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Phlebotomy and Lifestyle and Diet Advices vs Lifestyle and Diet Advices Only in Patients With Dysmetabolic Liversiderosis (SAIGNEES)

This study is currently recruiting participants.
Verified June 2012 by Rennes University Hospital
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01045525
First received: January 8, 2010
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

Insulin resistance-associated hepatic iron overload (IR-HIO), also defined as dysmetabolic iron overload syndrome or dysmetabolic liversiderosis, is a common cause or iron overload in France, mainly in middle-age patients with increased serum ferritin levels associated with normal serum transferrin saturation, and normal serum iron concentration in the absence of other known cause of increased serum ferritin levels.

Treatment includes a combination of dietary measures and physical activity to correct metabolic disorders. Phlebotomies seem to be beneficial when serum ferritin level is high.

This study aims at comparing the effect of iron depletion (by phlebotomy) plus lifestyle and diet advices versus lifestyle and diet advices alone on blood glucose level and insulin sensitivity in subjects with IR-HIO in order to assess the benefits of phlebotomies on the reduction of risk of diabetes and cardiovascular associated complications.


Condition Intervention Phase
Liver Cirrhosis
Iron Overload
 Procedure: Phlebotomy
Behavioral: Lifestyle and diet advices
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Study Comparing the Effect of Phlebotomy and Lifestyle and Diet Advices vs Lifestyle and Diet Advices Only on Glycemia in Patients With Dysmetabolic Liversiderosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Fasting blood glycemia (T0 of Oral Glucose Tolerance Test) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of Body mass index > 25 kg/m² [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of systolic blood pressure ≥ 130mmHg or diastolic blood pressure ≥ 85 mmHg or antihypertensive treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of abdominal obesity (waist measurement ≥ 94 cm for men and ≥ 80 cm for women) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of fasting triglyceridemia ≥ 1.7 mmol/L or triglyceride-lowering treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of fasting HDL cholesterol < 1.03 mmol/L for men and < 1.29 mmol/L for women or HDL cholesterol-elevating treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of fasting glycemia ≥ 5.6 mmol/L [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • HbA1c value [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life estimated with SF36 form and tolerance to treatment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Insulinoresistance indexes calculated at T0 and T30 min of Oral Glucose Tolerance Test (OGTT) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Biological markers: CRP, hyaluronic acid, fibrometer [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • myocardial deformation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Two dimensional (2D) speckle tracking echocardiography (STE)


Estimated Enrollment: 270
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phlebotomy + lifestyle and diet advices Procedure: Phlebotomy
From 300 to 400mL for women; From 350 to 450mL for men
Other Name: Non applicable
Active Comparator: Lifestyle and diet advices Behavioral: Lifestyle and diet advices
2 Booklets with Dietary and physical activity advices
Other Name: Non applicable

Detailed Description:

Non applicable

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 18
  • Signed written informed consent
  • Ferritin ≥ 450 µg/L and ≤ 1500 µg/L
  • Hepatic iron overload proved by MRI or histological biochemical measurement (Iron hepatic concentration ≥ 50 μmol/g)

  • At least one of the following criteria :

    • Body mass index > 25 kg/m²
    • Systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90 mmHg or antihypertensive treatment
    • Abdominal obesity (waist measurement ≥ 94 cm for men and ≥ 80 cm for women)
    • Fasting triglyceridemia ≥ 1.7 mmol/L or triglyceride-lowering treatment
    • Fasting HDL cholesterol < 1.03 mmol/L for men and < 1.29 mmol/L for women or HDL cholesterol-elevating treatment
    • Fasting blood glycemia ≥ 5.6 mmol/L

Exclusion Criteria:

  • Subjects deprived of their liberty by judicial or administrative decision
  • Pregnant women

  • Other causes of increased serum ferritin levels:

    • Inflammatory syndrome (CRP >10 mg/L) or inflammatory, immune or malignant diseases
    • Hyper-hemolysis
    • Alcohol consumption more than 210 g for men and 140 g for women per week within the year before inclusion
    • Haemochromatosis established by the C282Y homozygous genotype
    • Chronic hepatic cytolysis due to : viral infection (HBV, HCV), alcohol, hyperthyroid disease, celiac disease, drug or immune hepatitis
    • Increased serum ferritin levels - cataract syndrome (familial cataract or personal history of cataract before 50 years of age)
    • Low ceruloplasmin level
    • Porphyria (cutaneous signs)

  • Contraindication of phlebotomy

    • Haemoglobin <13 g/dL for men and <12g/dL for women (threshold established by the French Blood Agency)
    • Congestive heart failure or coronary heart disease
    • Hepatic failure (TP<60%), renal failure (GFR <50mL/min) or respiratory insufficiency (chronic dyspnea)
    • Poor venous system
  • Fasting blood glycemia > 7 mmol/L or type 1 or type 2 diabetes, treated or not
  • Use of drugs known to have anti-steatotic effects : metformin, thiazolidinedione
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045525

Contacts
Contact: Fabrice LAINE, MD 33-2-9928-9199 fabrice.laine@chu-rennes.fr

Locations
France
Clermont-Ferrand University Hospital Recruiting
Clermont-Ferrand, France, 63058
Contact: Marc RUIVARD, MD, PhD     33-4-7375-0085     mruivard@chu-clermontferrand.fr    
Principal Investigator: Armand ABERGEL, MD, PhD            
Principal Investigator: Marc RUIVARD, MD, PhD            
La Roche Sur Yon Hospital Recruiting
La Roche Sur Yon, France, 85925
Contact: Roger FAROUX, MD     33-2--5144-6168     gastroenterologie@chd-vendee.fr    
Principal Investigator: Roger FAROUX, MD            
Lorient Hospital Not yet recruiting
Lorient, France, 56100
Contact: Gérard LE DREAU     33-2-9764-9182     g.ledreau@ch-bretagne-sud.fr    
Principal Investigator: Gérard LE DREAU, MD            
Service des maladies du foie - Hôpital Pontchaillou Recruiting
Rennes, France, 35000
Contact: Fabrice LAINE, MD     33-2-9928-9199     fabrice.laine@chu-rennes.fr    
Principal Investigator: Fabrice LAINE, MD            
Sub-Investigator: Yves DEUGNIER, MD, PhD            
Saint-Malo Hospital Recruiting
Saint-Malo, France, 35400
Contact: Christine BEUSNEL     33-2-9921-2783     c.beusnel@ch-stmalo.fr    
Principal Investigator: Christine BEUSNEL, MD            
Sponsors and Collaborators
Rennes University Hospital
Ministry of Health, France
Investigators
Principal Investigator: Fabrice LAINE, MD Rennes University Hospital
Study Chair: Eric BELLISSANT, MD, PhD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01045525     History of Changes
Other Study ID Numbers: EUDRACT 2009-A00831-56, PHRC / 09-02
Study First Received: January 8, 2010
Last Updated: June 6, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
Phlebotomy
Dysmetabolic liversiderosis
Hepatic Iron overload

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Iron Overload
Liver Diseases
 Digestive System Diseases
Pathologic Processes
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013