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Liver CirrhosisPhase 3SAIGNEESNCT01045525

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

A Phase 3 study testing Phlebotomy and Lifestyle and diet advices in people with Liver Cirrhosis and Iron Overload, run by Rennes University Hospital at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Cirrhosis, Iron Overload
What is being tested?
Phlebotomy and Lifestyle and diet advices
Could I receive a placebo?
No, everyone receives an active treatment
How many people
274 participants
Where
5 sitesFrance
Study dates
Jan 2010to Dec 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • Clermont-Ferrand University Hospital

    Clermont-Ferrand, 63058

  • La Roche Sur Yon Hospital

    La Roche-sur-Yon, 85925

  • Lorient Hospital

    Lorient, 56100

  • Service des maladies du foie - Hôpital Pontchaillou

    Rennes, 35000

  • Saint-Malo Hospital

    St-Malo, 35400

Other trials in France

About this study

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

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.

Read the detailed description

Non applicable

Being tested
Phlebotomy, Lifestyle and diet advices
Keywords
Phlebotomy, Dysmetabolic liversiderosis, Hepatic Iron overload
Medical subject headings
Liver Cirrhosis, Iron Overload

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PhlebotomyProcedure or surgery

    Also called Non applicable

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

  • Lifestyle and diet advicesBehavioural

    Also called Non applicable

    2 Booklets with Dietary and physical activity advices

Study groups in NCT01045525
Study groupRoleWhat they receive
Phlebotomy + lifestyle and diet advicesExperimentalNot described
Receives: Procedure: Phlebotomy
Lifestyle and diet advicesActive comparatorNot described
Receives: Behavioral: Lifestyle and diet advices

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 months

Secondary outcomes (11)

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

    Measured: 12 months

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

    Measured: 12 months

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

    Measured: 12 months

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

    Measured: 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

    Measured: 12 months

  6. Rate of fasting glycemia ≥ 5.6 mmol/L

    Measured: 12 months

  7. HbA1c value

    Measured: 12 months

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

    Measured: 12 months

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

    Measured: 12 months

  10. Biological markers: CRP, hyaluronic acid, fibrometer

    Measured: 12 months

  11. myocardial deformation

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionJun 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
274 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01045525
Sponsor's protocol ID
EUDRACT 2009-A00831-56
Other IDs
PHRC / 09-02
Acronym
SAIGNEES
Status last verified
May 2023
First submitted
8 Jan 2010
Last updated
23 May 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27685251

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Phlebotomy and Lifestyle and diet advices in people with Liver Cirrhosis and Iron Overload, run by Rennes University Hospital at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting blood glycemia (T0 of Oral Glucose Tolerance Test) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01045525, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.

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