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Effects of Blood Letting in Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT01328210
Recruitment Status : Completed
First Posted : April 4, 2011
Last Update Posted : November 8, 2011
Information provided by (Responsible Party):

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 In the intervention group 300-400 ml of venous blood were withdrawn at day 1 and after 4 weeks.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

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Procedure: blood letting Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2008
Primary Completion Date : March 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. insulin sensitivity [ Time Frame: change from baseline at 6 weeks ]
    Glucose and insulin are measured on the basis of overnight fasting blood samples and Insulin sensitivity calculated according to HOMA-Index

  2. systolic blood pressure [ Time Frame: change from baseline at 6 weeks ]
    Blood pressure is measured twice after 5 minutes rest in the sitting position by sphygmomanometry

Secondary Outcome Measures :
  1. diastolic blood pressure [ Time Frame: change from baseline at 6 weeks ]
  2. HbA1c [ Time Frame: change from baseline at 6 weeks ]
  3. blood lipids [ Time Frame: change from baseline at 6 weeks ]
  4. serum ferritin [ Time Frame: change from baseline at 6 weeks ]
  5. adiponectin [ Time Frame: change from baseline at 6 weeks ]
  6. blood count [ Time Frame: change from baseline at 6 weeks ]
  7. serum iron [ Time Frame: change from baseline at 6 weeks ]
  8. hs-CRP [ Time Frame: change from baseline at 6 weeks ]
  9. pulse rate [ Time Frame: change from baseline at 6 weeks ]
  10. serum glucose [ Time Frame: change from baseline at 6 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01328210

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
Principal Investigator: Andreas Michalsen, Prof., M.D. Charite-University Medical Centre
More Information

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
First Posted: April 4, 2011    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011

Keywords provided by Andreas Michalsen, Charite University, Berlin, Germany:
metabolic syndrome
blood letting
insulin sensitivity

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs