Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-27 @ 12:36 AM
Study NCT ID:
NCT01140932
Status:
COMPLETED
Last Update Posted:
2010-12-08
First Post:
2010-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Electroretinogram in Healthy and Glucose Intolerant Young Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006943', 'term': 'Hyperglycemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'C069727', 'term': 'Sonazoid'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-07', 'studyFirstSubmitDate': '2010-06-08', 'studyFirstSubmitQcDate': '2010-06-09', 'lastUpdatePostDateStruct': {'date': '2010-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ERG', 'timeFrame': '12 days', 'description': 'Characteristics of the scotopic ERG at normo-/hyperglycaemia before vs. after prednisolone treatment'}], 'secondaryOutcomes': [{'measure': 'Retinal Vessel Caliber', 'timeFrame': '12 days', 'description': 'Measurement of retinal vessel caliber from fundus photographs before and after treatment with glucocorticoids.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Retina', 'Electroretinography', 'Diabetes Mellitus', 'Glucose Intolerance', 'Physiology'], 'conditions': ['Electroretinography']}, 'descriptionModule': {'briefSummary': 'The purpose is to investigate the electroretinogram (ERG) in young, healthy men in the normoglycaemic and hyperglycaemic state before and after intervention with corticosteroids treatment, high calorie diet and exercise restraint.', 'detailedDescription': 'The subjects will be fasting from midnight the day before the experiment. Standard procedures (including pupil dilation, dark adaptation, and local anaesthetics) are carried out to allow the ERG to be obtained. After electrophysiology, the subject will be clamped at a plasma glucose level of 10 mM (\\~180 mg/dL) and after a stabilisation period the ERG protocol is repeated.\n\nEach subject is examined twice on two different days. The first day the subjects are normoglycaemic in the morning (first examination) and hyperglycaemic (clamped to 10 mM) throughout the second examination. The second day subjects are also normoglycaemic and hyperglycaemic but shows up after 7-12 days of daily intake of prednisolone, high calorie diet, and exercise restraint.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Caucasians without type 2 diabetes mellitus\n* Normal OGTT (75 g glucose dissolved in 250 mL water) according to WHO's criteria\n* BMI 20-30\n* Haemoglobin \\> 8,0 mM\n\nExclusion Criteria:\n\n* Nephropathy (s-creatinin \\> 130 µM or albuminuria)\n* Relatives (parents or sibling with T2DM)\n* Medical treatment which cannot be paused for 12 hours"}, 'identificationModule': {'nctId': 'NCT01140932', 'briefTitle': 'The Electroretinogram in Healthy and Glucose Intolerant Young Men', 'organization': {'class': 'OTHER', 'fullName': 'Glostrup University Hospital, Copenhagen'}, 'officialTitle': 'Electroretinographic Changes in Healthy Young Men Before and After Induction of Glucose Intolerance by Glucocorticoids Treatment, Hyperphagia and Lack of Exercise', 'orgStudyIdInfo': {'id': 'Kappelgaard, ERG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Medical and behavioural intervention', 'interventionNames': ['Drug: Prednisolone', 'Behavioral: Lifestyle change']}], 'interventions': [{'name': 'Prednisolone', 'type': 'DRUG', 'otherNames': ['Prednisolon DAK, Nycomed, Zurich, Switzerland'], 'description': '12 days of corticosteroids treatment (prednisolone 37,5 mg/day)', 'armGroupLabels': ['Intervention']}, {'name': 'Lifestyle change', 'type': 'BEHAVIORAL', 'otherNames': ['Behavioral regimen'], 'description': 'High calorie diet (130 % of recommended daily energy intake) and relative physical inactivity (no exercise and at least 8 hours of rest/day)', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2600', 'city': 'Copenhagen', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital at Glostrup', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Michael Larsen, MD, DMsc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Glostrup University Hospital, Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Michael Larsen, MD, DMsc', 'oldOrganization': 'Glostrup University Hospital,Copenhagen'}}}}