Status:
COMPLETED
Evaluation of Body Iron Stores in Overweight Healthy Volunteers
Lead Sponsor:
Rennes University Hospital
Conditions:
Healthy Volunteers
Overweight
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Normal body iron store value in overweight subjects is currently not described in literature. The comparison of this value with body iron levels in patients suffering from dysmetabolic iron overload s...
Detailed Description
Normal body iron store value in overweight subjects is currently not described in literature. The comparison of this value with body iron levels in patients suffering from dysmetabolic iron overload s...
Eligibility Criteria
Inclusion
- Male,
- At least 18 years old
- BMI \> 25 Kg/m2
- Serum ferritin level between 100 et 300 µg/L
- Written informed consent
Exclusion
- Blood donations in the past two years
- Alcohol consumption more than 30 g/day
- Inflammatory syndrome (CRP \> 10 mg/L)
- Inflammatory, dysimmunitary or cancerous disease
- Hepatic cytolysis
- Transferrin saturation \> 45%
- Person involved in another clinical trial
- Person with a measure of legal protection (guardianship)
- Person who reached the annual limit for compensation provided by biomedical research
- Hemoglobin \< 13 g/dL
- Uncontrolled heart failure or coronary insufficiency
- Abnormal ECG
- Echocardiographic abnormalities contraindicating phlebotomy
- Hepatic, renal or respiratory insufficiency
- Superficial venous network insufficiency
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT02304874
Start Date
July 1 2011
End Date
August 1 2014
Last Update
May 24 2023
Active Locations (1)
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1
CHU Pontchaillou
Rennes, France, 35000