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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Non applicable

Conditions

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Liver Cirrhosis Iron Overload

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phlebotomy + lifestyle and diet advices

Group Type EXPERIMENTAL

Phlebotomy

Intervention Type PROCEDURE

From 300 to 400mL for women; From 350 to 450mL for men

Lifestyle and diet advices

Group Type ACTIVE_COMPARATOR

Lifestyle and diet advices

Intervention Type BEHAVIORAL

2 Booklets with Dietary and physical activity advices

Interventions

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Phlebotomy

From 300 to 400mL for women; From 350 to 450mL for men

Intervention Type PROCEDURE

Lifestyle and diet advices

2 Booklets with Dietary and physical activity advices

Intervention Type BEHAVIORAL

Other Intervention Names

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Non applicable Non applicable

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No