Effects of Blood Letting in Metabolic Syndrome

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 In the intervention group 300-400 ml of venous blood were withdrawn at day 1 and after 4 weeks.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

Official Title
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Effects of Blood Letting on Insulin Sensitivity and Blood Pressure in Patients With Metabolic Syndrome: A Randomized Controlled Trial

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Procedure: blood letting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: blood letting<br>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<br>* 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.<br>|
| No Intervention: waiting list control<br>This group received no specific treatment but was offered treatment after termination of the 6-week study phase | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic syndrome, Phlebotomy, blood letting, hypertension, insulin sensitivity