NCT01328210

Brief Summary

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 In the intervention group 300-400 ml of venous blood were withdrawn at day 1 and after 4 weeks.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 4, 2011

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

8 months

First QC Date

March 30, 2011

Last Update Submit

November 5, 2011

Conditions

Metabolic Syndrome

Keywords

metabolic syndromePhlebotomyblood lettinghypertensioninsulin sensitivity

Outcome Measures

Primary Outcomes (2)

  • insulin sensitivity

    Glucose and insulin are measured on the basis of overnight fasting blood samples and Insulin sensitivity calculated according to HOMA-Index

    change from baseline at 6 weeks

  • systolic blood pressure

    Blood pressure is measured twice after 5 minutes rest in the sitting position by sphygmomanometry

    change from baseline at 6 weeks

Secondary Outcomes (10)

  • diastolic blood pressure

    change from baseline at 6 weeks

  • HbA1c

    change from baseline at 6 weeks

  • blood lipids

    change from baseline at 6 weeks

  • serum ferritin

    change from baseline at 6 weeks

  • adiponectin

    change from baseline at 6 weeks

  • +5 more secondary outcomes

Study Arms (2)

blood letting

EXPERIMENTAL

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.

Procedure: blood letting

waiting list control

NO INTERVENTION

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

Interventions

blood lettingPROCEDURE

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.

blood letting

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • given diagnosis of metabolic syndrome

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kliniken Essen-Mitte, University Duisburg-Essen

Essen, North-Rhine Westfalia, 45130, Germany

Location

Related Publications (1)

  • 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.

    PMID: 22647517DERIVED

MeSH Terms

Conditions

Metabolic SyndromeHypertensionInsulin Resistance

Interventions

Bloodletting

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhlebotomyPuncturesTherapeutics

Study Officials

  • Andreas Michalsen, Prof., M.D.

    Charite-University Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

March 30, 2011

First Posted

April 4, 2011

Study Start

July 1, 2008

Primary Completion

March 1, 2009

Study Completion

May 1, 2009

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations

DE(1)