Back to results

Effects of Blood Letting in Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

blood letting

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring metabolic syndrome, Phlebotomy, blood letting, hypertension, insulin sensitivity

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Kliniken Essen-Mitte, University Duisburg-Essen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

blood letting

waiting list control

Arm 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.

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

Outcomes

Primary Outcome Measures

insulin sensitivity

Glucose and insulin are measured on the basis of overnight fasting blood samples and Insulin sensitivity calculated according to HOMA-Index

systolic blood pressure

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

Secondary Outcome Measures

diastolic blood pressure

HbA1c

blood lipids

serum ferritin

adiponectin

blood count

serum iron

hs-CRP

pulse rate

serum glucose

Full Information

NCT ID

NCT01328210

First Posted

March 30, 2011

Last Updated

November 5, 2011

Sponsor

Charite University, Berlin, Germany

Collaborators

Karl and Veronica Carstens Foundation, University Hospital, Essen

1. Study Identification

Unique Protocol Identification Number

NCT01328210

Brief Title

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

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

Collaborators

Karl and Veronica Carstens Foundation, University Hospital, Essen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

Keywords

metabolic syndrome, Phlebotomy, blood letting, hypertension, insulin sensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

blood letting

Arm Type

Experimental

Arm Description

Arm Title

waiting list control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

blood letting

Intervention Description

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 Outcome Measure Information:

Title

insulin sensitivity

Description

Glucose and insulin are measured on the basis of overnight fasting blood samples and Insulin sensitivity calculated according to HOMA-Index

Time Frame