Metabolic SyndromePhase 1/2NCT01328210
Effects of Blood Letting in Metabolic Syndrome
A Phase 1/2 study testing blood letting in people with Metabolic Syndrome, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- blood letting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2008to May 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 25-70 years of age
- given diagnosis of metabolic syndrome
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Kliniken Essen-Mitte, University Duisburg-Essen
Essen, North-Rhine Westfalia, 45130
About this study
Official title: 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.
- Conditions
- Metabolic Syndrome
- Being tested
- blood letting
- Keywords
- metabolic syndrome, Phlebotomy, blood letting, hypertension, insulin sensitivity
- Medical subject headings
- Metabolic Syndrome, Hypertension, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood lettingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| blood letting | Experimental | 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. Receives: Procedure: blood letting |
| waiting list control | No intervention | This group received no specific treatment but was offered treatment after termination of the 6-week study phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity
Glucose and insulin are measured on the basis of overnight fasting blood samples and Insulin sensitivity calculated according to HOMA-Index
Measured: change from baseline at 6 weeks
systolic blood pressure
Blood pressure is measured twice after 5 minutes rest in the sitting position by sphygmomanometry
Measured: change from baseline at 6 weeks
Secondary outcomes (10)
diastolic blood pressure
Measured: change from baseline at 6 weeks
HbA1c
Measured: change from baseline at 6 weeks
blood lipids
Measured: change from baseline at 6 weeks
serum ferritin
Measured: change from baseline at 6 weeks
adiponectin
Measured: change from baseline at 6 weeks
blood count
Measured: change from baseline at 6 weeks
serum iron
Measured: change from baseline at 6 weeks
hs-CRP
Measured: change from baseline at 6 weeks
pulse rate
Measured: change from baseline at 6 weeks
serum glucose
Measured: change from baseline at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startJul 2008
- Primary completionMar 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Karl and Veronica Carstens Foundation, University Hospital, Essen
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, Prof., M.D., Principal investigator, Charite-University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328210
- Sponsor's protocol ID
- 4-2006-AV
- Status last verified
- Nov 2011
- First submitted
- 30 Mar 2011
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22647517
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Letting on Insulin Sensitivity and Blood Pressure in Patients With Metabolic Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01328210
- Acronym / sponsor ID
- 4-2006-AV
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, Phlebotomy, blood letting, hypertension, insulin sensitivity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Karl and Veronica Carstens Foundation, University Hospital, Essen
- Study start
- Jul 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 4 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| blood letting | Experimental | Procedure: blood lettingBlood 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. |
| waiting list control | No intervention | –This group received no specific treatment but was offered treatment after termination of the 6-week study phase |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 25-70 years of age
- given diagnosis of metabolic syndrome
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood lettingblood 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. | Procedure or surgery | blood letting |
Primary outcome
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
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
10 secondary outcomes
diastolic blood pressure
Time frame: change from baseline at 6 weeks
HbA1c
Time frame: change from baseline at 6 weeks
blood lipids
Time frame: change from baseline at 6 weeks
serum ferritin
Time frame: change from baseline at 6 weeks
adiponectin
Time frame: change from baseline at 6 weeks
blood count
Time frame: change from baseline at 6 weeks
serum iron
Time frame: change from baseline at 6 weeks
hs-CRP
Time frame: change from baseline at 6 weeks
pulse rate
Time frame: change from baseline at 6 weeks
serum glucose
Time frame: change from baseline at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
- Derived from this study: PubMed 22647517Houschyar 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.
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Michalsen, Prof., M.D. principal investigator
Charite-University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing blood letting in people with Metabolic Syndrome, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insulin sensitivity (time frame: change from baseline at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01328210, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2011.