Skip to main content
OpenTrials
Completed

NCT Number: NCT01328210

Effects of Blood Letting in Metabolic Syndrome

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 In the intervention group 300-400 ml of venous blood were withdrawn at day 1 and after 4 weeks.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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolic Syndrome Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Hypertension Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Kliniken Essen-Mitte, University Duisburg-Essen

Essen, North-Rhine Westfalia, 45130, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood letting

Procedure

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.

Primary outcomes

  1. insulin sensitivity

    Time frame: 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

  2. systolic blood pressure

    Time frame: change from baseline at 6 weeks

    Blood pressure is measured twice after 5 minutes rest in the sitting position by sphygmomanometry

Secondary outcomes

  1. diastolic blood pressure

    Time frame: change from baseline at 6 weeks

  2. HbA1c

    Time frame: change from baseline at 6 weeks

  3. blood lipids

    Time frame: change from baseline at 6 weeks

  4. serum ferritin

    Time frame: change from baseline at 6 weeks

  5. adiponectin

    Time frame: change from baseline at 6 weeks

  6. blood count

    Time frame: change from baseline at 6 weeks

  7. serum iron

    Time frame: change from baseline at 6 weeks

  8. hs-CRP

    Time frame: change from baseline at 6 weeks

  9. pulse rate

    Time frame: change from baseline at 6 weeks

  10. serum glucose

    Time frame: change from baseline at 6 weeks

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Karl and Veronica Carstens Foundation
  • University Hospital, Essen

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 4, 2011
Registry last updated
Nov 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.