Metabolic Syndrome
Conditions
Keywords
metabolic syndrome, Phlebotomy, blood letting, hypertension, insulin sensitivity
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 In the intervention group 300-400 ml of venous blood were withdrawn at day 1 and after 4 weeks.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.
Interventions
PROCEDUREblood 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.
Sponsors
Karl and Veronica Carstens Foundation
University Hospital, Essen
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| diastolic blood pressure | 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 |
| serum iron | change from baseline at 6 weeks |
| HbA1c | change from baseline at 6 weeks |
Countries
Germany
Outcome results
None listed