Hyperferritinemia, Hypertriglyceridemia
Conditions
Brief summary
The purpose of this study is to evaluate the effect of iron depletion with phlebotomies on blood triglyceride concentration, in subjects with hypertriglyceridemia and iron overload, compared with a dietary intervention alone. All subjects in this study will follow dietary and lifestyle counseling in a period of 3 months. A randomized group will receive phlebotomies every 3 weeks in this period.
Interventions
PROCEDUREPhlebotomy
Volume of 400 mL every 3 weeks, 3 times.
BEHAVIORALDietary and lifestyle counseling.
Dietary and lifestyle counseling.
Sponsors
Instituto Aragones de Ciencias de la Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Hyperferritinemia: \> 300µgr/L for male and \>200µgr/L for female. * Hypertriglyceridemia: \> 200 mg/dL in two determinations after at least ten hours of fasting and lipid-lowering diet.
Exclusion criteria
* Contraindications for phlebotomy: poor venous access, previous intolerance (hypotension or apprehension), heart disease, anemia. * Subjects suffering from acute or chronic disease, including liver disease, diabetes, cancer, kidney disease or uncontrolled thyroid disease. * Elevated C reactive protein (CRP) as a parameter of inflammation (\>10mg/L). * Alcohol intake: over 30 gr. per day for men and 25 gr. per day for women. * Lipid lowering drugs use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Triglycerides concentration | Three months before |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Iron parameters | Three months before | Ferritin level: \>300 µgr/L in men and \>200 µgr/L in women |
Other
| Measure | Time frame |
|---|---|
| LDL- cholesterol | Three months before |
| Apolipoprotein A1 | Three months before |
| Apolipoprotein B | Three months before |
| Total cholesterol | Three months before |
| Inflammatory cytokines | Three months before |
| C Reactive Protein | Three months before |
| Peripheral Insulin resistance measured by HOMA | Three months before |
| HDL-cholesterol | Three months before |
Countries
Spain
Outcome results
None listed