CHU Rennes
Rennes, 35033, France
NCT Number: NCT03942432
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Rennes, 35033, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Blood samples at T0, T30min, T120min
weight, length, waist measurement, cardiac frequency, blood pressure
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
3 Tesla abdominal MRI
Measurement of body composition
Quality of life, physical activity, alcohol consumption and eating habits
Time frame: Year 5
Oral Glucose Tolerance Test (OGTT)
Time frame: Year 5
Abdominal MRI
Time frame: Year 5
Blood sample
Time frame: Year 5
Blood sample
Time frame: Year 5
Bioimpedance
Time frame: Year 5
Oral Glucose Tolerance Test (OGTT)
Time frame: Year 5
Abdominal MRI
Time frame: Year 5
Mixed score based on the following events: angina pectoris, cardiac arrest, stoke
Time frame: Year 5
Appreciation of cardiovascular event after 10 years based on blood pressure, cholesterol level and HDL, smoking or not, age and gender
Time frame: Year 5
SF-36 questionnaire
Time frame: Year 5
Baecke physical activity questionnaire : scores for physical exercise in leisure, leisure and locomotion activities
Time frame: Year 5
Eating habits questionnaire
Time frame: Year 5
Alcohol consumption questionnaire : number of units of alcohol consumed per day
Rennes University Hospital
Other
Acronym: EvoHSD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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