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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
  Purpose

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 In the intervention group 300-400 ml of venous blood were withdrawn at day 1 and after 4 weeks.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


Condition Intervention Phase
Metabolic Syndrome
 Procedure: blood letting
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Blood Letting on Insulin Sensitivity and Blood Pressure in Patients With Metabolic Syndrome: A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 64
Study Start Date: July 2008
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
No Intervention: waiting list control
This group received no specific treatment but was offered treatment after termination of the 6-week study phase

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328210

Locations
Germany
Kliniken Essen-Mitte, University Duisburg-Essen
Essen, North-Rhine Westfalia, Germany, 45130
Sponsors and Collaborators
Charite University, Berlin, Germany
Karl and Veronica Carstens Foundation
University Hospital, Essen
Investigators
Principal Investigator: Andreas Michalsen, Prof., M.D. Charite-University Medical Centre
  More Information

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Andreas Michalsen, Professor of Medicine, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01328210     History of Changes
Other Study ID Numbers: 4-2006-AV
Study First Received: March 30, 2011
Last Updated: November 5, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
metabolic syndrome
Phlebotomy
blood letting
hypertension
insulin sensitivity

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013