Skip to main content
OpenTrials
Completed

NCT Number: NCT01045525

Phlebotomy and Lifestyle and Diet Advices vs Lifestyle and Diet Advices Only 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clermont-Ferrand University Hospital, Clermont-Ferrand, France

Loading trial locations.

About this study

Non applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phlebotomy

Procedure

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

Other names: Non applicable

Lifestyle and diet advices

Behavioral

2 Booklets with Dietary and physical activity advices

Other names: Non applicable

Primary outcomes

  1. Fasting blood glycemia (T0 of Oral Glucose Tolerance Test)

    Time frame: 12 months

Secondary outcomes

  1. Rate of Body mass index > 25 kg/m²

    Time frame: 12 months

  2. Rate of systolic blood pressure ≥ 130mmHg or diastolic blood pressure ≥ 85 mmHg or antihypertensive treatment

    Time frame: 12 months

  3. Rate of abdominal obesity (waist measurement ≥ 94 cm for men and ≥ 80 cm for women)

    Time frame: 12 months

  4. Rate of fasting triglyceridemia ≥ 1.7 mmol/L or triglyceride-lowering treatment

    Time frame: 12 months

  5. 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

  6. Rate of fasting glycemia ≥ 5.6 mmol/L

    Time frame: 12 months

  7. HbA1c value

    Time frame: 12 months

  8. Quality of life estimated with SF36 form and tolerance to treatment

    Time frame: 12 months

  9. Insulinoresistance indexes calculated at T0 and T30 min of Oral Glucose Tolerance Test (OGTT)

    Time frame: 12 months

  10. Biological markers: CRP, hyaluronic acid, fibrometer

    Time frame: 12 months

  11. myocardial deformation

    Time frame: 12 months

    Two dimensional (2D) speckle tracking echocardiography (STE)

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study 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

Acronym: SAIGNEES

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jan 11, 2010
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.