Clinical trial NCT02526121: Effect of Therapeutic Phlebotomies on the Triglycerides Concentration in Patients With Hypertriglyceridemia and Hyperferritinemia
Official title: Effect of Therapeutic Phlebotomies on the Triglycerides Concentration in Patients With Hypertriglyceridemia and Hyperferritinemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperferritinemia
Hypertriglyceridemia
Lead sponsor: Instituto Aragones de Ciencias de la Salud
Sponsor class: OTHER_GOV
First posted: 2015-08-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Triglycerides concentration
timeFrame: Three months before
Secondary outcomes:
measure: Iron parameters
timeFrame: Three months before
Other outcomes:
measure: Total cholesterol
timeFrame: Three months before
measure: HDL-cholesterol
timeFrame: Three months before
measure: LDL- cholesterol
timeFrame: Three months before
measure: Apolipoprotein A1
timeFrame: Three months before
measure: Apolipoprotein B
timeFrame: Three months before
measure: Peripheral Insulin resistance measured by HOMA
timeFrame: Three months before
measure: Inflammatory cytokines
timeFrame: Three months before
measure: C Reactive Protein
timeFrame: Three months before
Locations:
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
name: Fernando Civeira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mateo-Gallego R, Lacalle L, Perez-Calahorra S, Marco-Benedi V, Recasens V, Padron N, Lamiquiz-Moneo I, Baila-Rueda L, Jarauta E, Calmarza P, Cenarro A, Civeira F. Efficacy of repeated phlebotomies in hypertriglyceridemia and iron overload: A prospective, randomized, controlled trial. J Clin Lipidol. 2018 Sep-Oct;12(5):1190-1198. doi: 10.1016/j.jacl.2018.06.017. Epub 2018 Jul 4.