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| Name | Class |
|---|---|
| Karl and Veronica Carstens Foundation | OTHER |
| University Hospital, Essen | OTHER |
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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 In the intervention group 300-400 ml of venous blood were withdrawn at day 1 and after 4 weeks.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| waiting list control | No Intervention | This group received no specific treatment but was offered treatment after termination of the 6-week study phase |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood letting | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| diastolic blood pressure | change from baseline at 6 weeks | |
| HbA1c | change from baseline at 6 weeks | |
| blood lipids |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Michalsen, Prof., M.D. | Charite-University Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kliniken Essen-Mitte, University Duisburg-Essen | Essen | North-Rhine Westfalia | 45130 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22647517 | Derived | 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. |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D006973 | Hypertension |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D001815 | Bloodletting |
| ID | Term |
|---|---|
| D018962 | Phlebotomy |
| D011677 | Punctures |
| D013812 | Therapeutics |
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| change from baseline at 6 weeks |
| serum ferritin | change from baseline at 6 weeks |
| adiponectin | change from baseline at 6 weeks |
| blood count | change from baseline at 6 weeks |
| serum iron | change from baseline at 6 weeks |
| hs-CRP | change from baseline at 6 weeks |
| pulse rate | change from baseline at 6 weeks |
| serum glucose | change from baseline at 6 weeks |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |