timeFrame': '4 weeks', 'description': 'Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on lean mass as assessed by Bodpod measurement'}, {'measure': 'Fat mass', 'timeFrame': '4 weeks', 'description': 'Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on fat mass as assessed by Bodpod measurement'}, {'measure': 'Glucose infusion rate (GIR)', 'timeFrame': '4 weeks', 'description': 'Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on glucose-infusion rate (GIR) during a one-step hyperinsulinemic-euglycemic clamp'}, {'measure': 'Plasma insulin concentrations', 'timeFrame': '4 weeks', 'description': 'Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on plasma insulin concentrations'}, {'measure': 'Plasma glucose concentrations', 'timeFrame': '4 weeks', 'description': 'Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on plasma glucose concentrations'}, {'measure': 'Plasma free fatty acid (FFA) concentrations', 'timeFrame': '4 weeks', 'description': 'Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on plasma FFA concentrations'}, {'measure': 'Plasma triacylglycerol (TAG) concentrations', 'timeFrame': '4 weeks', 'description': 'Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on plasma (TAG) concentrations'}, {'measure': 'Heart rate', 'timeFrame': '4 weeks', 'description': 'Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on heart rate as assessed by means of an automated cuff'}, {'measure': 'Blood pressure', 'timeFrame': '4 weeks', 'description': 'Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on blood pressure (systolic and diastolic blood pressure) as assessed by means of an automated cuff'}, {'measure': 'Energy expenditure', 'timeFrame': '4 weeks', 'description': 'Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on energy expenditure as measured by indirect calorimetry'}, {'measure': 'Substrate oxidation', 'timeFrame': '4 weeks', 'description': 'Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on substrate oxidation as measured by indirect calorimetry'}, {'measure': 'Sleeping energy expenditure', 'timeFrame': '4 weeks', 'description': 'Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on sleeping energy expenditure as assessed by means of whole-room indirect calorimetry'}, {'measure': 'Substrate oxidation during sleep', 'timeFrame': '4 weeks', 'description': 'Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on substrate oxidation during sleep as assessed by means of whole-room indirect calorimetry'}, {'measure': 'Skeletal muscle gene expression', 'timeFrame': '4 weeks', 'description': 'Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle gene expression of insulin signalling and beta-adrenergic pathways as determined in muscle biopsies by means of RT-qPCR'}, {'measure': 'Skeletal muscle protein expression', 'timeFrame': '4 weeks', 'description': 'Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle protein expression of insulin signalling and adrenergic signalling pathways as determined in muscle biopsies by means of Western blot'}, {'measure': 'Femoral artery flow mediated dilation', 'timeFrame': '4 weeks', 'description': 'Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on FMD as assessed by means of echo-doppler'}, {'measure': 'skeletal muscle GLUT4 translocation', 'timeFrame': '4 weeks', 'description': 'Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle GLUT4 translocation as assessed by means of wide-field microscopy in skeletal muscle biopsies'}], 'primaryOutcomes': [{'measure': 'insulin-stimulated fluorodeoxyglucose (18F-FDG) uptake in quadriceps muscle.', 'timeFrame': '4 weeks', 'description': 'Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on insulin-stimulated 18F-FDG uptake in quadriceps muscle as assessed using radio-active labelled tracer (18F-FDG) in positron emission tomogaphy magnetic resonance imaging (PET-MRI).'}], 'secondaryOutcomes': [{'measure': 'insulin-stimulated 18F-FDG uptake in BAT', 'timeFrame': '4 weeks', 'description': 'Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on insulin-stimulated 18F-FDG uptake in BAT as assessed using radio-active labelled tracer (18F-FDG) in PET-MRI.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of four weeks clenbuterol/placebo supplementation on skeletal muscle glucose disposal in overweight/obese male and (postmenopausal) female volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Caucasian;\n2. Male or (postmenopausal; defined as 1 year after the last cycle) female;\n3. Age between 40-70 years;\n4. BMI: 27-35 kg/m2;\n\nExclusion Criteria:\n\n1. Not meeting all inclusion criteria\n2. Cardiovascular disease (determined by means of questionnaires, heart rate/blood pressure measurements and an ECG)\n3. Respiratory diseases (including asthma, bronchitis and COPD);\n4. Unstable body weight (weight gain or loss \\> 3 kg in the last three months);\n5. Intention to lose or gain body weight (e.g. with caloric restriction or physical activity)\n6. Excessive alcohol and/or drug abuse;\n7. Hypokalaemia;\n8. Hyperthyroidism\n9. Anaemia;\n10. Epilepsy;\n11. Smoking;\n12. Renal and/or liver insufficiency;\n13. Diagnosed with type 1 or type 2 diabetes mellitus;\n14. Any contra-indications to MRI scanning. These contra-indications include patients with:\n\n 1. Electronic implants such as pacemakers, defibrillators or neurostimulators\n 2. Central nervous system aneurysm clip\n 3. Some hearing aids (such as cochlear implant) and artificial (heart) valves which are contraindicated for MRI/MRS\n 4. Iron containing corpora aliena in the eye or brains\n 5. Claustrophobia\n15. Participation in another biomedical study within 1 month before the first study visit, possibly interfering with the study results;\n16. Medication use known to hamper subject's safety during the study procedures;\n17. Subjects who do not want to be informed about unexpected medical findings;\n18. Subjects who do not want that their treating physician to be informed;\n19. Inability to participate and/or complete the required measurements;\n20. Participation in organised or structured physical exercise (\\>2h per week);\n21. 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;"}, 'identificationModule': {'nctId': 'NCT04921306', 'briefTitle': 'Obese Human Beta-2-adrenergic Stimulation and Muscle Glucose Uptake', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University'}, 'officialTitle': 'Targeting the Beta-2-adrenergic Pathway to Improve Skeletal Muscle Glucose Uptake in Obese Humans', 'orgStudyIdInfo': {'id': 'NL76746.068.21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clenbuterol hydrochloride', 'description': 'Subjects will ingest clenbuterol hydrochloride capsules (20 microgram/each) twice daily (40 microgram/day) for a maximum of 28 days.\n\nSubjects that received the clenbuterol hydrochloride capsules (at random) in the first study period will receive the placebo capsules during the second study period.', 'interventionNames': ['Drug: Clenbuterol Hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects will ingest placebo capsules matching the clenbuterol hydrochloride capsules one time per day for a maximum of 28 days.\n\nSubjects that received the placebo capsules (at random) in the first study period will receive the clenbuterol hydrochloride capsules during the second study period.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Clenbuterol Hydrochloride', 'type': 'DRUG', 'description': 'Daily ingestion of clenbuterol hydrochloride capsules (40 microgram/day) for a total period of 28 days with a wash-out period of at least 6-8 weeks.', 'armGroupLabels': ['Clenbuterol hydrochloride']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Daily ingestion of placebo capsules for a total period of 28 days with a wash-out period of at least 6-8 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eurostars', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}