Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-27 @ 11:19 PM
Study NCT ID:
NCT00438503
Status:
COMPLETED
Last Update Posted:
2015-09-15
First Post:
2007-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glucose in Dialysis Water in Diabetics With Chronic Renal Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D003928', 'term': 'Diabetic Nephropathies'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-14', 'studyFirstSubmitDate': '2007-02-20', 'studyFirstSubmitQcDate': '2007-02-21', 'lastUpdatePostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect og glucose in dialysis water on blood pressure, plasma glucose and hormones in plasma'}], 'secondaryOutcomes': [{'measure': 'Relationship between changes in blood pressure and and changes in hormones'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemodialysis, diabetes mellitus,', 'Chronic renal failure, dialysis ,'], 'conditions': ['Renal Failure, Chronic', 'Diabetic Nephropathies']}, 'descriptionModule': {'briefSummary': 'The purposes are 1. to measure the effect of dialysis with glucose in dialysis water on blood pressure, pulse rate, plasma concentration of glucose, plasma concentrations og insulin, glucagon, growth hormone, renin, angiotensin II, endothelin and body temperature, and 2. to analyse the relationship between the changes in blood pressure and changes in vasoactive hormones', 'detailedDescription': 'The relationship between blood pressure during dialysis treatment and vasoactive hormones are studied. This includes measurements of plasma concentration of glucose, plasma concentrations og insulin, glucagon, growth hormone, renin, angiotensin II, endothelin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 18 years,\n2. Both men and women,\n3. Dialysis treatment for at least three month due to diabetic nephropathy\n\nExclusion Criteria:\n\n1. Heart failure,\n2. Lung insufficiency,\n3. Chronic liver disease,\n4. Malignant disease,\n5. Nephrotic syndrome,\n6. Lack of compliance,\n7. Unwillingness to participate'}, 'identificationModule': {'nctId': 'NCT00438503', 'briefTitle': 'Glucose in Dialysis Water in Diabetics With Chronic Renal Failure', 'organization': {'class': 'OTHER', 'fullName': 'Regional Hospital Holstebro'}, 'officialTitle': 'Effect of Glucose in Dialysis Water in Diabetics With Chronic Renal Failure on Blood Pressure, Pulse Rate, Plasma Glucose, Plasma Concentrations of Insulin, Growth Hormone, Renin, Angiotensin II, Endothelin and Body Temperature', 'orgStudyIdInfo': {'id': 'MED.RES.2007.02.EBP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Procedure', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7500', 'city': 'Holstebro', 'country': 'Denmark', 'facility': 'Holstebro Hospital', 'geoPoint': {'lat': 56.36009, 'lon': 8.61607}}], 'overallOfficials': [{'name': 'Erling B Pedersen, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Regional Hospital Holstebro'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regional Hospital Holstebro', 'class': 'OTHER'}}}}