Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
Study NCT ID:
NCT06304506
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Obesity on Extracellular Matrix Composition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003430', 'term': 'Cross-Sectional Studies'}], 'ancestors': [{'id': 'D016021', 'term': 'Epidemiologic Studies'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cross sectional study with three groups'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2024-02-14', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of obesity and age on adipose tissue extracellular matrix composition', 'timeFrame': 'The human experimental days will be done over the first 6 months of 2024. After informed consent is obtained, each participant will be tested on one day. The laboratory tissue analysis will be performed second half of 2024.', 'description': 'Adipose tissue extracellular matrix composition will be measured in abdominal subcutaneous adipose tissue sampled 3-5 cm lateral to the umbilicus in 30 male subjects; hereof 10 young, 10 old and 10 young and obese.\n\nIn brief the tissue will be delipidated and subsequently separated by DEAE chromotography (A weak anion exchange) and subsequently analysis of glycosaminoglycan disaccharide composition will be performed by MS.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Extracellular matrix compostion', 'Obesity', 'Age'], 'conditions': ['Adipose Tissue']}, 'descriptionModule': {'briefSummary': 'The experiment is a simple cross-sectional study with three groups (n=10) in each group, young and old healthy men and obese young men. The study will investigate the composition of the adipose tissue extra cellular matrix.\n\nThe main questions to answer,\n\n\\- is there differences in the adipose tissue extracellular matrix in obese compared to young men is there differences in the adipose tissue extracellular matrix in old compared to young men', 'detailedDescription': 'Three groups of young (n=10) and old (n=10) healthy men and obese young (n=10) men are recruited.\n\nAfter verbal and written information is provided signed consent is obtained.\n\nSubjects arrive at the lab overnight fasted and not having done exercise the prior day and having consumed a normal isocaloric carbohydrate rich diet.\n\nAfter a voiding and a 15 min rest body composition is determined by DXA. After this blood pressure is measured in the supine position in triplicate separated by 1 min. Following this a venous blood sample is obtained from a cubital vein, and kept on ice until further handling.\n\nSubsequently an adipose tissue biopsy is obtained by the Bergström technique applied with suction from an incision 3-5 cm lateral from the umbilicus. After compression and a 30 min rest, the subject perform an incremental exercise test to determine maximal fat oxidation. In brief pulmonary oxygen uptake and carbon dioxide excretion is measured using a COSMED Quark B2 on-line system during 5 min rest sitting on a cycle ergometer, and then during exercise with 3 min increments starting at 60 Watt and increasing by 35 watts. When the respiratory exchange ratio is above 1 the exercise is stopped. After a 5 min break an incremental test until voluntary exhaustion is performed to determine maximal oxygen uptake. This completes the experiment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men aged \\[18,35\\] and BMI \\[20,25\\]\n* Obese men aged \\[18,35\\] and BMI \\[30,40\\]\n* Healthy older men aged \\[60,75\\] and BMI \\[20,25\\]\n\nExclusion Criteria:\n\n* Present or former cardiovascular disease and chronical inflammatory disease\n* Consumption of medications and supplements that influence substrate use at rest and/or during exercise'}, 'identificationModule': {'nctId': 'NCT06304506', 'acronym': 'EOBECM', 'briefTitle': 'Effect of Obesity on Extracellular Matrix Composition', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Effect of Obesity on Extracellular Matrix Composition in Healthy Males With Normal and High BMI', 'orgStudyIdInfo': {'id': '514-0894/23-3000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Young obese men', 'description': 'BMI \\[30, 40\\] Age \\[18, 35\\]', 'interventionNames': ['Other: Cross sectional study']}, {'type': 'EXPERIMENTAL', 'label': 'Young healthy men', 'description': 'BMI \\[20, 25\\] Age \\[18, 35\\]', 'interventionNames': ['Other: Cross sectional study']}, {'type': 'EXPERIMENTAL', 'label': 'Old healthy men', 'description': 'BMI \\[20, 25\\] Age \\[60, 75\\]', 'interventionNames': ['Other: Cross sectional study']}], 'interventions': [{'name': 'Cross sectional study', 'type': 'OTHER', 'description': 'Physiological testing, Sampling of blood and abdominal adipose tissue and respiratory measurements at rest and during exercise', 'armGroupLabels': ['Old healthy men', 'Young healthy men', 'Young obese men']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jørn M Helge, PhD', 'role': 'CONTACT', 'email': 'jhelge@sund.ku.dk', 'phone': '+4528757506'}], 'facility': 'Xlab, Faculty of Health and Medical Sciences, University of Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Jørn Wulff W Helge, PhD', 'role': 'CONTACT', 'email': 'jhelge@sund.ku.dk', 'phone': '+4528757506'}, {'name': 'Christoffer Clemmensen, PhD', 'role': 'CONTACT', 'email': 'chc@sund.ku.dk', 'phone': '+4522916363'}], 'overallOfficials': [{'name': 'Jørn W Helge, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'The data will be available after publication and indefinately', 'ipdSharing': 'YES', 'description': 'When the experiments are concluded and the paper(s) are accepted that data will be able upon reasonable request', 'accessCriteria': 'Not known at this state'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jørn Wulff Helge', 'investigatorAffiliation': 'University of Copenhagen'}}}}