NCT01572818

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
11 months until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

June 15, 2016

Status Verified

June 1, 2016

Enrollment Period

5 years

First QC Date

May 17, 2011

Last Update Submit

June 14, 2016

Conditions

Insulin ResistanceIron Overload

Keywords

PhlebotomyInsulin ResistanceIron Overload

Outcome Measures

Primary Outcomes (1)

  • Glucose Infusion Rate by euglycemic-hyperinsulinic clamp

    6 months

Secondary Outcomes (9)

  • hepatic parameters

    6 months

  • inflammation markers

    6 months

  • Adipokins markers

    6 months

  • SHBG

    6 months

  • HOMA-IR

    6 months

  • +4 more secondary outcomes

Study Arms (2)

Phlebotomy

EXPERIMENTAL

phlebotomy associated with dietary and lifestyle counseling

Procedure: phlebotomyBehavioral: dietary and lifestyle counseling

Lifestyle counseling

ACTIVE COMPARATOR

dietary and lifestyle counseling

Behavioral: dietary and lifestyle counseling

Interventions

phlebotomyPROCEDURE

7 ml/kg without exceeding 500 mL

Also known as: Non applicable.
Phlebotomy
dietary and lifestyle counselingBEHAVIORAL

dietary and lifestyle counseling

Also known as: Non applicable.
Lifestyle counselingPhlebotomy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU

Nantes, F-44000, France

Location

CHU

Rennes, F-35203, France

Location

MeSH Terms

Conditions

Insulin ResistanceIron Overload

Interventions

PhlebotomyDiet

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesIron Metabolism Disorders

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative TechniquesNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Fabrice BONNET, MD, PHD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

  • Eric Bellissant, MD, PhD

    RennesUniversity Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2011

First Posted

April 6, 2012

Study Start

October 1, 2010

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

June 15, 2016

Record last verified: 2016-06

Locations

FR(2)