Effects of Blood Letting in Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328210
• Other study ID #: 4-2006-AV
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 30, 2011
• Last updated: November 5, 2011
• Start date: July 2008
• Est. completion date: May 2009

Study information

• Verified date: November 2011
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

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 In the intervention group 300-400 ml of venous blood were withdrawn at day 1 and after 4 weeks.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Procedure:
• blood 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.

Locations

Country	Name	City	State
Germany	Kliniken Essen-Mitte, University Duisburg-Essen	Essen	North-Rhine Westfalia

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Karl and Veronica Carstens Foundation, University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	systolic blood pressure	Blood pressure is measured twice after 5 minutes rest in the sitting position by sphygmomanometry	change from baseline at 6 weeks	No
Secondary	diastolic blood pressure		change from baseline at 6 weeks	No
Secondary	HbA1c		change from baseline at 6 weeks	No
Secondary	blood lipids		change from baseline at 6 weeks	No
Secondary	serum ferritin		change from baseline at 6 weeks	No
Secondary	adiponectin		change from baseline at 6 weeks	No
Secondary	blood count		change from baseline at 6 weeks	Yes
Secondary	serum iron		change from baseline at 6 weeks	Yes
Secondary	hs-CRP		change from baseline at 6 weeks	No
Secondary	pulse rate		change from baseline at 6 weeks	No
Secondary	serum glucose		change from baseline at 6 weeks	No