Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients (SAINPOS)
This study is currently recruiting participants.
Verified April 2012 by Rennes University Hospital
Sponsor:
Rennes University Hospital
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01572818
First received: May 17, 2011
Last updated: April 4, 2012
Last verified: April 2012
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Purpose
The purpose of this study is to evaluate efficacy of phlebotomy on insulin sensitivity as evaluated by euglycemic-hyperinsulinic clamp in insulin resistance-associated hepatic iron overload patients.
| Condition | Intervention |
|---|---|
|
Insulin Resistance Iron Overload |
Procedure: phlebotomy Behavioral: dietary and lifestyle counseling |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients |
Resource links provided by NLM:
Further study details as provided by Rennes University Hospital:
Primary Outcome Measures:
- Glucose Infusion Rate by euglycemic-hyperinsulinic clamp [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- hepatic parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- inflammation markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]IL-6, TNF alpha, CRP
- Adipokins markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]adiponectin, PAI1, leptin
- SHBG [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- HOMA-IR [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Hepatic iron overload (MRI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]transaminase (ALT, AST), gamma GT
- Abdominal and sub-cutaneous fat surface (MRI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- iron parameters [ Time Frame: at 6 months ] [ Designated as safety issue: No ]serum iron, ferritin, saturation of transferrin
- lipid profile [ Time Frame: at 6 months ] [ Designated as safety issue: No ]HDL-c, LDL-c, triglycerides
| Estimated Enrollment: | 48 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Phlebotomy
phlebotomy associated with dietary and lifestyle counseling
|
Procedure: phlebotomy
7 ml/kg without exceeding 500 mL
Other Name: Non applicable.
Behavioral: dietary and lifestyle counseling
dietary and lifestyle counseling
Other Name: Non applicable.
|
|
Active Comparator: Lifestyle counseling
dietary and lifestyle counseling
|
Behavioral: dietary and lifestyle counseling
dietary and lifestyle counseling
Other Name: Non applicable.
|
Detailed Description:
The main objective of this study is to evaluate in patients with HSD effects of treatment with phlebotomy rules with lifestyle and dietary rules versus lifestyle modifications alone on peripheral insulin resistance (assessed by hyperinsulinemic clamp).
Secondary objectives are:
- to study in all patients with HSD the relationship between the amount of iron intrahepatic and degree of peripheral insulin resistance and liver before therapeutic intervention.
to study and compare the effects of phlebotomy treatment versus no treatment on:
- Plasma levels of adipocytokines,
- Plasma concentrations of inflammatory markers and markers of insulin resistance,
- The serum ferritin,
- The post-hepatic clearance of insulin,
- The surface of the abdominal visceral fat and subcutaneous abdominal.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age between 18 and 70 years
- Ferritin between 450 and 1000 µg/L
- Hepatic iron overload proved by MRI (CHF >36 µmol/g)
- Body mass index > 25 kg/m²
- Fasting glycemia <1,26 g/L
- HbA1c < 6,5%
- Signed written and informed consent
Exclusion Criteria:
Other causes of hyperferritinemia:
- Inflammatory syndrome (CRP >10 mg/L) or inflammatory, immune or malignant diseases
- Hyperferritinemia-cataract syndrome (familial cataract or personal history of cataract before 50 years old)
- Low ceruloplasmin level
- Porphyria (cutaneous signs)
- Haemochromatosis established by the genotype (C282Y homozygous or C282Y/H63D coumpound heterozygous genotypes)
Contraindication of phlebotomy
- Haemoglobin <13,5 g/dL (threshold established by the Etablissement Français du Sang)
- Heart failure or coronary heart diseases
- Hepatic failure, renal (GFR <50mL/min) or respiratory insufficiency (chronic dyspnea)
- Poor venous system
- Viral, immune, genetic, vascular, malignant or toxic chronic hepatic disease
- Alcohol consumption more than 21 doses per week during 5 years or more
- Type 1 or type 2 diabetes
- Oral anti-diabetic, corticoids or immune suppressor drugs
- Hepatic severe disease
- Claustrophobia, having a pace-maker or intracerebral clips
- Subjects deprived of their liberty by judicial or administrative decision, subjects that are not affiliated to social security or topics exclusion period of a previous study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572818
Contacts
| Contact: Fabrice BONNET, MD, PHD | fabrice.bonnet@chu-rennes.fr |
Locations
| France | |
| CHU | Not yet recruiting |
| Nantes, France, F-44000 | |
| Contact: Bertrand CARIOU, MD bertrand.cariou@nantes.inserm.fr | |
| Principal Investigator: Bertrand CARIOU, MD, PhD | |
| Sub-Investigator: Nicolas FERRY, MD | |
| CHU | Recruiting |
| Rennes, France, F-35203 | |
| Contact: Fabrice BONNET, MD, PHD fabrice.bonnet@chu-rennes.fr | |
| Contact: Jean-Marc MALECOT, MD jean-marc.malecot@chu-rennes.fr | |
| Sub-Investigator: Jean-Marc MALECOT, MD | |
| Principal Investigator: Fabrice BONNET, MD, PhD | |
| Sub-Investigator: Fabrice LAINE, MD | |
| Sub-Investigator: Yves DEUGNIER, MD, PhD | |
| Sub-Investigator: Nicolas FERRY, MD | |
Sponsors and Collaborators
Rennes University Hospital
Investigators
| Principal Investigator: | Fabrice BONNET, MD, PHD | Rennes University Hospital |
| Study Chair: | Eric Bellissant, MD, PhD | RennesUniversity Hospital |
More Information
No publications provided
| Responsible Party: | Rennes University Hospital |
| ClinicalTrials.gov Identifier: | NCT01572818 History of Changes |
| Other Study ID Numbers: | 2008-A00636-49, PHRC/07-05, CIC0203/070 |
| Study First Received: | May 17, 2011 |
| Last Updated: | April 4, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Rennes University Hospital:
|
Phlebotomy Insulin Resistance Iron Overload |
Additional relevant MeSH terms:
|
Insulin Resistance Iron Overload Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
Iron Metabolism Disorders Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013