An interventional study of Oral Glucose Tolerance Test (OGTT) and Clinical exam in Dysmetabolic Iron Overload Syndrome, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by Rennes University Hospital · Not applicable, Interventional, and Other
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
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.
164 studies on the registry are indexed under Iron Overload; 9 are open to participants now.
This study's enrollment of 75 is above the median of 60 across 106 interventional studies indexed under Iron Overload.
Browse Iron Overload studies →Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Oral Glucose Tolerance Test (OGTT) · Other: Clinical exam · Biological: Blood sample · Device: MRI · Device: Bioimpedance · Behavioral: Questionnaires
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
Dosage of fasting blood glycemia after 5 years
Oral Glucose Tolerance Test (OGTT)
Time frame: Year 5
Dosage of iron hepatic concentration proved by MRI after 5 years
Abdominal MRI
Time frame: Year 5
Dosage of iron hepatic concentration after 5 years
Blood sample
Time frame: Year 5
Dosage of insulin after 5 years
Blood sample
Time frame: Year 5
Measurement of body composition
Bioimpedance
Time frame: Year 5
Measurement of insulin resistance markers
Oral Glucose Tolerance Test (OGTT)
Time frame: Year 5
Measurement of hepatic steatosis after 5 years
Abdominal MRI
Time frame: Year 5
Evaluation of cardiovascular morbi-mortality after 5 years
Mixed score based on the following events: angina pectoris, cardiac arrest, stoke
Time frame: 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
Time frame: Year 5
Evaluation of quality of life after 5 years
SF-36 questionnaire
Time frame: Year 5
Evaluation of physical activity after 5 years
Baecke physical activity questionnaire : scores for physical exercise in leisure, leisure and locomotion activities
Time frame: Year 5
Evaluation of eating habits after 5 years
Eating habits questionnaire
Time frame: Year 5
Evaluation of alcohol consumption after 5 years
Alcohol consumption questionnaire : number of units of alcohol consumed per day
Time frame: Year 5
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Rennes University Hospital