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

Insulin Resistance Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance
• Iron Overload

• NCT number: NCT01572818
• Study type: Interventional
• Source: Rennes University Hospital
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Completion date: October 2015