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

Hypertriglyceridemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02526121
• Other study ID #: CEICA;PI10/099
• Status: Completed
• Phase: N/A
• First received: March 25, 2015
• Last updated: August 29, 2016
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Instituto Aragones de Ciencias de la Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperferritinemia
• Hypertriglyceridemia

Intervention

Procedure:
• Phlebotomy
Volume of 400 mL every 3 weeks, 3 times.

Behavioral:
• Dietary and lifestyle counseling.
Dietary and lifestyle counseling.

Locations

Country	Name	City	State
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Aragones de Ciencias de la Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total cholesterol		Three months before	Yes
Other	HDL-cholesterol		Three months before	Yes
Other	LDL- cholesterol		Three months before	Yes
Other	Apolipoprotein A1		Three months before	Yes
Other	Apolipoprotein B		Three months before	Yes
Other	Peripheral Insulin resistance measured by HOMA		Three months before	Yes
Other	Inflammatory cytokines		Three months before	Yes
Other	C Reactive Protein		Three months before	Yes
Primary	Triglycerides concentration		Three months before	Yes
Secondary	Iron parameters	Ferritin level: >300 µgr/L in men and >200 µgr/L in women	Three months before	Yes