Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-04-06 @ 6:28 AM
Study NCT ID:
NCT00612950
Status:
COMPLETED
Last Update Posted:
2008-02-12
First Post:
2008-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Beta-Cell Function After Near-Normalisation of Blood Glucose
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D054795', 'term': 'Incretins'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-11', 'studyFirstSubmitDate': '2008-01-16', 'studyFirstSubmitQcDate': '2008-02-11', 'lastUpdatePostDateStruct': {'date': '2008-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2.phase insulin response measured as incremental area under the curve from 10-120 minutes', 'timeFrame': '2 hours'}], 'secondaryOutcomes': [{'measure': '2.phase insulin response measured as incremental area under the curve from 10-120 minutes, after 4 weeks of insulin treatment', 'timeFrame': '2 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '19037628', 'type': 'DERIVED', 'citation': 'Hojberg PV, Vilsboll T, Rabol R, Knop FK, Bache M, Krarup T, Holst JJ, Madsbad S. Four weeks of near-normalisation of blood glucose improves the insulin response to glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide in patients with type 2 diabetes. Diabetologia. 2009 Feb;52(2):199-207. doi: 10.1007/s00125-008-1195-5. Epub 2008 Nov 27.'}]}, 'descriptionModule': {'briefSummary': 'The incretin effect is attenuated in patients with type 2 diabetes mellitus partly due to impaired potentiation of beta-cell responsiveness to glucose by glucose dependent insulinotropic polypeptide and glucagon-like peptide-1 respectively. The aim of the present study was to investigate whether 4 weeks of near-normalization of blood glucose could improve the insulin responses to GIP and GLP-1 in patients with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-70 years\n* Type 2 diabetes diagnosed after 30 years of age\n* BMI \\> 25\n\nExclusion Criteria:\n\n* Severe complications to diabetes\n* Abnormal liver and kidney function\n* Haemoglobin below the lower limit\n* Macroalbuminuria\n* Systemic disease\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00612950', 'briefTitle': 'Beta-Cell Function After Near-Normalisation of Blood Glucose', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Four Weeks of Near Normalisation of Blood Glucose Improves the Insulin Response to GLP-1 and GIP in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'KA 03005'}, 'secondaryIdInfos': [{'id': 'KA 03005'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLP-1', 'interventionNames': ['Drug: glucagon-like peptide-1,']}, {'type': 'EXPERIMENTAL', 'label': 'GIP', 'interventionNames': ['Drug: glucose dependent insulinotropic polypeptide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'saline', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'glucagon-like peptide-1,', 'type': 'DRUG', 'description': 'GLP-1:continuous infusion of ½ pmol/kg/min for a total time of 120 minutes.', 'armGroupLabels': ['GLP-1']}, {'name': 'glucose dependent insulinotropic polypeptide', 'type': 'DRUG', 'description': 'continuous infusion of GIP (1½ pmol/kg/min) for 120 min.', 'armGroupLabels': ['GIP']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'continuous infusion of Saline for 120 min', 'armGroupLabels': ['saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Dept. of Endocrinology, Hvidovre Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Patricia V Højberg, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Hvidovre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Patricia Verdugo Højberg/ MD, PHD', 'oldOrganization': 'Kettegaard Alle 30, 2650 Hvidovre'}}}}