Back to resultsEffect of Therapeutic Phlebotomies on the Triglycerides Concentration in Patients With Hypertriglyceridemia and Hyperferritinemia
Primary Purpose
Hyperferritinemia, Hypertriglyceridemia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Phlebotomy
Dietary and lifestyle counseling.
Sponsored by
About this trial
This is an interventional treatment trial for Hyperferritinemia
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitario Miguel Servet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Phlebotomy associated with dietary and lifestyle counseling
Dietary and lifestyle counseling.
Arm Description
Outcomes
Primary Outcome Measures
Triglycerides concentration
Secondary Outcome Measures
Iron parameters
Ferritin level: >300 µgr/L in men and >200 µgr/L in women
Full Information
NCT ID
NCT02526121
First Posted
March 25, 2015
Last Updated
August 29, 2016
Sponsor
Instituto Aragones de Ciencias de la Salud
1. Study Identification
Unique Protocol Identification Number
NCT02526121
Brief Title
Effect of Therapeutic Phlebotomies on the Triglycerides Concentration in Patients With Hypertriglyceridemia and Hyperferritinemia
Official Title
Effect of Therapeutic Phlebotomies on the Triglycerides Concentration in Patients With Hypertriglyceridemia and Hyperferritinemia.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Aragones de Ciencias de la Salud
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperferritinemia, Hypertriglyceridemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phlebotomy associated with dietary and lifestyle counseling
Arm Type
Experimental
Arm Title
Dietary and lifestyle counseling.
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Phlebotomy
Intervention Description
Volume of 400 mL every 3 weeks, 3 times.
Intervention Type
Behavioral
Intervention Name(s)
Dietary and lifestyle counseling.
Intervention Description
Dietary and lifestyle counseling.
Primary Outcome Measure Information:
Title
Triglycerides concentration
Time Frame
Three months before
Secondary Outcome Measure Information:
Title
Iron parameters
Description
Ferritin level: >300 µgr/L in men and >200 µgr/L in women
Time Frame
Three months before
Other Pre-specified Outcome Measures:
Title
Total cholesterol
Time Frame
Three months before
Title
HDL-cholesterol
Time Frame
Three months before
Title
LDL- cholesterol
Time Frame
Three months before
Title
Apolipoprotein A1
Time Frame
Three months before
Title
Apolipoprotein B
Time Frame
Three months before
Title
Peripheral Insulin resistance measured by HOMA
Time Frame
Three months before
Title
Inflammatory cytokines
Time Frame
Three months before
Title
C Reactive Protein
Time Frame
Three months before
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Civeira, MD, PhD
Organizational Affiliation
Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
30049591
Citation
Mateo-Gallego R, Lacalle L, Perez-Calahorra S, Marco-Benedi V, Recasens V, Padron N, Lamiquiz-Moneo I, Baila-Rueda L, Jarauta E, Calmarza P, Cenarro A, Civeira F. Efficacy of repeated phlebotomies in hypertriglyceridemia and iron overload: A prospective, randomized, controlled trial. J Clin Lipidol. 2018 Sep-Oct;12(5):1190-1198. doi: 10.1016/j.jacl.2018.06.017. Epub 2018 Jul 4.
Results Reference
derived
Learn more about this trial
Effect of Therapeutic Phlebotomies on the Triglycerides Concentration in Patients With Hypertriglyceridemia and Hyperferritinemia
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