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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 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: December 24, 2013
Last verified: December 2013

January 8, 2010
December 24, 2013
January 2010
December 2014   (final data collection date for primary outcome measure)
Fasting blood glycemia (T0 of Oral Glucose Tolerance Test) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01045525 on ClinicalTrials.gov Archive Site
  • 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)
  • 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 ]
Not Provided
Not Provided
 
Phlebotomy and Lifestyle and Diet Advices vs Lifestyle and Diet Advices Only in Patients With Dysmetabolic Liversiderosis
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

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.

Non applicable

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Liver Cirrhosis
  • Iron Overload
  • Procedure: Phlebotomy
    From 300 to 400mL for women; From 350 to 450mL for men
    Other Name: Non applicable
  • Behavioral: Lifestyle and diet advices
    2 Booklets with Dietary and physical activity advices
    Other Name: Non applicable
  • Experimental: Phlebotomy + lifestyle and diet advices
    Intervention: Procedure: Phlebotomy
  • Active Comparator: Lifestyle and diet advices
    Intervention: Behavioral: Lifestyle and diet advices
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
270
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Fabrice LAINE, MD 33-2-9928-9199 fabrice.laine@chu-rennes.fr
France
 
NCT01045525
EUDRACT 2009-A00831-56, PHRC / 09-02
Yes
Rennes University Hospital
Rennes University Hospital
Ministry of Health, France
Principal Investigator: Fabrice LAINE, MD Rennes University Hospital
Study Chair: Eric BELLISSANT, MD, PhD Rennes University Hospital
Rennes University Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP