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

Study Overview
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Brief Summary
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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

Detailed Description
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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. 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.

Official Title
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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

Conditions
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Dysmetabolic Iron Overload Syndrome

Intervention / Treatment
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* Other: Oral Glucose Tolerance Test (OGTT)
* Other: Clinical exam
* Biological: Blood sample
* Device: MRI
* Device: Bioimpedance
* Behavioral: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 subject to major legal protection (safeguarding justice, guardianship, trusteeship) since their enrolment in the Phlebotomy protocol Persons deprived of liberty Pregnant or breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with dysmetabolic iron overload syndrome<br> | Other: Oral Glucose Tolerance Test (OGTT)<br>* Blood samples at T0, T30min, T120min<br>Other: Clinical exam<br>* weight, length, waist measurement, cardiac frequency, blood pressure<br>Biological: Blood sample<br>* 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<br>Device: MRI<br>* 3 Tesla abdominal MRI<br>Device: Bioimpedance<br>* Measurement of body composition<br>Behavioral: Questionnaires<br>* Quality of life, physical activity, alcohol consumption and eating habits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of fasting blood glycemia after 5 years | Oral Glucose Tolerance Test (OGTT) | Year 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of iron hepatic concentration proved by MRI after 5 years | Abdominal MRI | Year 5 | 
| Dosage of iron hepatic concentration after 5 years | Blood sample | Year 5 | 
| Dosage of insulin after 5 years | Blood sample | Year 5 | 
| Measurement of body composition | Bioimpedance | Year 5 | 
| Measurement of insulin resistance markers | Oral Glucose Tolerance Test (OGTT) | Year 5 | 
| Measurement of hepatic steatosis after 5 years | Abdominal MRI | Year 5 | 
| Evaluation of cardiovascular morbi-mortality after 5 years | Mixed score based on the following events: angina pectoris, cardiac arrest, stoke | Year 5 | 
| Calculation of Framingham score | Appreciation of cardiovascular event after 10 years based on blood pressure, cholesterol level and HDL, smoking or not, age and gender | Year 5 | 
| Evaluation of quality of life after 5 years | SF-36 questionnaire | Year 5 | 
| Evaluation of physical activity after 5 years | Baecke physical activity questionnaire : scores for physical exercise in leisure, leisure and locomotion activities | Year 5 | 
| Evaluation of eating habits after 5 years | Eating habits questionnaire | Year 5 | 
| Evaluation of alcohol consumption after 5 years | Alcohol consumption questionnaire : number of units of alcohol consumed per day | Year 5 |