Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT01572818
Status:
COMPLETED
Last Update Posted:
2016-06-15
First Post:
2011-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D019190', 'term': 'Iron Overload'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018962', 'term': 'Phlebotomy'}, {'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-14', 'studyFirstSubmitDate': '2011-05-17', 'studyFirstSubmitQcDate': '2012-04-04', 'lastUpdatePostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose Infusion Rate by euglycemic-hyperinsulinic clamp', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'hepatic parameters', 'timeFrame': '6 months'}, {'measure': 'inflammation markers', 'timeFrame': '6 months', 'description': 'IL-6, TNF alpha, CRP'}, {'measure': 'Adipokins markers', 'timeFrame': '6 months', 'description': 'adiponectin, PAI1, leptin'}, {'measure': 'SHBG', 'timeFrame': '6 months'}, {'measure': 'HOMA-IR', 'timeFrame': '6 months'}, {'measure': 'Hepatic iron overload (MRI)', 'timeFrame': '6 months', 'description': 'transaminase (ALT, AST), gamma GT'}, {'measure': 'Abdominal and sub-cutaneous fat surface (MRI)', 'timeFrame': '6 months'}, {'measure': 'iron parameters', 'timeFrame': 'at 6 months', 'description': 'serum iron, ferritin, saturation of transferrin'}, {'measure': 'lipid profile', 'timeFrame': 'at 6 months', 'description': 'HDL-c, LDL-c, triglycerides'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Phlebotomy', 'Insulin Resistance', 'Iron Overload'], 'conditions': ['Insulin Resistance', 'Iron Overload']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate efficacy of phlebotomy on insulin sensitivity as evaluated by euglycemic-hyperinsulinic clamp in insulin resistance-associated hepatic iron overload patients.', 'detailedDescription': 'The main objective of this study is to evaluate in patients with HSD effects of treatment with phlebotomy rules with lifestyle and dietary rules versus lifestyle modifications alone on peripheral insulin resistance (assessed by hyperinsulinemic clamp).\n\nSecondary objectives are:\n\n* to study in all patients with HSD the relationship between the amount of iron intrahepatic and degree of peripheral insulin resistance and liver before therapeutic intervention.\n* to study and compare the effects of phlebotomy treatment versus no treatment on:\n\n * Plasma levels of adipocytokines,\n * Plasma concentrations of inflammatory markers and markers of insulin resistance,\n * The serum ferritin,\n * The post-hepatic clearance of insulin,\n * The surface of the abdominal visceral fat and subcutaneous abdominal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 70 years\n* Ferritin between 450 and 1000 µg/L\n* Hepatic iron overload proved by MRI (CHF \\>36 µmol/g)\n* Body mass index \\> 25 kg/m²\n* Fasting glycemia \\<1,26 g/L\n* HbA1c \\< 6,5%\n* Signed written and informed consent\n\nExclusion Criteria:\n\n* Other causes of hyperferritinemia:\n\n * Inflammatory syndrome (CRP \\>10 mg/L) or inflammatory, immune or malignant diseases\n * Hyperferritinemia-cataract syndrome (familial cataract or personal history of cataract before 50 years old)\n * Low ceruloplasmin level\n * Porphyria (cutaneous signs)\n * Haemochromatosis established by the genotype (C282Y homozygous or C282Y/H63D coumpound heterozygous genotypes)\n* Contraindication of phlebotomy\n\n * Haemoglobin \\<13,5 g/dL (threshold established by the Etablissement Français du Sang)\n * Heart failure or coronary heart diseases\n * Hepatic failure, renal (GFR \\<50mL/min) or respiratory insufficiency (chronic dyspnea)\n * Poor venous system\n* Viral, immune, genetic, vascular, malignant or toxic chronic hepatic disease\n* Alcohol consumption more than 21 doses per week during 5 years or more\n* Type 1 or type 2 diabetes\n* Oral anti-diabetic, corticoids or immune suppressor drugs\n* Hepatic severe disease\n* Claustrophobia, having a pace-maker or intracerebral clips\n* Subjects deprived of their liberty by judicial or administrative decision, subjects that are not affiliated to social security or topics exclusion period of a previous study'}, 'identificationModule': {'nctId': 'NCT01572818', 'acronym': 'SAINPOS', 'briefTitle': 'Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients', 'orgStudyIdInfo': {'id': '2008-A00636-49'}, 'secondaryIdInfos': [{'id': 'PHRC/07-05', 'type': 'OTHER', 'domain': 'Rennes University Hospital'}, {'id': 'CIC0203/070', 'type': 'OTHER', 'domain': 'Center for Clinical Research of Rennes'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phlebotomy', 'description': 'phlebotomy associated with dietary and lifestyle counseling', 'interventionNames': ['Procedure: phlebotomy', 'Behavioral: dietary and lifestyle counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lifestyle counseling', 'description': 'dietary and lifestyle counseling', 'interventionNames': ['Behavioral: dietary and lifestyle counseling']}], 'interventions': [{'name': 'phlebotomy', 'type': 'PROCEDURE', 'otherNames': ['Non applicable.'], 'description': '7 ml/kg without exceeding 500 mL', 'armGroupLabels': ['Phlebotomy']}, {'name': 'dietary and lifestyle counseling', 'type': 'BEHAVIORAL', 'otherNames': ['Non applicable.'], 'description': 'dietary and lifestyle counseling', 'armGroupLabels': ['Lifestyle counseling', 'Phlebotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'F-44000', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': 'F-35203', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Fabrice BONNET, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes University Hospital'}, {'name': 'Eric Bellissant, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'RennesUniversity Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}