Clinical trial NCT01328210: Effects of Blood Letting in Metabolic Syndrome
Official title: Effects of Blood Letting on Insulin Sensitivity and Blood Pressure in Patients With Metabolic Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome
Phlebotomy
blood letting
hypertension
insulin sensitivity
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Karl and Veronica Carstens Foundation
name: University Hospital, Essen
First posted: 2011-04-04
Enrollment: 64
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 In the intervention group 300-400 ml of venous blood were withdrawn at day 1 and after 4 weeks.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


Eligibility criteria: 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

Primary outcomes:
measure: insulin sensitivity
timeFrame: change from baseline at 6 weeks
measure: systolic blood pressure
timeFrame: change from baseline at 6 weeks
Secondary outcomes:
measure: diastolic blood pressure
timeFrame: change from baseline at 6 weeks
measure: HbA1c
timeFrame: change from baseline at 6 weeks
measure: blood lipids
timeFrame: change from baseline at 6 weeks
measure: serum ferritin
timeFrame: change from baseline at 6 weeks
measure: adiponectin
timeFrame: change from baseline at 6 weeks
measure: blood count
timeFrame: change from baseline at 6 weeks
measure: serum iron
timeFrame: change from baseline at 6 weeks
measure: hs-CRP
timeFrame: change from baseline at 6 weeks
measure: pulse rate
timeFrame: change from baseline at 6 weeks
measure: serum glucose
timeFrame: change from baseline at 6 weeks
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Kliniken Essen-Mitte, University Duisburg-Essen
state: North-Rhine Westfalia
Study officials:
affiliation: Charite-University Medical Centre
name: Andreas Michalsen, Prof., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.