Effects of Blood Letting in Metabolic Syndrome
- Conditions
- Metabolic Syndrome
- Interventions
- Procedure: blood letting
- Registration Number
- NCT01328210
- Lead Sponsor
- Charite University, Berlin, Germany
- 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 In the intervention group 300-400 ml of venous blood were withdrawn at day 1 and after 4 weeks.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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- 25-70 years of age
- given diagnosis of metabolic syndrome
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description blood letting 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.
- Primary Outcome Measures
Name Time Method insulin sensitivity 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
systolic blood pressure change from baseline at 6 weeks Blood pressure is measured twice after 5 minutes rest in the sitting position by sphygmomanometry
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Kliniken Essen-Mitte, University Duisburg-Essen
🇩🇪Essen, North-Rhine Westfalia, Germany