Phlebotomy
ProcedureFrom 300 to 400mL for women; From 350 to 450mL for men
Other names: Non applicable
NCT Number: NCT01045525
Insulin resistance-associated hepatic iron overload (IR-HIO), also defined as dysmetabolic iron overload syndrome or dysmetabolic liversiderosis, is a common cause or iron overload in France, mainly in middle-age patients with increased serum ferritin levels associated with normal serum transferrin saturation, and normal serum iron concentration in the absence of other known cause of increased serum ferritin levels.
Treatment includes a combination of dietary measures and physical activity to correct metabolic disorders. Phlebotomies seem to be beneficial when serum ferritin level is high.
This study aims at comparing the effect of iron depletion (by phlebotomy) plus lifestyle and diet advices versus lifestyle and diet advices alone on blood glucose level and insulin sensitivity in subjects with IR-HIO in order to assess the benefits of phlebotomies on the reduction of risk of diabetes and cardiovascular associated complications.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Clermont-Ferrand University Hospital, Clermont-Ferrand, France
Non applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
From 300 to 400mL for women; From 350 to 450mL for men
Other names: Non applicable
2 Booklets with Dietary and physical activity advices
Other names: Non applicable
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Two dimensional (2D) speckle tracking echocardiography (STE)
Rennes University Hospital
Other
Prospective Randomized Study Comparing the Effect of Phlebotomy and Lifestyle and Diet Advices vs Lifestyle and Diet Advices Only on Glycemia in Patients With Dysmetabolic Liversiderosis
Acronym: SAIGNEES
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
Published trials that share one or more normalized conditions with this study.
NCT07701031
Digestive System Diseases, Fibrosis
Münster, Germany
View Trial DetailsNCT06708832
Digestive System Diseases, Fibrosis
Graz, Austria
View Trial DetailsNCT07625085
Digestive System Diseases, Fibrosis
Rome, Lazio, Italy
View Trial DetailsNCT01082419
Adenocarcinoma, Biliary Cholestasis
Bordeaux, France
View Trial Details