Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-27 @ 11:56 AM
Study NCT ID:
NCT01209403
Status:
COMPLETED
Last Update Posted:
2011-09-30
First Post:
2010-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061267', 'term': 'Insulin Aspart'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-29', 'studyFirstSubmitDate': '2010-09-17', 'studyFirstSubmitQcDate': '2010-09-24', 'lastUpdatePostDateStruct': {'date': '2011-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of glucose and glucose-insulin infusion on plasma IGF-I and IGFBP-1 during hemodialysis', 'timeFrame': 'From 2 h prior to start of hemodialysis to 2 h after end of hemodialysis', 'description': 'All patients are randomly assigned to a hemodialysis session with either i) no infusion, ii) a continuous iv infusion of glucose, and iii) a continuous iv infusion of glucose and shortacting insulin. Each dialysis session will be separated by 2 weeks of wash-out'}], 'secondaryOutcomes': [{'measure': 'Relationship between inflammatory markers and plasma concentrations of IGF-I and IGFBP-1 during hemodialysis', 'timeFrame': 'From 2 h prior to start of hemodialysis to 2 h after end of hemodialysis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dialysis', 'Malnutrition', 'Insulin-Like Growth Factor I', 'Insulin-Like Growth Factor Binding Protein 1', 'Inflammation'], 'conditions': ['Kidney Failure, Chronic']}, 'referencesModule': {'references': [{'pmid': '23557110', 'type': 'DERIVED', 'citation': 'Reinhard M, Frystyk J, Jespersen B, Bjerre M, Christiansen JS, Flyvbjerg A, Ivarsen P. Effect of hyperinsulinemia during hemodialysis on the insulin-like growth factor system and inflammatory biomarkers: a randomized open-label crossover study. BMC Nephrol. 2013 Apr 4;14:80. doi: 10.1186/1471-2369-14-80.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether the anabolic potentials of insulin may be used to reverse the catabolic effects of hemodialysis in non-diabetic patients with end-stage renal failure.', 'detailedDescription': 'Nutritional markers such as lean body mass and serum albumin are strong predictors of the mortality and morbidity in patients with end-stage renal failure (ESRF) on maintenance hemodialysis (HD). Maintenance HD is considered to contribute to the malnutrition of patients with ESRF, but the exact mechanism has remained unknown. However, we have recently shown that the bioactivity of insulin-like growth factor-I (IGF-I) is reduced by 50% during HD. Furthermore, we showed that the reduction in the bioactivity of IGF-I is directly linked to an up-regulation of IGF-binding protein-1 (IGFBP-1), the only acutely regulated IGFBP, which increased by 6-fold during HD. IGFBP-1 is produced in the liver, primarily under the control of insulin, which promptly inhibits the hepatic production of IGFBP-1. As plasma insulin remains fairly low during a maintenance HD, the increase in IGFBP-1 may be explained by the absence of insulin.\n\nThe finding that HD acutely down-regulates the bioactivity of IGF-I by an up-regulation of IGFBP-1 may not only explain the catabolic mechanisms of HD per se, it also opens for a new treatment strategy of ESRF patients undergoing maintenance HD. Thus, on the basis of our previous study we hypothesize that treatment of ERSF patients with high doses of insulin during maintenance HD may counter-act the HD-induced stimulation of IGFBP-1, making it possible to preserve the bioactivity of IGF-I, and thereby abolishing the catabolic impact of HD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years\n* stable patients on maintenance hemodialysis for \\> 3 months\n* well-functioning arteriovenous (AV) shunt with recirculation \\< 5%\n* informed consent\n\nExclusion Criteria:\n\n* diabetes mellitus\n* body mass index \\< 18.5 kg/m2 or \\> 30 kg/m2\n* malnutrition (subjective global assessment (SGA) score C)\n* malignancy\n* use of immunosuppressive drugs including glucocorticosteroids\n* severe infectious disease \\< 4 weeks\n* pregnancy\n\nExclusion Criteria during the study:\n\n* myocardial infarction or arrythmia with hemodynamic derangements\n* permanent thrombosis in the arteriovenous (AV) shunt\n* severe infectious disease\n* renal transplantation'}, 'identificationModule': {'nctId': 'NCT01209403', 'briefTitle': 'Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'IGFHD1-2010'}, 'secondaryIdInfos': [{'id': '2010-020114-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No treatment'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glukose-infusion', 'description': 'Glucose-infusion during hemodialysis', 'interventionNames': ['Drug: Glucose-infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glucose-insulin infusion', 'description': 'Glucose-insulin infusion during hemodialysis', 'interventionNames': ['Drug: Glucose-insulin infusion']}], 'interventions': [{'name': 'Glucose-infusion', 'type': 'DRUG', 'otherNames': ['Glukose'], 'description': 'Continuous iv infusion of glucose', 'armGroupLabels': ['Glukose-infusion']}, {'name': 'Glucose-insulin infusion', 'type': 'DRUG', 'otherNames': ['Glukose', 'Novorapid'], 'description': 'Continuous iv infusion of glucose and shortlasting', 'armGroupLabels': ['Glucose-insulin infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200 N', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Nephrology, Aarhus University Hospital, Skejby', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Per Ivarsen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Nephrology, Aarhus University Hospital, Skejby'}, {'name': 'Jan Frystyk, MD,PhD,DMSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital'}, {'name': 'Bente Jespersen, MD, DMSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Nephrology, Aarhus University Hospital, Skejby'}, {'name': 'Mark Reinhard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, Aarhus University Hospital, Skejby'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}