Metabolic Syndrome XHERMETNCT00515476
Effect of Exercise Training on the Function of the High Density Lipoprotein (HDL)-Cholesterol, Endothelial Function and Endothelial Progenitor Cells in Patients With Metabolic Syndrome(HERMET-Study)
A study testing physical exercise in people with Metabolic Syndrome X, run by Hannover Medical School at 1 site in Germany.
Trial summary
The purpose of the present study is to characterize the quality of HDL-Cholesterol in patients with metabolic syndrome and reduced blood HDL-Cholesterol levels and to examine the effect of exercise training on the vasculoprotective effects of HDL-Cholesterol in these patients. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- physical exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2007to Dec 2008
- Phase
- Interventional
- 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Reduced HDL-Cholesterol levels in blood: < 40 mg/dl (1.03 mmol/L) in male, < 50 mg/dl (1.29 mmol/L) in female
- Plus two of the following criteria:
- Elevated waist circumference: ≥ 102 cm (≥ 40 inches) in men or ≥ 88 cm (≥ 35 inches) in women
- Elevated triglycerides: ≥ 150 mg/dL (1.7 mmol/L
- Elevated blood pressure: ≥ 130 mmHg systolic blood pressure or ≥ 80 mmHg
- diastolic blood pressure or anti-hypertensive treatment
- Elevated fasting glucose: ≥ 100 mg/dL or on drug treatment for elevated fasting glucose
Who cannot join
- Acute coronary syndrome
- Unstable Angina pectoris
- Myocardial infarction during the last 8 weeks
- Therapy with Niacin
- Active infections
- Ventricular arrhythmias
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- Systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg
- Cancer
- Pregnancy, lactation
- Alcoholism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Clinical Trial to Study the Effect of Exercise Training on the Function of HDL-Cholesterol, Endothelial Function, Oxidative Stress and Regenerative Capacity of Endothelial Progenitor Cells in Patients With Metabolic Syndrome
The purpose of the present study is to characterize the quality of HDL-Cholesterol in patients with metabolic syndrome and reduced blood HDL-Cholesterol levels and to examine the effect of exercise training on the vasculoprotective effects of HDL-Cholesterol in these patients. Additionally the investigators aim to investigate the endothelial function, oxidative stress and the regenerative capacity of the endothelial progenitor cells in patients with metabolic syndrome and the changes dependent on physical activity of patients.
- Conditions
- Metabolic Syndrome X
- Being tested
- physical exercise
- Keywords
- metabolic syndrome, HDL-Cholesterol, EPC, endothelial function, reduced blood HDL-Cholesterol level
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exerciseBehavioural
8 weeks of regular exercise training
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary: vasculoprotective and regenerative functions of HDL-Cholesterol and EPC function before and after 8-weeks exercise training
Measured: before and after 8-weeks exercise training
Secondary outcomes (1)
Secondary: flow-mediated, endothelium-dependent vasodilation of radial artery measured by ultrasound
Measured: before and 8 weeks after exercise training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2007 (estimated)
- Study startJun 2007
- Primary completionNov 2008
- Study completionDec 2008
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 Syndrome XStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Investigators
- Helmut Drexler, MD, Study director, Hannover Medical SchoolKristina Sonnenschein, MD, Principal investigator, Hannover Medical SchoolUlf Landmesser, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515476
- Sponsor's protocol ID
- 4031215
- Acronym
- HERMET
- Status last verified
- Nov 2009
- First submitted
- 9 Aug 2007
- Last updated
- 23 Jun 2010
- Results posted
- No
Publications
Sonnenschein K, Horvath T, Mueller M, Markowski A, Siegmund T, Jacob C, Drexler H, Landmesser U. Exercise training improves in vivo endothelial repair capacity of early endothelial progenitor cells in subjects with metabolic syndrome. Eur J Cardiovasc Prev Rehabil. 2011 Jun;18(3):406-14. doi: 10.1177/1741826710389373. Epub 2011 Feb 11.
PubMed 21450652
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Clinical Trial to Study the Effect of Exercise Training on the Function of HDL-Cholesterol, Endothelial Function, Oxidative Stress and Regenerative Capacity of Endothelial Progenitor Cells in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00515476
- Acronym / sponsor ID
- HERMET / 4031215
- Conditions
- Metabolic Syndrome X
- Keywords
- metabolic syndrome, HDL-Cholesterol, EPC, endothelial function, reduced blood HDL-Cholesterol level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 13 Aug 2007 (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.
The purpose of the present study is to characterize the quality of HDL-Cholesterol in patients with metabolic syndrome and reduced blood HDL-Cholesterol levels and to examine the effect of exercise training on the vasculoprotective effects of HDL-Cholesterol in these patients. Additionally the investigators aim to investigate the endothelial function, oxidative stress and the regenerative capacity of the endothelial progenitor cells in patients with metabolic syndrome and the changes dependent on physical activity of patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Reduced HDL-Cholesterol levels in blood: < 40 mg/dl (1.03 mmol/L) in male, < 50 mg/dl (1.29 mmol/L) in female
- Plus two of the following criteria:
- Elevated waist circumference: ≥ 102 cm (≥ 40 inches) in men or ≥ 88 cm (≥ 35 inches) in women
- Elevated triglycerides: ≥ 150 mg/dL (1.7 mmol/L
- Elevated blood pressure: ≥ 130 mmHg systolic blood pressure or ≥ 80 mmHg
Key exclusion criteria (10 listed)
- Acute coronary syndrome
- Unstable Angina pectoris
- Myocardial infarction during the last 8 weeks
- Therapy with Niacin
- Active infections
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 |
|---|---|---|
| physical exercise8 weeks of regular exercise training | Behavioural | – |
Primary outcome
Primary: vasculoprotective and regenerative functions of HDL-Cholesterol and EPC function before and after 8-weeks exercise training
Time frame: before and after 8-weeks exercise training
1 secondary outcome
Secondary: flow-mediated, endothelium-dependent vasodilation of radial artery measured by ultrasound
Time frame: before and 8 weeks after exercise training
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 23 Jun 2010.
- Derived from this study: PubMed 21450652Sonnenschein K, Horvath T, Mueller M, Markowski A, Siegmund T, Jacob C, Drexler H, Landmesser U. Exercise training improves in vivo endothelial repair capacity of early endothelial progenitor cells in subjects with metabolic syndrome. Eur J Cardiovasc Prev Rehabil. 2011 Jun;18(3):406-14. doi: 10.1177/1741826710389373. Epub 2011 Feb 11.
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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.
Helmut Drexler, MD study director
Hannover Medical School
Kristina Sonnenschein, MD principal investigator
Hannover Medical School
Ulf Landmesser, MD principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical exercise in people with Metabolic Syndrome X, run by Hannover Medical School 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 7 inclusion and 10 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 23 Jun 2010. 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.
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?
Primary: vasculoprotective and regenerative functions of HDL-Cholesterol and EPC function before and after 8-weeks exercise training (time frame: before and after 8-weeks exercise training). 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 NCT00515476, 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 23 Jun 2010.