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Effects of Blood Letting in Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborators:
Karl and Veronica Carstens Foundation
University Hospital, Essen
Information provided by (Responsible Party):
Andreas Michalsen, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01328210
First received: March 30, 2011
Last updated: November 5, 2011
Last verified: November 2011
History of Changes

March 30, 2011
November 5, 2011
July 2008
March 2009   (final data collection date for primary outcome measure)
  • insulin sensitivity [ Time Frame: change from baseline at 6 weeks ] [ Designated as safety issue: No ]
    Glucose and insulin are measured on the basis of overnight fasting blood samples and Insulin sensitivity calculated according to HOMA-Index
  • systolic blood pressure [ Time Frame: change from baseline at 6 weeks ] [ Designated as safety issue: No ]
    Blood pressure is measured twice after 5 minutes rest in the sitting position by sphygmomanometry
Same as current
Complete list of historical versions of study NCT01328210 on ClinicalTrials.gov Archive Site
  • diastolic blood pressure [ Time Frame: change from baseline at 6 weeks ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: change from baseline at 6 weeks ] [ Designated as safety issue: No ]
  • blood lipids [ Time Frame: change from baseline at 6 weeks ] [ Designated as safety issue: No ]
  • serum ferritin [ Time Frame: change from baseline at 6 weeks ] [ Designated as safety issue: No ]
  • adiponectin [ Time Frame: change from baseline at 6 weeks ] [ Designated as safety issue: No ]
  • blood count [ Time Frame: change from baseline at 6 weeks ] [ Designated as safety issue: Yes ]
  • serum iron [ Time Frame: change from baseline at 6 weeks ] [ Designated as safety issue: Yes ]
  • hs-CRP [ Time Frame: change from baseline at 6 weeks ] [ Designated as safety issue: No ]
  • pulse rate [ Time Frame: change from baseline at 6 weeks ] [ Designated as safety issue: No ]
  • serum glucose [ Time Frame: change from baseline at 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Blood Letting in Metabolic Syndrome
Effects of Blood Letting on Insulin Sensitivity and Blood Pressure in Patients With Metabolic Syndrome: A Randomized Controlled Trial

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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metabolic Syndrome
Procedure: 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.
  • Experimental: 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.
    Intervention: Procedure: blood letting
  • No Intervention: waiting list control
    This group received no specific treatment but was offered treatment after termination of the 6-week study phase
Houschyar KS, Lüdtke 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
May 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
25 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01328210
4-2006-AV
No
Andreas Michalsen, Charite University, Berlin, Germany
Charite University, Berlin, Germany
  • Karl and Veronica Carstens Foundation
  • University Hospital, Essen
Principal Investigator: Andreas Michalsen, Prof., M.D. Charite-University Medical Centre
Charite University, Berlin, Germany
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP