Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-28 @ 8:41 PM
Study NCT ID:
NCT05791968
Status:
COMPLETED
Last Update Posted:
2025-02-21
First Post:
2023-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Donation Could Improve Insulin Sensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'participants in the control group will have the standard blood bank donation venipuncture, but no blood will be withdrawn (sham donation).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, control group, trial (RCT)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2023-03-17', 'studyFirstSubmitQcDate': '2023-03-17', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin sensitivity during an oral glucose tolerance test (OGTT)', 'timeFrame': '7 months', 'description': 'Measured with the calculations of Matsuda index'}, {'measure': 'Ferritin blood level', 'timeFrame': '7 months', 'description': 'iron stores index measured in blood'}, {'measure': 'Turnover rate of endogenous and exogenous glucose', 'timeFrame': '7 months', 'description': 'Measured using isotopic tracers.'}, {'measure': 'Carbohydrate oxidation', 'timeFrame': '7 months', 'description': 'Measured using indirect calorimetry'}, {'measure': 'Continuous glucose monitoring', 'timeFrame': '7 months', 'description': 'Interstitial blood glucose concentrations during 24-h'}], 'secondaryOutcomes': [{'measure': 'Cuality of life', 'timeFrame': '7 months', 'description': 'Measured by SF 12'}, {'measure': 'Fasting lipid profile', 'timeFrame': '7 months', 'description': 'blood analysis'}, {'measure': 'Body composition (weight and body fat)', 'timeFrame': '7 months', 'description': 'TANITA'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ferritin', 'Insulin Sensitivity', 'Blood Donation']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Moreno-Navarrete, J. M., M. Moreno, J. Puig, G. Blasco, F. Ortega, G. Xifra, W. Ricart and J. M. Fernandez-Real (2017).'}, {'type': 'BACKGROUND', 'citation': 'Van Pelt, D. W., S. A. Newsom, S. Schenk and J. F. Horowitz (2015).'}]}, 'descriptionModule': {'briefSummary': 'Studies in the literature suggest that people with obesity have an excess of stored iron. There is possibly an inverse relationship between ferritin levels and the actions of insulin on glycemic control. The reduction of stored iron by simply donating blood could result in improvements in glycemic control in people with obesity and prediabetes. We propose, to reduce ferritin levels through a standard donation of a unit of whole blood, and to measure if it positively affects glycemic control.', 'detailedDescription': 'Individuals with pre-diabetes and abdominal obesity will be randomized to either a donation group (DON) or a control group (CONT) in a double-blind fashion (RCT).\n\nInsulin sensitivity during an oral glucose tolerance test (OGTT) and isotopically measured rate of appearance of endogenous and exogenous glucose will be measured on 2 occasions.\n\n1. Two weeks prior to DON/CONT\n2. Two weeks after to DON/CONT\n\nIndexes of the bodily iron stores will be measured after DON/CONT to evaluate if the primary treatment was effective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have not donated in the last 3 months\n* IMC\\>25\n* fasting blood glucose 100-125 mg/dL\n* glycosylated hemoglobin levels between 5.7-6.4%\n\nExclusion Criteria:\n\n* to not meet donor bank requirements\n* insulin treatment for diabetes\n* anemia\n* hereditary hemochromatosis\n* heart disease\n* familial hypertriglyceridemia or hypobetalipoproteinemia\n* any disease that requires medication that interferes with iron or glucose metabolism'}, 'identificationModule': {'nctId': 'NCT05791968', 'acronym': 'GLUCFER', 'briefTitle': 'Blood Donation Could Improve Insulin Sensitivity', 'organization': {'class': 'OTHER', 'fullName': 'University of Castilla-La Mancha'}, 'officialTitle': 'Effects of a Standard Blood Bank Donation on Insulin Sensitivity in Adults With Pre-diabetes and Abdominal Obesity', 'orgStudyIdInfo': {'id': 'CEIC-CHUT-969'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DONATION GROUP', 'description': 'Participants will be measured before and after a standard blood bank donation (450 mL of whole blood withdrawal)', 'interventionNames': ['Procedure: Whole blood standard donation']}, {'type': 'SHAM_COMPARATOR', 'label': 'CONTROL GROUP', 'description': 'Participants will be measured before and after a sham blood donation (0 mL of whole blood withdrawal)', 'interventionNames': ['Procedure: Whole blood standard donation']}], 'interventions': [{'name': 'Whole blood standard donation', 'type': 'PROCEDURE', 'description': 'Effects of a standard whole blood donation on iron stores and insulin sensitivity.', 'armGroupLabels': ['CONTROL GROUP', 'DONATION GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45071', 'city': 'Toledo', 'state': 'Toledo', 'country': 'Spain', 'facility': 'University of Castilla-La Mancha (Exercise Physiology Lab)', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'data will be shared upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Castilla-La Mancha', 'class': 'OTHER'}, 'collaborators': [{'name': 'SESCAM Centro Regional de Transfusión Toledo-Guadalajara.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Exercise Physiology Laboratory', 'investigatorFullName': 'Ricardo Mora', 'investigatorAffiliation': 'University of Castilla-La Mancha'}}}}