Effect of Therapeutic Phlebotomies on the Triglycerides Concentration in Patients With Hypertriglyceridemia and Hyperferritinemia

Instituto Aragones de Ciencias de la Salud60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperferritinemia Hypertriglyceridemia

Interventions

PhlebotomyPROCEDURE

Volume of 400 mL every 3 weeks, 3 times.

Dietary and lifestyle counseling.BEHAVIORAL

Dietary and lifestyle counseling.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitario Miguel Servet

Zaragoza, Spain

Outcomes

Primary Outcomes

Triglycerides concentration

Time frame: Three months before

Secondary Outcomes

Iron parameters

Ferritin level: \>300 µgr/L in men and \>200 µgr/L in women

Time frame: Three months before

Data from ClinicalTrials.gov

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