Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-26 @ 2:25 AM
Study NCT ID:
NCT01446302
Status:
COMPLETED
Last Update Posted:
2012-08-14
First Post:
2011-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metabolic and Inflammatory Responses to Hemodialysis and the Effect of a Meal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-13', 'studyFirstSubmitDate': '2011-09-29', 'studyFirstSubmitQcDate': '2011-10-03', 'lastUpdatePostDateStruct': {'date': '2012-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in serum Bioactive IGF-I and IGFBP-1 levels during and after hemodialysis', 'timeFrame': 'At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis'}, {'measure': 'Changes in plasma Interleukin-6 and serum hsCRP levels during and after hemodialysis', 'timeFrame': 'At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis'}], 'secondaryOutcomes': [{'measure': 'Pulse wave analysis (augmentation index (AIx)) during and after hemodialysis', 'timeFrame': 'At 1, 2, 3, ,4, 5, 6, 7, 8, 9, and 10 hours after start of hemodialysis'}, {'measure': 'Mineral metabolism (including calcium, phosphate, PTH, and FGF-23 levels) during and after hemodialysis', 'timeFrame': 'At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dialysis', 'Protein-energy wasting', 'Insulin-Like Growth Factor I', 'Insulin-Like Growth Factor Binding Protein 1', 'Inflammation'], 'conditions': ['Kidney Failure, Chronic']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to characterize the hormonal and inflammatory responses to hemodialysis, and to determine the effect of a meal versus fast on the metabolic changes in the post-dialytic phase.', 'detailedDescription': 'Studies show that hemodialysis (HD) is a protein catabolic event per se and probably contributes to the high prevalence of protein-energy wasting among HD patients. The muscle catabolic effect of HD is probably caused by loss of amino acids (10-12 grams per dialysis session) and by exacerbation of the inflammatory and hormonal disorders already present. Activation of the immune system during HD has been linked to the contact of blood cells with the dialyzer membrane and to bacterial-derived DNA fragments in the dialysis fluid. An intradialytic increase in interleukin-6 (IL-6) has been shown to correlate with muscle protein catabolism, and because IL-6 continues to increase for 2 hours after HD has ended, there might be a considerable "carry-over effect" to the post-dialytic period. Moreover, HD induces significant changes in the insulin/insulin-like growth factor I (IGF-I) signaling pathways. Plasma insulin is cleared by HD, and the bioactivity of IGF-I is reduced by 50% during a 4-hr maintenance HD due to an up-regulation of IGF-binding protein 1 (IGFBP-1), the only acutely regulated IGFBP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* \\> 18 years\n* stable maintenance hemodialysis for at least 3 months\n* well-functioning arteriovenous shunts with recirculation less than 5%\n* informed consent\n\nExclusion criteria:\n\n* diabetes mellitus\n* body mass index below 18.5 or above 30.0 kg/m2\n* malnutrition (global assessment score C)\n* active malignant disease\n* immunosuppressive treatment (including glucocorticoid treatment)\n* evidence of an ongoing inflammatory disease (including infection and autoimmune disorders)\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': 'NCT01446302', 'briefTitle': 'Metabolic and Inflammatory Responses to Hemodialysis and the Effect of a Meal', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Metabolic and Inflammatory Responses to Hemodialysis and the Effect of a Meal', 'orgStudyIdInfo': {'id': 'IGFHD2-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Double meal on a HD day', 'description': 'A standardized meal is served 1 h after start of HD and 1 h after end of HD', 'interventionNames': ['Dietary Supplement: Double meal']}, {'type': 'NO_INTERVENTION', 'label': 'Single meal on a HD day', 'description': 'A standardized meal is served 1 h after start of HD. After the meal participants fast for 9 h (6 h after end of HD).'}, {'type': 'NO_INTERVENTION', 'label': 'Single meal on a non-HD day', 'description': 'A standardized meal is served 1 h after study start. After the meal participants fast for 9 h.'}, {'type': 'NO_INTERVENTION', 'label': 'Single meal (healthy controls)', 'description': 'A standardized meal is served 1 h after study start. After the meal participants fast for 9 h.'}], 'interventions': [{'name': 'Double meal', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A standardized meal is served 1 h after start of HD and 1 h after end of HD.', 'armGroupLabels': ['Double meal on a HD day']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'country': 'Denmark', 'facility': 'Department of Nephrology, Aarhus University Hospital, Skejby', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': '8800', 'city': 'Viborg', 'country': 'Denmark', 'facility': 'Department of Nephrology, Viborg Regional Hospital', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}], 'overallOfficials': [{'name': 'Per Ivarsen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Nephrology, Aarhus University Hospital, Skejby, Denmark'}, {'name': 'Jan Frystyk, MD,PhD,DMSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Endocrinology and Internal Medicine & Medical Research Laboratories, Clinical Institute, Aarhus University Hospital, Denmark'}, {'name': 'Bente Jespersen, MD, DMSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Nephrology, Aarhus University Hospital, Skejby, Denmark'}, {'name': 'Jens S Christiansen, MD, DMSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Endocrinology and Internal Medicine & Medical Research Laboratories, Clinical Institute, Aarhus University Hospital, Denmark'}, {'name': 'Else Randers, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Nephrology, Viborg Regional Hospital, Denmark'}, {'name': 'Mark Reinhard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, Aarhus University Hospital, Skejby, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}