NCT01572818

Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate efficacy of phlebotomy on insulin sensitivity as evaluated by euglycemic-hyperinsulinic clamp in insulin resistance-associated hepatic iron overload patients.

Detailed description

The main objective of this study is to evaluate in patients with HSD effects of treatment with phlebotomy rules with lifestyle and dietary rules versus lifestyle modifications alone on peripheral insulin resistance (assessed by hyperinsulinemic clamp). Secondary objectives are: * to study in all patients with HSD the relationship between the amount of iron intrahepatic and degree of peripheral insulin resistance and liver before therapeutic intervention. * to study and compare the effects of phlebotomy treatment versus no treatment on: * Plasma levels of adipocytokines, * Plasma concentrations of inflammatory markers and markers of insulin resistance, * The serum ferritin, * The post-hepatic clearance of insulin, * The surface of the abdominal visceral fat and subcutaneous abdominal.

Conditions

• Insulin Resistance
• Iron Overload

Interventions

Type	Name	Description
PROCEDURE	phlebotomy	7 ml/kg without exceeding 500 mL
BEHAVIORAL	dietary and lifestyle counseling	dietary and lifestyle counseling

Timeline

• Start date: 2010-10-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2012-04-06
• Last updated: 2016-06-15

Locations

2 sites across 1 country: France