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

Insulin Resistance Clinical Trial

— SAINPOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572818
• Other study ID #: 2008-A00636-49
• Secondary ID: PHRC/07-05CIC020
• Status: Completed
• Phase: N/A
• First received: May 17, 2011
• Last updated: June 14, 2016
• Start date: October 2010
• Est. completion date: October 2015

Study information

• Verified date: June 2016
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance
• Iron Overload

Intervention

Procedure:
• phlebotomy
7 ml/kg without exceeding 500 mL

Behavioral:
• dietary and lifestyle counseling
dietary and lifestyle counseling

Locations

Country	Name	City	State
France	CHU	Nantes
France	CHU	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose Infusion Rate by euglycemic-hyperinsulinic clamp		6 months	No
Secondary	hepatic parameters		6 months	No
Secondary	inflammation markers	IL-6, TNF alpha, CRP	6 months	No
Secondary	Adipokins markers	adiponectin, PAI1, leptin	6 months	No
Secondary	SHBG		6 months	No
Secondary	HOMA-IR		6 months	No
Secondary	Hepatic iron overload (MRI)	transaminase (ALT, AST), gamma GT	6 months	No
Secondary	Abdominal and sub-cutaneous fat surface (MRI)		6 months	No
Secondary	iron parameters	serum iron, ferritin, saturation of transferrin	at 6 months	No
Secondary	lipid profile	HDL-c, LDL-c, triglycerides	at 6 months	No