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
NCT ID: NCT03942432
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2019-06-11
2020-12-04
Brief Summary
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Detailed Description
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In 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patients with dysmetabolic iron overload syndrome
Oral Glucose Tolerance Test (OGTT)
Blood samples at T0, T30min, T120min
Clinical exam
weight, length, waist measurement, cardiac frequency, blood pressure
Blood sample
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
MRI
3 Tesla abdominal MRI
Bioimpedance
Measurement of body composition
Questionnaires
Quality of life, physical activity, alcohol consumption and eating habits
Interventions
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Oral Glucose Tolerance Test (OGTT)
Blood samples at T0, T30min, T120min
Clinical exam
weight, length, waist measurement, cardiac frequency, blood pressure
Blood sample
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
MRI
3 Tesla abdominal MRI
Bioimpedance
Measurement of body composition
Questionnaires
Quality of life, physical activity, alcohol consumption and eating habits
Eligibility Criteria
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Inclusion Criteria
* Persons affiliated to French Social Security
* Persons who received an oral and written information on the protocol and signed the informed consent form
Exclusion Criteria
* Persons deprived of liberty
* Pregnant or breastfeeding women
18 Years
ALL
No
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Locations
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CHU Rennes
Rennes, , France
Countries
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Other Identifiers
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35RC18_8847_EvoHSD
Identifier Type: -
Identifier Source: org_study_id