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Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients (SAINPOS)

Primary Purpose

Insulin Resistance, Iron Overload

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

phlebotomy

dietary and lifestyle counseling

About this trial

This is an interventional treatment trial for Insulin Resistance focused on measuring Phlebotomy, Insulin Resistance, Iron Overload

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Phlebotomy

Lifestyle counseling

Arm Description

phlebotomy associated with dietary and lifestyle counseling

dietary and lifestyle counseling

Outcomes

Primary Outcome Measures

Glucose Infusion Rate by euglycemic-hyperinsulinic clamp

Secondary Outcome Measures

hepatic parameters

inflammation markers

IL-6, TNF alpha, CRP

Adipokins markers

adiponectin, PAI1, leptin

SHBG

HOMA-IR

Hepatic iron overload (MRI)

transaminase (ALT, AST), gamma GT

Abdominal and sub-cutaneous fat surface (MRI)

iron parameters

serum iron, ferritin, saturation of transferrin

lipid profile

HDL-c, LDL-c, triglycerides

Full Information

NCT ID

NCT01572818

First Posted

May 17, 2011

Last Updated

June 14, 2016

Sponsor

Rennes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01572818

Brief Title

Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients

Acronym

SAINPOS

Official Title

Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rennes University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insulin Resistance, Iron Overload

Keywords

Phlebotomy, Insulin Resistance, Iron Overload

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phlebotomy

Arm Type

Experimental

Arm Description

phlebotomy associated with dietary and lifestyle counseling

Arm Title

Lifestyle counseling

Arm Type

Active Comparator

Arm Description

dietary and lifestyle counseling

Intervention Type

Procedure

Intervention Name(s)

phlebotomy

Other Intervention Name(s)

Non applicable.

Intervention Description

7 ml/kg without exceeding 500 mL

Intervention Type

Behavioral

Intervention Name(s)

dietary and lifestyle counseling

Other Intervention Name(s)

Non applicable.

Intervention Description

dietary and lifestyle counseling

Primary Outcome Measure Information:

Title

Glucose Infusion Rate by euglycemic-hyperinsulinic clamp

Time Frame

6 months

Secondary Outcome Measure Information:

Title

hepatic parameters

Time Frame

6 months

Title

inflammation markers

Description

IL-6, TNF alpha, CRP

Time Frame

6 months

Title

Adipokins markers

Description

adiponectin, PAI1, leptin

Time Frame

6 months

Title

SHBG

Time Frame

6 months

Title

HOMA-IR

Time Frame

6 months

Title

Hepatic iron overload (MRI)

Description

transaminase (ALT, AST), gamma GT

Time Frame

6 months

Title

Abdominal and sub-cutaneous fat surface (MRI)

Time Frame

6 months

Title

iron parameters

Description

serum iron, ferritin, saturation of transferrin

Time Frame

at 6 months

Title

lipid profile

Description

HDL-c, LDL-c, triglycerides

Time Frame

at 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fabrice BONNET, MD, PHD

Organizational Affiliation

Rennes University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Eric Bellissant, MD, PhD

Organizational Affiliation

RennesUniversity Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

CHU

City

Nantes

ZIP/Postal Code

F-44000

Country

France

Facility Name

CHU

City

Rennes

ZIP/Postal Code

F-35203

Country

France

12. IPD Sharing Statement

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Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients

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