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

Primary Purpose

Liver Cirrhosis, Iron Overload

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Phlebotomy
Lifestyle and diet advices
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Phlebotomy, Dysmetabolic liversiderosis, Hepatic Iron overload

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clermont-Ferrand University Hospital
  • La Roche Sur Yon Hospital
  • Lorient Hospital
  • Service des maladies du foie - Hôpital Pontchaillou
  • Saint-Malo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Phlebotomy + lifestyle and diet advices

Lifestyle and diet advices

Arm Description

Outcomes

Primary Outcome Measures

Fasting blood glycemia (T0 of Oral Glucose Tolerance Test)

Secondary Outcome Measures

Rate of Body mass index > 25 kg/m²
Rate of systolic blood pressure ≥ 130mmHg or diastolic blood pressure ≥ 85 mmHg or antihypertensive treatment
Rate of abdominal obesity (waist measurement ≥ 94 cm for men and ≥ 80 cm for women)
Rate of fasting triglyceridemia ≥ 1.7 mmol/L or triglyceride-lowering treatment
Rate of fasting HDL cholesterol < 1.03 mmol/L for men and < 1.29 mmol/L for women or HDL cholesterol-elevating treatment
Rate of fasting glycemia ≥ 5.6 mmol/L
HbA1c value
Quality of life estimated with SF36 form and tolerance to treatment
Insulinoresistance indexes calculated at T0 and T30 min of Oral Glucose Tolerance Test (OGTT)
Biological markers: CRP, hyaluronic acid, fibrometer
myocardial deformation
Two dimensional (2D) speckle tracking echocardiography (STE)

Full Information

First Posted
January 8, 2010
Last Updated
May 22, 2023
Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT01045525
Brief Title
Phlebotomy and Lifestyle and Diet Advices vs Lifestyle and Diet Advices Only in Patients With Dysmetabolic Liversiderosis
Acronym
SAIGNEES
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Non applicable

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Iron Overload
Keywords
Phlebotomy, Dysmetabolic liversiderosis, Hepatic Iron overload

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phlebotomy + lifestyle and diet advices
Arm Type
Experimental
Arm Title
Lifestyle and diet advices
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Phlebotomy
Other Intervention Name(s)
Non applicable
Intervention Description
From 300 to 400mL for women; From 350 to 450mL for men
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle and diet advices
Other Intervention Name(s)
Non applicable
Intervention Description
2 Booklets with Dietary and physical activity advices
Primary Outcome Measure Information:
Title
Fasting blood glycemia (T0 of Oral Glucose Tolerance Test)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Rate of Body mass index > 25 kg/m²
Time Frame
12 months
Title
Rate of systolic blood pressure ≥ 130mmHg or diastolic blood pressure ≥ 85 mmHg or antihypertensive treatment
Time Frame
12 months
Title
Rate of abdominal obesity (waist measurement ≥ 94 cm for men and ≥ 80 cm for women)
Time Frame
12 months
Title
Rate of fasting triglyceridemia ≥ 1.7 mmol/L or triglyceride-lowering treatment
Time Frame
12 months
Title
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
Title
Rate of fasting glycemia ≥ 5.6 mmol/L
Time Frame
12 months
Title
HbA1c value
Time Frame
12 months
Title
Quality of life estimated with SF36 form and tolerance to treatment
Time Frame
12 months
Title
Insulinoresistance indexes calculated at T0 and T30 min of Oral Glucose Tolerance Test (OGTT)
Time Frame
12 months
Title
Biological markers: CRP, hyaluronic acid, fibrometer
Time Frame
12 months
Title
myocardial deformation
Description
Two dimensional (2D) speckle tracking echocardiography (STE)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice LAINE, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric BELLISSANT, MD, PhD
Organizational Affiliation
Rennes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Clermont-Ferrand University Hospital
City
Clermont-Ferrand
ZIP/Postal Code
63058
Country
France
Facility Name
La Roche Sur Yon Hospital
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Lorient Hospital
City
Lorient
ZIP/Postal Code
56100
Country
France
Facility Name
Service des maladies du foie - Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Saint-Malo Hospital
City
Saint-Malo
ZIP/Postal Code
35400
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27685251
Citation
Laine F, Ruivard M, Loustaud-Ratti V, Bonnet F, Cales P, Bardou-Jacquet E, Sacher-Huvelin S, Causse X, Beusnel C, Renault A, Bellissant E, Deugnier Y; Study Group. Metabolic and hepatic effects of bloodletting in dysmetabolic iron overload syndrome: A randomized controlled study in 274 patients. Hepatology. 2017 Feb;65(2):465-474. doi: 10.1002/hep.28856. Epub 2016 Nov 10.
Results Reference
result

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

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