Insulin ResistanceSAINPOSNCT01572818
Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients
A study testing phlebotomy and dietary and lifestyle counseling in people with Insulin Resistance and Iron Overload, run by Rennes University Hospital at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Insulin Resistance, Iron Overload
- What is being tested?
- phlebotomy and dietary and lifestyle counseling
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2010to Oct 2015
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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.
- Conditions
- Insulin Resistance, Iron Overload
- Being tested
- phlebotomy, dietary and lifestyle counseling
- Keywords
- Phlebotomy, Insulin Resistance, Iron Overload
- Medical subject headings
- Insulin Resistance, 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.
7 ml/kg without exceeding 500 mL
dietary and lifestyle counselingBehavioural
Also called Non applicable.
dietary and lifestyle counseling
| Study group | Role | What they receive |
|---|---|---|
| Phlebotomy | Experimental | phlebotomy associated with dietary and lifestyle counseling Receives: Procedure: phlebotomy; Behavioral: dietary and lifestyle counseling |
| Lifestyle counseling | Active comparator | dietary and lifestyle counseling Receives: Behavioral: dietary and lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Infusion Rate by euglycemic-hyperinsulinic clamp
Measured: 6 months
Secondary outcomes (9)
hepatic parameters
Measured: 6 months
inflammation markers
IL-6, TNF alpha, CRP
Measured: 6 months
Adipokins markers
adiponectin, PAI1, leptin
Measured: 6 months
SHBG
Measured: 6 months
HOMA-IR
Measured: 6 months
Hepatic iron overload (MRI)
transaminase (ALT, AST), gamma GT
Measured: 6 months
Abdominal and sub-cutaneous fat surface (MRI)
Measured: 6 months
iron parameters
serum iron, ferritin, saturation of transferrin
Measured: at 6 months
lipid profile
HDL-c, LDL-c, triglycerides
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startOct 2010
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice BONNET, MD, PHD, Principal investigator, Rennes University HospitalEric Bellissant, MD, PhD, Study chair, RennesUniversity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572818
- Sponsor's protocol ID
- 2008-A00636-49
- Other IDs
- PHRC/07-05, CIC0203/070
- Acronym
- SAINPOS
- Status last verified
- Jun 2016
- First submitted
- 17 May 2011
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients
- ClinicalTrials.gov ID
- NCT01572818
- Acronym / sponsor ID
- SAINPOS / 2008-A00636-49
- Conditions
- Insulin Resistance, Iron Overload
- Keywords
- Phlebotomy, Insulin Resistance, Iron Overload
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phlebotomy | Experimental | Procedure: phlebotomy, Behavioral: dietary and lifestyle counselingphlebotomy associated with dietary and lifestyle counseling |
| Lifestyle counseling | Active comparator | Behavioral: dietary and lifestyle counselingdietary and lifestyle counseling |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- Other causes of hyperferritinemia:
- Contraindication of phlebotomy
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phlebotomyAlso: Non applicable.7 ml/kg without exceeding 500 mL | Procedure or surgery | Phlebotomy |
| dietary and lifestyle counselingAlso: Non applicable.dietary and lifestyle counseling | Behavioural | Lifestyle counseling, Phlebotomy |
Primary outcome
Glucose Infusion Rate by euglycemic-hyperinsulinic clamp
Time frame: 6 months
9 secondary outcomes
hepatic parameters
Time frame: 6 months
inflammation markers
Time frame: 6 months
Adipokins markers
Time frame: 6 months
SHBG
Time frame: 6 months
HOMA-IR
Time frame: 6 months
Hepatic iron overload (MRI)
Time frame: 6 months
Abdominal and sub-cutaneous fat surface (MRI)
Time frame: 6 months
iron parameters
Time frame: at 6 months
lipid profile
Time frame: at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice BONNET, MD, PHD principal investigator
Rennes University Hospital
Eric Bellissant, MD, PhD study chair
RennesUniversity Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phlebotomy and dietary and lifestyle counseling in people with Insulin Resistance and Iron Overload, run by Rennes University Hospital at 2 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 7 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 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Glucose Infusion Rate by euglycemic-hyperinsulinic clamp (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2016.