Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-02-22 @ 9:36 AM
Study NCT ID:
NCT02524457
Status:
UNKNOWN
Last Update Posted:
2015-08-14
First Post:
2015-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
How Menopause Affects Lipid Metabolism in the Visceral Fat Depots
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood and fat biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-13', 'studyFirstSubmitDate': '2015-08-11', 'studyFirstSubmitQcDate': '2015-08-13', 'lastUpdatePostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin sensitivity', 'timeFrame': '4 weeks', 'description': 'measured through a hyperinsulinemic euglycemic clamp (Outcome: glucose infusion rate)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Insulin Sensitivity and Lipid Metabolism']}, 'referencesModule': {'references': [{'pmid': '23548615', 'type': 'BACKGROUND', 'citation': 'Abildgaard J, Pedersen AT, Green CJ, Harder-Lauridsen NM, Solomon TP, Thomsen C, Juul A, Pedersen M, Pedersen JT, Mortensen OH, Pilegaard H, Pedersen BK, Lindegaard B. Menopause is associated with decreased whole body fat oxidation during exercise. Am J Physiol Endocrinol Metab. 2013 Jun 1;304(11):E1227-36. doi: 10.1152/ajpendo.00492.2012. Epub 2013 Apr 2.'}, {'pmid': '25000528', 'type': 'BACKGROUND', 'citation': 'Abildgaard J, Henstridge DC, Pedersen AT, Langley KG, Scheele C, Pedersen BK, Lindegaard B. In vitro palmitate treatment of myotubes from postmenopausal women leads to ceramide accumulation, inflammation and affected insulin signaling. PLoS One. 2014 Jul 7;9(7):e101555. doi: 10.1371/journal.pone.0101555. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to describe the molecular mechanisms related to an increased visceral fat mass and changed T-cell homeostasis. the project is expected to add new knowledge to the field of metabolic diseases after menopause and increase the focus of how lipid affects the development of metabolic disease in relation to the menopausal transition.', 'detailedDescription': 'The study is a cross sectional study including 60 women between 45 and 55 years of age. Investigators aim to include 20 premenopausal women, 20 postmenopausal women and 20 postmenopausal women taking hormone treatment (HT). All the women are going through gynecological surgery for benign reasons. During the operation investigators will take a visceral fat biopsy from the omentum.\n\nmaximally 1 month before- or after the operation the subject will meet at the lab for further testing, including:\n\n* Health examination\n* Blood samples\n* OGTT\n* DXA scan\n* VO2 max testing\n* MRI of the abdomen\n* hyperinsulinemic euglycemic clamp'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women from 45-55 years of age undergoing gynecological surgery for benign reasons.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women\n* 45-55 years old\n* for HT treated women (HT more than 1 year)\n\nExclusion Criteria:\n\n* Infections during the last month\n* chronic disease\n* claustrophobia\n* smoking\n* Alcoholic intake \\> 14 servings\n* hysterectomy before menopause\n* oophorectomized\n* early menopause (before 40 yrs)\n* BMI \\> 30'}, 'identificationModule': {'nctId': 'NCT02524457', 'briefTitle': 'How Menopause Affects Lipid Metabolism in the Visceral Fat Depots', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'How Menopause Affects Lipid Metabolism in the Visceral Fat Depots', 'orgStudyIdInfo': {'id': 'H-3-2014-096'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Premenopausal', 'description': 'Premenopausal women going through gynecological surgery', 'interventionNames': ['Other: This is an observational study. There are no interventions']}, {'label': 'Postmenopausal', 'description': 'Postemnopausal women going through gynecological surgery', 'interventionNames': ['Other: This is an observational study. There are no interventions']}, {'label': 'Postmenopausal + HT', 'description': 'Postmenopausal women going through gynecological surgery who has been taking hormone treatment through the past year (as a minimum)', 'interventionNames': ['Other: This is an observational study. There are no interventions']}], 'interventions': [{'name': 'This is an observational study. There are no interventions', 'type': 'OTHER', 'armGroupLabels': ['Postmenopausal', 'Postmenopausal + HT', 'Premenopausal']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Julie Abildgaard, MD', 'role': 'CONTACT', 'email': 'julie.abildgaard.01@regionh.dk', 'phone': '+4535457190'}], 'overallOfficials': [{'name': 'Julie Abildgaard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, phd-student', 'investigatorFullName': 'Anders Rasmussen Rinnov', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}