Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-01-01 @ 7:25 PM
Study NCT ID:
NCT01469104
Status:
COMPLETED
Last Update Posted:
2011-11-10
First Post:
2011-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-09', 'studyFirstSubmitDate': '2011-11-08', 'studyFirstSubmitQcDate': '2011-11-09', 'lastUpdatePostDateStruct': {'date': '2011-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in plasma glucose concentration', 'timeFrame': '24 hour profile:before and after meals, or traditional meal times'}], 'secondaryOutcomes': [{'measure': 'Change in serum insulin concentrations', 'timeFrame': '24 hour profiles: before and after meals or traditional meal times'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '27453716', 'type': 'DERIVED', 'citation': 'Nuttall FQ, Almokayyad RM, Gannon MC. The ghrelin and leptin responses to short-term starvation vs a carbohydrate-free diet in men with type 2 diabetes; a controlled, cross-over design study. Nutr Metab (Lond). 2016 Jul 22;13:47. doi: 10.1186/s12986-016-0106-x. eCollection 2016.'}, {'pmid': '25458830', 'type': 'DERIVED', 'citation': 'Nuttall FQ, Almokayyad RM, Gannon MC. Comparison of a carbohydrate-free diet vs. fasting on plasma glucose, insulin and glucagon in type 2 diabetes. Metabolism. 2015 Feb;64(2):253-62. doi: 10.1016/j.metabol.2014.10.004. Epub 2014 Oct 8.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesis is that a carbohydrate-free diet, ingested for 3 days, results in a change in blood glucose that is similar to the change observed after 3 days of fasting.', 'detailedDescription': 'In addition to plasma glucose concentrations, other hormones and metabolites known to be affected by fasting will be measured. These include insulin and glucagon, which are hormones that have an important role in regulating fuel use in the body.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* C-peptide \\> 1.5 ng/ml\n\nExclusion Criteria:\n\n* Body mass index \\> 40\n* hematological abnormalities\n* liver disease\n* kidney disease\n* congestive heart failure\n* life threatening malignancies'}, 'identificationModule': {'nctId': 'NCT01469104', 'acronym': 'CHO-free diet', 'briefTitle': 'Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes', 'organization': {'class': 'FED', 'fullName': 'Minneapolis Veterans Affairs Medical Center'}, 'officialTitle': 'Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes', 'orgStudyIdInfo': {'id': '4177'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '3 day fast', 'description': 'After receiving a standard diet on day 1, subject will fast on days 2, 3, and 4. Water and calorie-fee beverages will be allowed during this 72 hour period.', 'interventionNames': ['Other: 3 day fast']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CHO-free diet', 'description': 'After receiving a standard diet on day 1, a carbohydrate-free diet will be provided on days 2, 3, and 4.', 'interventionNames': ['Other: 3 day CHO-free diet']}], 'interventions': [{'name': '3 day fast', 'type': 'OTHER', 'otherNames': ['3-Day Fast'], 'description': 'Subjects will fast for 72 hours', 'armGroupLabels': ['3 day fast']}, {'name': '3 day CHO-free diet', 'type': 'OTHER', 'otherNames': ['Carbohydrate-free diet'], 'description': 'Subjects will receive a carbohydrate-free diet for 72 hours', 'armGroupLabels': ['CHO-free diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis VA Health Care System', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Frank Q. Nuttall, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minneapolis Veterans Affairs Medical Center'}, {'name': 'Mary C. Gannon, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minneapolis Veterans Affairs Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minneapolis Veterans Affairs Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Endocrinology, Metabolism & Nutrition Section, Professor of Medicine', 'investigatorFullName': 'Frank Q. Nuttall, MD, PhD', 'investigatorAffiliation': 'Minneapolis Veterans Affairs Medical Center'}}}}