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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.

Sponsor: Rennes University Hospital

Current Primary Outcome: Glucose Infusion Rate by euglycemic-hyperinsulinic clamp [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • hepatic parameters [ Time Frame: 6 months ]
  • inflammation markers [ Time Frame: 6 months ]
    IL-6, TNF alpha, CRP
  • Adipokins markers [ Time Frame: 6 months ]
    adiponectin, PAI1, leptin
  • SHBG [ Time Frame: 6 months ]
  • HOMA-IR [ Time Frame: 6 months ]
  • Hepatic iron overload (MRI) [ Time Frame: 6 months ]
    transaminase (ALT, AST), gamma GT
  • Abdominal and sub-cutaneous fat surface (MRI) [ Time Frame: 6 months ]
  • iron parameters [ Time Frame: at 6 months ]
    serum iron, ferritin, saturation of transferrin
  • lipid profile [ Time Frame: at 6 months ]
    HDL-c, LDL-c, triglycerides


Original Secondary Outcome: Same as current

Information By: Rennes University Hospital

Dates:
Date Received: May 17, 2011
Date Started: October 2010
Date Completion:
Last Updated: June 14, 2016
Last Verified: June 2016