Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-30 @ 6:16 AM
Study NCT ID:
NCT00497133
Status:
COMPLETED
Last Update Posted:
2008-06-04
First Post:
2007-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alpha-Cell Sensitivity to GLP-1 in Patients With 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': 'Blood for further analyzes and buffy coat'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-03', 'studyFirstSubmitDate': '2007-07-05', 'studyFirstSubmitQcDate': '2007-07-05', 'lastUpdatePostDateStruct': {'date': '2008-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glucoseintolerance'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Glucagon-like peptide 1 is known to improve sensitivity of the pancreatic beta-cell. Further it inhibit secretion from the pancreatic alpha-cell by mechanisms not fully understand. With this study we wish to elucidate the potential of GLP-1 to increase the sensitivity of the alpha-cell.\n\nType 2 diabetic patients and control subjects receive infusions of GLP-1 in increasing doses or saline, alpha- and beta-cell responses are measured in blood-samples. During the study plasma-glucose levels are clamped at fasting levels.\n\nWith this study we hope to elucidate the pathophysiology behind defect glucose tolerance in type 2 diabetes mellitus and further more the potential of GLP-1 in treatment of type 2 diabetes mellitus.', 'detailedDescription': 'Background: Glucagon-like peptide-1 (GLP-1) possesses insulinotropic and glucagonostatic properties, and, therefore, GLP-based antidiabetic therapies have been developed. Even though the insulinotropic potency of GLP-1 has been shown to be reduced in patients with type 2 diabetes mellitus (T2DM), a small dose of GLP-1 is capable of normalizing the beta-cell responsiveness to glucose in these patients. The glucagonostatic potency of GLP-1 in patients with T2DM is not known, and, furthermore, the capability of GLP-1 to reestablish normal glucagon secretion in these patients remains to be elucidated.\n\nObjective: To investigate the alpha-cell sensitivity to GLP-1 in patients with T2DM and to establish if GLP-1 is able to reestablish normal glucagon secretion in such patients.\n\nMethod: Ten patients with T2DM and ten healthy control subjects are clamped at their fasting blood glucose levels during GLP-1 infusions at increasing doses (0.25, 0.5, 1.0 and 2.0 pmol/kg/min) and placebo, respectively. Furthermore, the patients will be hospitalized overnight while receiving intravenous insulin and thereafter examined under normoglycaemic conditions. Blood are being drawn for analysis of plasma insulin, C-peptide, GLP-1 and glucagon.\n\nExpected results and conclusions: We expect that GLP-1 will inhibit glucagon secretion in a dose dependent manner, leading too an increase in glucose turn-over. The results will potentially elucidate the interaction between GLP-1 and glucagon secretion and thereby broaden our knowledge on the pathophysiology of T2DM. Furthermore, the present study will determine the therapeutic impact of GLP-1 on the alpha-cell deficiency characterizing patients with T2DM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'studyPopulation': 'Patients with type 2 diabetes mellitus and matched control subjects.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed oral and written consent\n* Caucasians aged \\> 18 years diagnosed with T2DM due to WHO criteria.\n* Normal haemoglobin\n* HbA1c 6-10%\n* BMI 23-35 kg/m2\n\nExclusion Criteria:\n\n* Hepatic disease, ALAT \\> 2 x normal.\n* Diabetic nephropathy, (S-creatinine \\>130μM or albuminuria).\n* Diabetic neuropathy (reported)\n* Proliferative diabetic retinopathy (reported)\n* Medical treatment that cannot be paused for 12 hours\n* Insulin- or glitazon treatment'}, 'identificationModule': {'nctId': 'NCT00497133', 'briefTitle': 'Alpha-Cell Sensitivity to GLP-1 in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'orgStudyIdInfo': {'id': 'H-KA-20070023'}}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2900', 'city': 'Gentofte Municipality', 'state': 'Hellerup', 'country': 'Denmark', 'facility': 'Gentofte Hostital, Dep. og Internal Medicin F', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}], 'overallOfficials': [{'name': 'Jens Juul Holst, Professor, MD,MMSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Copenhagen, Department of Biomedical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, {'name': 'The Danish Diabetes Association', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'K. J. Hare', 'oldOrganization': 'Gentofte University Hospital, University of Copenhagen.'}}}}