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

August 29, 2016 updated by: Fernando Civeira, Instituto Aragones de Ciencias de la Salud

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phlebotomy associated with dietary and lifestyle counseling
Procedure: Phlebotomy
Volume of 400 mL every 3 weeks, 3 times.
Behavioral: Dietary and lifestyle counseling.
Dietary and lifestyle counseling.
Active Comparator: Dietary and lifestyle counseling.
Behavioral: Dietary and lifestyle counseling.
Dietary and lifestyle counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Triglycerides concentration
Time Frame: Three months before
Three months before

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Iron parameters
Time Frame: Three months before
Ferritin level: >300 µgr/L in men and >200 µgr/L in women
Three months before

Other Outcome Measures

Outcome Measure
Time Frame
Total cholesterol
Time Frame: Three months before
Three months before
HDL-cholesterol
Time Frame: Three months before
Three months before
LDL- cholesterol
Time Frame: Three months before
Three months before
Apolipoprotein A1
Time Frame: Three months before
Three months before
Apolipoprotein B
Time Frame: Three months before
Three months before
Peripheral Insulin resistance measured by HOMA
Time Frame: Three months before
Three months before
Inflammatory cytokines
Time Frame: Three months before
Three months before
C Reactive Protein
Time Frame: Three months before
Three months before

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Aragones de Ciencias de la Salud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 25, 2015

First Submitted That Met QC Criteria

August 17, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEICA;PI10/099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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