Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 11:19 PM
Study NCT ID:
NCT02076932
Status:
COMPLETED
Last Update Posted:
2016-06-01
First Post:
2014-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Physical Training on Adipose Tissue Metabolism and Insulin Sensitivity in the Menopausal Transition Phase
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'C564221', 'term': 'Glucocorticoid Receptor Deficiency'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-31', 'studyFirstSubmitDate': '2014-02-24', 'studyFirstSubmitQcDate': '2014-03-03', 'lastUpdatePostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Dietary registration', 'timeFrame': 'Baseline and 3 months', 'description': 'Daily food intake for three week days and one week-end day will be reported by the subjects'}], 'primaryOutcomes': [{'measure': 'Insulin stimulated uptake of glucose in adipose tissue', 'timeFrame': 'Baseline and 3 months', 'description': 'Measured by Positron Emission Tomography-Computed tomography (PET/CT)'}, {'measure': 'Hyperinsulinemic euglycemic clamp', 'timeFrame': 'Baseline and 3 months', 'description': 'Glucose metabolized (mg/kg/min)'}, {'measure': 'Adipose tissue distribution', 'timeFrame': 'Baseline and 3 months', 'description': 'Accessed by Magnetic Resonance Imaging (MRI).'}], 'secondaryOutcomes': [{'measure': 'Central insulin sensitivity', 'timeFrame': 'Baseline and 3 months', 'description': 'Fasting plasma insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test'}, {'measure': 'Maximal oxygen uptake (ml/O2/kg/min)', 'timeFrame': 'Baseline and 3 months', 'description': 'Measured using indirect calorimetry and an incremental bicycle protocol'}, {'measure': 'Metabolic syndrome', 'timeFrame': 'Baseline and 3 months', 'description': 'As measured by high density lipoprotein, triglycerides, waist circumference, blood pressure, mean arterial pressure, fasting glucose and composite metabolic syndrome scores'}, {'measure': 'Health related quality of life', 'timeFrame': 'Baseline and 3 months', 'description': 'Measured using questionaries, semi-structured interviews and observations'}, {'measure': 'Anthropometry', 'timeFrame': 'Baseline and 3 months', 'description': 'Measured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height'}, {'measure': 'Skeletal muscle biopsy', 'timeFrame': 'Baseline and 3 months', 'description': 'Biochemical, proteomics, metabolomics, genomics and morphological analyses'}, {'measure': 'Abdominal subcutaneous adipose tissue biopsy', 'timeFrame': 'Baseline and 3 months', 'description': 'Biochemical, proteomics, metabolomics, genomics and morphological analyses'}, {'measure': 'Resting metabolic rate', 'timeFrame': 'Baseline and 3 months', 'description': 'Will be measured by indirect calorimetry'}, {'measure': 'Physical activity level and duration of sleep', 'timeFrame': 'Baseline and 3 months', 'description': 'Daily activity and duration of sleep will be recorded during one week using Actibelt® and self reporting'}, {'measure': 'Microdialysis', 'timeFrame': 'Baseline and 3 months', 'description': 'Adipose tissue microdialysis'}, {'measure': 'Femoral subcutaneous adipose tissue biopsy', 'timeFrame': 'Baseline and 3 months', 'description': 'Biochemical, proteomics, metabolomics, genomics and morphological analyses'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Menopause', 'Insulin Resistance', 'Body Composition, Beneficial']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if physical exercise reduces the adverse changes in adipose tissue metabolism and insulin sensitivity that occurs in women during the menopausal transition.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '57 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premenopausal OR Postmenopausal (45-57 years)\n* No chronical Diseases\n* BMI \\> 18,5 and \\< 30\n* Sedentary (no regular physical activity the last 2 years)\n* Either regular bleeding (premenopausal) OR no menstruation for at least 2 years (postmenopausal)\n* Plasma measurements:\n\nPremenopausal: estradiol \\> 0.20nmol/l, Follicle Stimulating Hormone \\< 22 IU/l and progesterone \\> 2.5 nmol/l Postmenopausal: estradiol \\< 0.20nmol/l, Follicle Stimulating Hormone \\> 22 IU/l and progesterone from 0.3-2.5 nmol/l\n\nExclusion Criteria:\n\n* Smoking\n* Excessive alcohol intake\n* Regular medication including hormone replacement treatment'}, 'identificationModule': {'nctId': 'NCT02076932', 'briefTitle': 'Effects of Physical Training on Adipose Tissue Metabolism and Insulin Sensitivity in the Menopausal Transition Phase', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'A Training Intervention Study in Late Pre- and Early Postmenopausal Women Investigating the Changes in Adipose Tissue Metabolism and Peripheral Insulin Sensitivity', 'orgStudyIdInfo': {'id': 'CWS menopause, adipose tissue'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Premenopausal women', 'description': 'The premenopausal women will be attending Spinning classes.', 'interventionNames': ['Behavioral: Spinning']}, {'type': 'EXPERIMENTAL', 'label': 'Postmenopausal Women', 'description': 'The postmenopausal women will be attending Spinning classes.', 'interventionNames': ['Behavioral: Spinning']}], 'interventions': [{'name': 'Spinning', 'type': 'BEHAVIORAL', 'description': 'After the baseline studies, the women will perform Spinning three times a week. Two of the sessions are performed on our location by trained instructors and the third training is self-training in a local fitness center where we provide free membership. All trainings are heart rate monitored.', 'armGroupLabels': ['Postmenopausal Women', 'Premenopausal women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen N', 'country': 'Denmark', 'facility': 'Department og Biomedical Sciences'}], 'overallOfficials': [{'name': 'Ylva Hellsten, Proff.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}, {'name': 'Bente M Stallknecht, Proff. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD', 'investigatorFullName': 'Bente Merete Stallknecht', 'investigatorAffiliation': 'University of Copenhagen'}}}}