Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2026-01-25 @ 2:22 AM
Study NCT ID:
NCT03942432
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2019-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Mono-center, Interventional Study Evaluating the Effect of One Year Initial Care by Hygieno-dietary Advices With or Without Phlebotomy on Glycemia After at Least 5 Years in Patients With Dysmetabolic Iron Overload Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005951', 'term': 'Glucose Tolerance Test'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-16', 'studyFirstSubmitDate': '2019-04-26', 'studyFirstSubmitQcDate': '2019-05-06', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dosage of fasting blood glycemia after 5 years', 'timeFrame': 'Year 5', 'description': 'Oral Glucose Tolerance Test (OGTT)'}], 'secondaryOutcomes': [{'measure': 'Dosage of iron hepatic concentration proved by MRI after 5 years', 'timeFrame': 'Year 5', 'description': 'Abdominal MRI'}, {'measure': 'Dosage of iron hepatic concentration after 5 years', 'timeFrame': 'Year 5', 'description': 'Blood sample'}, {'measure': 'Dosage of insulin after 5 years', 'timeFrame': 'Year 5', 'description': 'Blood sample'}, {'measure': 'Measurement of body composition', 'timeFrame': 'Year 5', 'description': 'Bioimpedance'}, {'measure': 'Measurement of insulin resistance markers', 'timeFrame': 'Year 5', 'description': 'Oral Glucose Tolerance Test (OGTT)'}, {'measure': 'Measurement of hepatic steatosis after 5 years', 'timeFrame': 'Year 5', 'description': 'Abdominal MRI'}, {'measure': 'Evaluation of cardiovascular morbi-mortality after 5 years', 'timeFrame': 'Year 5', 'description': 'Mixed score based on the following events: angina pectoris, cardiac arrest, stoke'}, {'measure': 'Calculation of Framingham score', 'timeFrame': 'Year 5', 'description': 'Appreciation of cardiovascular event after 10 years based on blood pressure, cholesterol level and HDL, smoking or not, age and gender'}, {'measure': 'Evaluation of quality of life after 5 years', 'timeFrame': 'Year 5', 'description': 'SF-36 questionnaire'}, {'measure': 'Evaluation of physical activity after 5 years', 'timeFrame': 'Year 5', 'description': 'Baecke physical activity questionnaire : scores for physical exercise in leisure, leisure and locomotion activities'}, {'measure': 'Evaluation of eating habits after 5 years', 'timeFrame': 'Year 5', 'description': 'Eating habits questionnaire'}, {'measure': 'Evaluation of alcohol consumption after 5 years', 'timeFrame': 'Year 5', 'description': 'Alcohol consumption questionnaire : number of units of alcohol consumed per day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dysmetabolic Iron Overload Syndrome']}, 'descriptionModule': {'briefSummary': 'A prospective, mono-center, interventional study evaluating the effect of one year initial care by hygieno-dietary advices with or without Phlebotomy on glycemia after at least 5 years in Patients with dysmetabolic iron overload syndrome', 'detailedDescription': 'Dysmetabolic iron overload syndrome (DIOS) is defined by a slight iron overload associated to features of the metabolic syndrome. This is a frequent condition that parallels the increasing prevalence of non alcoholic steato hepatitis. The role of iron overload on insulin sensitivity is described in large cohorts study, with an increased risk of type 2 diabetes in patients with increased serum ferritin, and in vitro where iron load alters key regulators of lipid and glucose metabolism.\n\nIn patient with DIOS, improving diet and lifestyle is a major goal, albeit it does not allow to lower body iron stores. Therefore the role of bloodletting in this setting was raised. Several low quality studies suggested a beneficial effect of bloodletting on insulin resistance. Our group demonstrated in a large multicenter randomized trial, the lack of beneficial effect of bloodletting over one year. Because this may be a too short period of time to demonstrate a positive effect we would like to assess the long term effect of iron depletion on insulin resistance and its clinical consequence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons who participated in the " Phlebotomy " protocol: A Prospective, Randomized Study Comparing Effect of Phlebotomy and Hygieno-dietary Advices With Hygieno-dietary Advices Only on Glycemia in Patients With Dysmetabolic Iron Overload Syndrome\n* Persons affiliated to French Social Security\n* Persons who received an oral and written information on the protocol and signed the informed consent form\n\nExclusion Criteria:\n\n* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship) since their enrolment in the "Phlebotomy" protocol\n* Persons deprived of liberty\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT03942432', 'acronym': 'EvoHSD', 'briefTitle': 'A Prospective, Mono-center, Interventional Study Evaluating the Effect of One Year Initial Care by Hygieno-dietary Advices With or Without Phlebotomy on Glycemia After at Least 5 Years in Patients With Dysmetabolic Iron Overload Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'A Prospective, Mono-center, Interventional Study Evaluating the Effect of One Year Initial Care by Hygieno-dietary Advices With or Without Phlebotomy on Glycemia After at Least 5 Years in Patients With Dysmetabolic Iron Overload Syndrome', 'orgStudyIdInfo': {'id': '35RC18_8847_EvoHSD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with dysmetabolic iron overload syndrome', 'interventionNames': ['Other: Oral Glucose Tolerance Test (OGTT)', 'Other: Clinical exam', 'Biological: Blood sample', 'Device: MRI', 'Device: Bioimpedance', 'Behavioral: Questionnaires']}], 'interventions': [{'name': 'Oral Glucose Tolerance Test (OGTT)', 'type': 'OTHER', 'description': 'Blood samples at T0, T30min, T120min', 'armGroupLabels': ['Patients with dysmetabolic iron overload syndrome']}, {'name': 'Clinical exam', 'type': 'OTHER', 'description': 'weight, length, waist measurement, cardiac frequency, blood pressure', 'armGroupLabels': ['Patients with dysmetabolic iron overload syndrome']}, {'name': 'Blood sample', 'type': 'BIOLOGICAL', 'description': 'Iron and cardiac markers Serum iron, serum transferrin, transferrin saturation, serum ferritin, AST, ALT, GGT, ALP, PT, Cell Blood Count, ceruloplasminemia , hyaluronic acid, cholesterolemia, HDL, LDL, triglyceridemia, hba1c', 'armGroupLabels': ['Patients with dysmetabolic iron overload syndrome']}, {'name': 'MRI', 'type': 'DEVICE', 'description': '3 Tesla abdominal MRI', 'armGroupLabels': ['Patients with dysmetabolic iron overload syndrome']}, {'name': 'Bioimpedance', 'type': 'DEVICE', 'description': 'Measurement of body composition', 'armGroupLabels': ['Patients with dysmetabolic iron overload syndrome']}, {'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'description': 'Quality of life, physical activity, alcohol consumption and eating habits', 'armGroupLabels': ['Patients with dysmetabolic iron overload syndrome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}