Effects of Blood Letting in Metabolic Syndrome

Charité University Medicine Berlin

Status and phase: Completed; Phase 2; Phase 1

Conditions: Metabolic Syndrome

Treatments: Procedure: blood letting

Study type: Interventional

Funder types: Other

Identifiers

NCT01328210

4-2006-AV

Details and patient eligibility

About

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 In the intervention group 300-400 ml of venous blood were withdrawn at day 1 and after 4 weeks.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

Enrollment: 64 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

blood letting

Experimental group

Description:

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.

Treatment:

Procedure: blood letting

waiting list control

No Intervention group

Description:

This group received no specific treatment but was offered treatment after termination of the 6-week study phase