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Effects of Blood Letting in Metabolic Syndrome

NCT ID: NCT01328210

Last Updated: 2011-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-05-31

Brief Summary

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Metabolic syndrome (MS) has an increasing prevalence worldwide and there is an urgent need for improvement of medical treatment. In traditional medicine phlebotomy (blood letting) is a recommended treatment for subjects with obesity and vascular disease. Recent studies showed that blood letting with iron depletion may improve insulin sensitivity in patients with diabetes mellitus. The investigators aimed to test if traditional blood letting has beneficial effects in patients with MS. A randomized trial with a sample size of 64 self-referred MS patients was conducted. Patients in the blood letting group were allocated to blood letting intervention and the control group was offered a later treatment (waiting list). In the intervention group 300-400 ml of venous blood were withdrawn at day 1 and after 4 weeks. Primary outcomes were the change of systolic blood pressure and of insulin sensitivity as measured by HOMA-Index.

Detailed Description

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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blood letting

Blood letting was performed immediately after baseline assessment and after 4 weeks. First blood removal consisted of 400ml, second blood removal was tailored according to subsequent serum ferritin levels between 300- 400 ml.

Group Type EXPERIMENTAL

blood letting

Intervention Type PROCEDURE

blood letting twice within 4 weeks. First blood removal baseline with 400ml of venous blood and second blood removal with 300-400ml according to serum ferritin levels.

waiting list control

This group received no specific treatment but was offered treatment after termination of the 6-week study phase

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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blood letting

blood letting twice within 4 weeks. First blood removal baseline with 400ml of venous blood and second blood removal with 300-400ml according to serum ferritin levels.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 25-70 years of age
* given diagnosis of metabolic syndrome

Exclusion Criteria

* clinically significant hepatic, neurological, endocrinologic, or other major systemic or inflammatory disease, including malignancy
* known history of hemochromatosis, or presence of the Cys282Tyr mutation
* history of drug or alcohol abuse
* manifest cardiac disease
* history of disturbances in iron balance (e.g., hemosiderosis from any cause, atransferrinemia)
* preexisting anemia
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karl and Veronica Carstens Foundation

OTHER

Sponsor Role collaborator

University Hospital, Essen

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Andreas Michalsen

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Michalsen, Prof., M.D.

Role: PRINCIPAL_INVESTIGATOR

Charite-University Medical Centre

Locations

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Kliniken Essen-Mitte, University Duisburg-Essen

Essen, North-Rhine Westfalia, Germany

Site Status

Countries

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Germany

References

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Houschyar KS, Ludtke R, Dobos GJ, Kalus U, Broecker-Preuss M, Rampp T, Brinkhaus B, Michalsen A. Effects of phlebotomy-induced reduction of body iron stores on metabolic syndrome: results from a randomized clinical trial. BMC Med. 2012 May 30;10:54. doi: 10.1186/1741-7015-10-54.

Reference Type DERIVED
PMID: 22647517 (View on PubMed)

Other Identifiers

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4-2006-AV

Identifier Type: -

Identifier Source: org_study_id