Effects of Blood Letting in Metabolic Syndrome

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

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 In the intervention group 300-400 ml of venous blood were withdrawn at day 1 and after 4 weeks.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

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Procedure: blood letting

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Germany
  • North-Rhine Westfalia
    • Essen, North-Rhine Westfalia, Germany, 45130
      • Kliniken Essen-Mitte, University Duisburg-Essen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.
NO_INTERVENTION: waiting list control; This group received no specific treatment but was offered treatment after termination of the 6-week study phase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
systolic blood pressure	Blood pressure is measured twice after 5 minutes rest in the sitting position by sphygmomanometry	change from baseline at 6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: University Hospital, Essen; Karl and Veronica Carstens Foundation
• Investigators: Principal Investigator: Andreas Michalsen, Prof., M.D., Charite-University Medical Centre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): March 1, 2009
• Study Completion (ACTUAL): May 1, 2009

Study Registration Dates

• First Submitted: March 30, 2011
• First Submitted That Met QC Criteria: April 1, 2011
• First Posted (ESTIMATE): April 4, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 8, 2011
• Last Update Submitted That Met QC Criteria: November 5, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: insulin sensitivity; hypertension; metabolic syndrome; Phlebotomy; blood letting
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 4-2006-AV