Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-09 @ 3:53 AM
Study NCT ID:
NCT01680133
Status:
COMPLETED
Last Update Posted:
2012-10-12
First Post:
2012-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regulation of Tissue Lipolysis by Insulin in Type 2 Diabetes
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'adipose tissue and skeletal muscle biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-11', 'studyFirstSubmitDate': '2012-08-21', 'studyFirstSubmitQcDate': '2012-09-06', 'lastUpdatePostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in insulin sensitivity of adipose tissue and skeletal muscle lipolysis', 'timeFrame': '8, 20 and 40 mU insulin (2 hours)', 'description': 'Changes from baseline in glycerol (lactate, pyruvate and glucose) in tissue microdialysate during a 3 step euglycemic hyperinsulinemic clamp (8, 20 and 40mU of insulin), every step for 2h'}], 'secondaryOutcomes': [{'measure': 'Baseline adipose tissue and skeletal muscle gene expression', 'timeFrame': 'baseline', 'description': 'gene expression of genes related to lipid, glucose metabolism, insulin signalling will be measured in baseline adipose tissue and skeletal muscle biopsies'}, {'measure': 'Baseline skeletal muscle lipid accumulation', 'timeFrame': 'Baseline', 'description': 'Baseline skeletal muscle lipid accumulation is measured (TAG, DAG, Phospholipid and fatty acids)'}]}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '20843949', 'type': 'BACKGROUND', 'citation': 'Jocken JW, Moro C, Goossens GH, Hansen D, Mairal A, Hesselink MK, Langin D, van Loon LJ, Blaak EE. Skeletal muscle lipase content and activity in obesity and type 2 diabetes. J Clin Endocrinol Metab. 2010 Dec;95(12):5449-53. doi: 10.1210/jc.2010-0776. Epub 2010 Sep 15.'}, {'pmid': '18398140', 'type': 'BACKGROUND', 'citation': 'Jocken JW, Roepstorff C, Goossens GH, van der Baan P, van Baak M, Saris WH, Kiens B, Blaak EE. Hormone-sensitive lipase serine phosphorylation and glycerol exchange across skeletal muscle in lean and obese subjects: effect of beta-adrenergic stimulation. Diabetes. 2008 Jul;57(7):1834-41. doi: 10.2337/db07-0857. Epub 2008 Apr 8.'}, {'pmid': '18060661', 'type': 'BACKGROUND', 'citation': 'Jocken JW, Goossens GH, van Hees AM, Frayn KN, van Baak M, Stegen J, Pakbiers MT, Saris WH, Blaak EE. Effect of beta-adrenergic stimulation on whole-body and abdominal subcutaneous adipose tissue lipolysis in lean and obese men. Diabetologia. 2008 Feb;51(2):320-7. doi: 10.1007/s00125-007-0866-y. Epub 2007 Dec 5.'}, {'pmid': '17131144', 'type': 'BACKGROUND', 'citation': 'Boon H, Blaak EE, Saris WH, Keizer HA, Wagenmakers AJ, van Loon LJ. Substrate source utilisation in long-term diagnosed type 2 diabetes patients at rest, and during exercise and subsequent recovery. Diabetologia. 2007 Jan;50(1):103-12. doi: 10.1007/s00125-006-0482-2. Epub 2006 Nov 28.'}, {'pmid': '23907381', 'type': 'DERIVED', 'citation': 'Jocken JW, Goossens GH, Boon H, Mason RR, Essers Y, Havekes B, Watt MJ, van Loon LJ, Blaak EE. Insulin-mediated suppression of lipolysis in adipose tissue and skeletal muscle of obese type 2 diabetic men and men with normal glucose tolerance. Diabetologia. 2013 Oct;56(10):2255-65. doi: 10.1007/s00125-013-2995-9. Epub 2013 Aug 2.'}]}, 'descriptionModule': {'briefSummary': 'Inadequate suppression of intramuscular and adipose tissue lipolysis, and consequent excessive delivery of fatty acids to ectopic tissues (e.g. muscle, pancreas and liver) could play an important role in the development and exacerbating of insulin resistance. Therefore, the investigators propose to study the regulation of adipose tissue and skeletal muscle lipolysis, as well as further characterize the intracellular lipolytic pathways within these tissues, in obese normoglycaemic versus long-term diagnosed type 2 diabetic subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy normoglycemic men and type 2 diabetic men', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasian\n* Normal blood pressure (SBP 100-140 mmHg, DBP 60-90 mmHg)\n* weight stable in last 3 months\n\nExclusion Criteria:\n\n* Smokers\n* people with intensive fitness training (e.g. athletes \\> 3 times/week)\n* History of cardiovascular diseases\n* Bleeding disorders\n* Use of medication interfering with the study endpoints/hypotheses (e.g. beta-blockers)\n* Not to be able to understand the study information\n* Subjects on a special diet or vegetarian\n* Blood donation 2 months prior to the study and during the study\n* Participating in an other study'}, 'identificationModule': {'nctId': 'NCT01680133', 'briefTitle': 'Regulation of Tissue Lipolysis by Insulin in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Regulation of Lipolysis by Insulin in Skeletal Muscle and Adipose Tissue in Type 2 Diabetes', 'orgStudyIdInfo': {'id': '07-3-037'}, 'secondaryIdInfos': [{'id': '91611074', 'type': 'OTHER_GRANT', 'domain': 'The Netherlands Organisation for Scientific Research'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'NGT', 'description': 'Normal glycaemic healthy control men, age between 45-65, BMI 25-35 kg/m2', 'interventionNames': ['Other: Hyperinsulinemic euglycemic clamp']}, {'label': 'T2D', 'description': 'Type 2 diabetic men, age 45-65 yrs, BMI 25-35, diagnosed \\>5yrs and Hba1c 7-9%', 'interventionNames': ['Other: Hyperinsulinemic euglycemic clamp']}], 'interventions': [{'name': 'Hyperinsulinemic euglycemic clamp', 'type': 'OTHER', 'armGroupLabels': ['NGT', 'T2D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6200MD', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Department of Human Biology, Maastricht University Medical Centre', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Ellen Blaak, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Netherlands Organisation for Scientific Research', 'class': 'OTHER_GOV'}, {'name': 'European Foundation for the Study of Diabetes', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}