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Completed

NCT Number: NCT02526121

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

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.

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Key information

Conditions

Hyperferritinemia Dyslipidemias Hyperlipidemias Hypertriglyceridemia Iron Metabolism Disorders Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Phlebotomy

Procedure

Volume of 400 mL every 3 weeks, 3 times.

Dietary and lifestyle counseling.

Behavioral

Dietary and lifestyle counseling.

Primary outcomes

  1. Triglycerides concentration

    Time frame: Three months before

Secondary outcomes

  1. Iron parameters

    Time frame: Three months before

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

Other outcomes

  1. Total cholesterol

    Time frame: Three months before

  2. HDL-cholesterol

    Time frame: Three months before

  3. LDL- cholesterol

    Time frame: Three months before

  4. Apolipoprotein A1

    Time frame: Three months before

  5. Apolipoprotein B

    Time frame: Three months before

  6. Peripheral Insulin resistance measured by HOMA

    Time frame: Three months before

  7. Inflammatory cytokines

    Time frame: Three months before

  8. C Reactive Protein

    Time frame: Three months before

Sponsors and collaborators

Lead sponsor

Instituto Aragones de Ciencias de la Salud

Other Gov

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 18, 2015
Registry last updated
Aug 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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