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

Instituto Aragones de Ciencias de la Salud

Status

Completed

Conditions

Hypertriglyceridemia

Hyperferritinemia

Treatments

Behavioral: Dietary and lifestyle counseling.

Procedure: Phlebotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02526121

CEICA PI10/099;

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.