Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-05 @ 6:04 PM
Study NCT ID:
NCT01671969
Status:
COMPLETED
Last Update Posted:
2015-08-28
First Post:
2012-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Very Low Calorie Diet for Diabetic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}], 'ancestors': [{'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': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-27', 'studyFirstSubmitDate': '2012-03-20', 'studyFirstSubmitQcDate': '2012-08-21', 'lastUpdatePostDateStruct': {'date': '2015-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary albumin excretion', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['determine effects of diet on renal and other parameters'], 'conditions': ['Diabetic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '23929927', 'type': 'DERIVED', 'citation': 'Friedman AN, Chambers M, Kamendulis LM, Temmerman J. Short-term changes after a weight reduction intervention in advanced diabetic nephropathy. Clin J Am Soc Nephrol. 2013 Nov;8(11):1892-8. doi: 10.2215/CJN.04010413. Epub 2013 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a very low calorie diet will stabilize or improve diabetic kidney disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 Diabetes\n* Age \\> 18\n* Body mass index ≥ 30\n* Presumed or biopsy-proven diabetic nephropathy\n* Estimated GFR \\< 40 ml/min/1.73 meters squared\n* Proteinuria \\> 0.5 gm/day\n* Motivated to lose weight\n* Stable medical co-morbidities\n* Using an ACE inhibitor or angiotensin receptor blocker agent (unless contraindicated)\n\nExclusion Criteria:\n\n* Inability to sign informed consent\n* Life expectancy of \\< 1 year\n* Expected need for initiation of dialysis within 9 months\n* Type 1 Diabetes\n* Recent myocardial infarction or stroke (past 3 months)\n* Unstable angina\n* Active cancer\n* Pregnancy/lactation\n* Serious psychiatric diseases\n* Substance abuse\n* Uncontrolled hypertension (\\> 180/110)\n* Ineligible for VLCD based on laboratory data'}, 'identificationModule': {'nctId': 'NCT01671969', 'briefTitle': 'Very Low Calorie Diet for Diabetic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'orgStudyIdInfo': {'id': 'VLCD1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'very low calorie diet', 'interventionNames': ['Other: very low calorie diet']}], 'interventions': [{'name': 'very low calorie diet', 'type': 'OTHER', 'description': 'medically supervised diet', 'armGroupLabels': ['very low calorie diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'University Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}