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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2015 by Rennes University Hospital.
Recruitment status was:  Active, not recruiting
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: July 21, 2015
Last verified: July 2015
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

Secondary Outcome Measures:
  • Rate of Body mass index > 25 kg/m² [ Time Frame: 12 months ]
  • Rate of systolic blood pressure ≥ 130mmHg or diastolic blood pressure ≥ 85 mmHg or antihypertensive treatment [ Time Frame: 12 months ]
  • Rate of abdominal obesity (waist measurement ≥ 94 cm for men and ≥ 80 cm for women) [ Time Frame: 12 months ]
  • Rate of fasting triglyceridemia ≥ 1.7 mmol/L or triglyceride-lowering treatment [ Time Frame: 12 months ]
  • 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 ]
  • Rate of fasting glycemia ≥ 5.6 mmol/L [ Time Frame: 12 months ]
  • HbA1c value [ Time Frame: 12 months ]
  • Quality of life estimated with SF36 form and tolerance to treatment [ Time Frame: 12 months ]
  • Insulinoresistance indexes calculated at T0 and T30 min of Oral Glucose Tolerance Test (OGTT) [ Time Frame: 12 months ]
  • Biological markers: CRP, hyaluronic acid, fibrometer [ Time Frame: 12 months ]
  • myocardial deformation [ Time Frame: 12 months ]
    Two dimensional (2D) speckle tracking echocardiography (STE)


Estimated Enrollment: 270
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045525

Locations
France
Clermont-Ferrand University Hospital
Clermont-Ferrand, France, 63058
La Roche Sur Yon Hospital
La Roche Sur Yon, France, 85925
Lorient Hospital
Lorient, France, 56100
Service des maladies du foie - Hôpital Pontchaillou
Rennes, France, 35000
Saint-Malo Hospital
Saint-Malo, France, 35400
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

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01045525     History of Changes
Other Study ID Numbers: EUDRACT 2009-A00831-56
PHRC / 09-02 ( Other Identifier: Sponsor )
Study First Received: January 8, 2010
Last Updated: July 21, 2015

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

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

ClinicalTrials.gov processed this record on August 18, 2017