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

Rennes University Hospital

Status and phase

Completed

Phase 3

Conditions

Iron Overload

Liver Cirrhosis

Treatments

Behavioral: Lifestyle and diet advices

Procedure: Phlebotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01045525

PHRC / 09-02 (Other Identifier)

EUDRACT 2009-A00831-56

Details and patient eligibility

About

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.

Full description

Non applicable

Enrollment

274 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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