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

Not Applicable

Completed

• Conditions: Hyperferritinemia; Hypertriglyceridemia
• Interventions: Behavioral: Dietary and lifestyle counseling.; Procedure: Phlebotomy

• Registration Number: NCT02526121
• Lead Sponsor: Instituto Aragones de Ciencias de la Salud

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2015-03-25
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-18
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary and lifestyle counseling.	Dietary and lifestyle counseling.	-
Phlebotomy associated with dietary and lifestyle counseling	Phlebotomy	-
Phlebotomy associated with dietary and lifestyle counseling	Dietary and lifestyle counseling.	-

Primary Outcome Measures

Name	Time	Method
Triglycerides concentration	Three months before

Secondary Outcome Measures

Name	Time	Method
Iron parameters	Three months before	Ferritin level: \>300 µgr/L in men and \>200 µgr/L in women

Trial Locations

Locations (1)

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain