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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01572818
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : June 15, 2016
Information provided by (Responsible Party):
Rennes University Hospital

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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Iron Overload Procedure: phlebotomy Behavioral: dietary and lifestyle counseling Not 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients
Study Start Date : October 2010
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron
Drug Information available for: Insulin

Arm Intervention/treatment
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.

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

Secondary Outcome Measures :
  1. hepatic parameters [ Time Frame: 6 months ]
  2. inflammation markers [ Time Frame: 6 months ]
    IL-6, TNF alpha, CRP

  3. Adipokins markers [ Time Frame: 6 months ]
    adiponectin, PAI1, leptin

  4. SHBG [ Time Frame: 6 months ]
  5. HOMA-IR [ Time Frame: 6 months ]
  6. Hepatic iron overload (MRI) [ Time Frame: 6 months ]
    transaminase (ALT, AST), gamma GT

  7. Abdominal and sub-cutaneous fat surface (MRI) [ Time Frame: 6 months ]
  8. iron parameters [ Time Frame: at 6 months ]
    serum iron, ferritin, saturation of transferrin

  9. lipid profile [ Time Frame: at 6 months ]
    HDL-c, LDL-c, triglycerides

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01572818

Nantes, France, F-44000
Rennes, France, F-35203
Sponsors and Collaborators
Rennes University Hospital
Principal Investigator: Fabrice BONNET, MD, PHD Rennes University Hospital
Study Chair: Eric Bellissant, MD, PhD RennesUniversity Hospital

Responsible Party: Rennes University Hospital Identifier: NCT01572818     History of Changes
Other Study ID Numbers: 2008-A00636-49
PHRC/07-05 ( Other Identifier: Rennes University Hospital )
CIC0203/070 ( Other Identifier: Center for Clinical Research of Rennes )
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016

Keywords provided by Rennes University Hospital:
Insulin Resistance
Iron Overload

Additional relevant MeSH terms:
Insulin Resistance
Iron Overload
Glucose Metabolism Disorders
Metabolic Diseases
Iron Metabolism Disorders
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs