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

This study is currently recruiting participants.
Verified December 2013 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01572818
First received: May 17, 2011
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Insulin Resistance
Iron Overload
Procedure: phlebotomy
Behavioral: dietary and lifestyle counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Glucose Infusion Rate by euglycemic-hyperinsulinic clamp [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hepatic parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • inflammation markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    IL-6, TNF alpha, CRP

  • Adipokins markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    adiponectin, PAI1, leptin

  • SHBG [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • HOMA-IR [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Hepatic iron overload (MRI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    transaminase (ALT, AST), gamma GT

  • Abdominal and sub-cutaneous fat surface (MRI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • iron parameters [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    serum iron, ferritin, saturation of transferrin

  • lipid profile [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    HDL-c, LDL-c, triglycerides


Estimated Enrollment: 48
Study Start Date: October 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phlebotomy
phlebotomy associated with dietary and lifestyle counseling
Procedure: phlebotomy
7 ml/kg without exceeding 500 mL
Other Name: Non applicable.
Behavioral: dietary and lifestyle counseling
dietary and lifestyle counseling
Other Name: Non applicable.
Active Comparator: Lifestyle counseling
dietary and lifestyle counseling
Behavioral: dietary and lifestyle counseling
dietary and lifestyle counseling
Other Name: Non applicable.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 70 years
  • Ferritin between 450 and 1000 µg/L
  • Hepatic iron overload proved by MRI (CHF >36 µmol/g)
  • Body mass index > 25 kg/m²
  • Fasting glycemia <1,26 g/L
  • HbA1c < 6,5%
  • Signed written and informed consent

Exclusion Criteria:

  • Other causes of hyperferritinemia:

    • Inflammatory syndrome (CRP >10 mg/L) or inflammatory, immune or malignant diseases
    • Hyperferritinemia-cataract syndrome (familial cataract or personal history of cataract before 50 years old)
    • Low ceruloplasmin level
    • Porphyria (cutaneous signs)
    • Haemochromatosis established by the genotype (C282Y homozygous or C282Y/H63D coumpound heterozygous genotypes)
  • Contraindication of phlebotomy

    • Haemoglobin <13,5 g/dL (threshold established by the Etablissement Français du Sang)
    • Heart failure or coronary heart diseases
    • Hepatic failure, renal (GFR <50mL/min) or respiratory insufficiency (chronic dyspnea)
    • Poor venous system
  • Viral, immune, genetic, vascular, malignant or toxic chronic hepatic disease
  • Alcohol consumption more than 21 doses per week during 5 years or more
  • Type 1 or type 2 diabetes
  • Oral anti-diabetic, corticoids or immune suppressor drugs
  • Hepatic severe disease
  • Claustrophobia, having a pace-maker or intracerebral clips
  • Subjects deprived of their liberty by judicial or administrative decision, subjects that are not affiliated to social security or topics exclusion period of a previous study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572818

Contacts
Contact: Fabrice BONNET, MD, PHD fabrice.bonnet@chu-rennes.fr

Locations
France
CHU Not yet recruiting
Nantes, France, F-44000
Contact: Bertrand CARIOU, MD       bertrand.cariou@nantes.inserm.fr   
Principal Investigator: Bertrand CARIOU, MD, PhD         
Sub-Investigator: Nicolas FERRY, MD         
CHU Recruiting
Rennes, France, F-35203
Contact: Fabrice BONNET, MD, PHD       fabrice.bonnet@chu-rennes.fr   
Contact: Jean-Marc MALECOT, MD       jean-marc.malecot@chu-rennes.fr   
Sub-Investigator: Jean-Marc MALECOT, MD         
Principal Investigator: Fabrice BONNET, MD, PhD         
Sub-Investigator: Fabrice LAINE, MD         
Sub-Investigator: Yves DEUGNIER, MD, PhD         
Sub-Investigator: Nicolas FERRY, MD         
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Fabrice BONNET, MD, PHD Rennes University Hospital
Study Chair: Eric Bellissant, MD, PhD RennesUniversity Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01572818     History of Changes
Other Study ID Numbers: 2008-A00636-49, PHRC/07-05, CIC0203/070
Study First Received: May 17, 2011
Last Updated: December 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
Phlebotomy
Insulin Resistance
Iron Overload

Additional relevant MeSH terms:
Insulin Resistance
Iron Overload
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Iron Metabolism Disorders
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014