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

Sponsor
Rennes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01572818
Collaborator
(none)
13
Enrollment
2
Locations
2
Arms
60
Duration (Months)
6.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: phlebotomy
  • Behavioral: dietary and lifestyle counseling
 N/A

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 Design

Study Type:
Interventional
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 :
Oct 1, 2010
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Oct 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phlebotomy

phlebotomy associated with dietary and lifestyle counseling

Procedure: phlebotomy
7 ml/kg without exceeding 500 mL
Other Names:
  • Non applicable.

    • Behavioral: dietary and lifestyle counseling
    dietary and lifestyle counseling
    Other Names:
  • Non applicable.

    		•
    Active Comparator: Lifestyle counseling

    dietary and lifestyle counseling

    Behavioral: dietary and lifestyle counseling
    dietary and lifestyle counseling
    Other Names:
  • Non applicable.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Glucose Infusion Rate by euglycemic-hyperinsulinic clamp [6 months]

    Secondary Outcome Measures

    1. hepatic parameters [6 months]

    2. inflammation markers [6 months]

      IL-6, TNF alpha, CRP

    3. Adipokins markers [6 months]

      adiponectin, PAI1, leptin

    4. SHBG [6 months]

    5. HOMA-IR [6 months]

    6. Hepatic iron overload (MRI) [6 months]

      transaminase (ALT, AST), gamma GT

    7. Abdominal and sub-cutaneous fat surface (MRI) [6 months]

    8. iron parameters [at 6 months]

      serum iron, ferritin, saturation of transferrin

    9. lipid profile [at 6 months]

      HDL-c, LDL-c, triglycerides

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Nantes France F-44000
    2 CHU Rennes France F-35203

    Sponsors and Collaborators

    • Rennes University Hospital

    Investigators

    • Principal Investigator: Fabrice BONNET, MD, PHD, Rennes University Hospital
    • Study Chair: Eric Bellissant, MD, PhD, RennesUniversity Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rennes University Hospital
    ClinicalTrials.gov Identifier:
    NCT01572818
    Other Study ID Numbers:
    • 2008-A00636-49
    • PHRC/07-05
    • CIC0203/070
    First Posted:
    Apr 6, 2012
    Last Update Posted:
    Jun 15, 2016
    Last Verified:
    Jun 1, 2016
    Keywords provided by Rennes University Hospital
    Phlebotomy
    Insulin Resistance
    Iron Overload
    Additional relevant MeSH terms:
    Insulin Resistance
    Iron Overload

    Study Results

    No Results Posted as of Jun 15, 2016