Metabolic SyndromeNCT01586754
Subclinical Organ Damage in Overweight and Obese Patients: Does Presence of Metabolic Syndrome Matter?
An observational study of Metabolic Syndrome and Subclinical Organ Damage, run by Goztepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Microalbuminuria and homocysteine levels are shown to be markers for endothelial dysfunction and subclinical organ damage and predictors of cardiovascular risk in several epidemiologic and randomized clinical trials. Carotis intima-media thickness is also found to be elevated in early stages of atherosclerosis. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Subclinical Organ Damage, Overweight
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2011to May 2012
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Obese or overweight patients, aged between 18-80 who are non-smokers, with a GFR > 60 ml/min and without any history of diabetes (insulin dependent or non-insulin dependent), coronary artery disease or peripheral arterial disease, attending to hyperlipidemia and obesity outpatient clinic.
Who may be able to join
- 18-80 years
- BMI >= 25
- Ex or non-smokers (must have quit smoking at least 5 years ago)
Who cannot join
- NIDDM or IDDDM
- Nephropathy (GFR < 60 ml/min), previous history of coronary artery disease or peripheral arterial disease
- Current smokers
- Active infection or other acute illness
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University Goztepe Training and Research Hospital
Istanbul, 34000
About this study
Microalbuminuria and homocysteine levels are shown to be markers for endothelial dysfunction and subclinical organ damage and predictors of cardiovascular risk in several epidemiologic and randomized clinical trials. Carotis intima-media thickness is also found to be elevated in early stages of atherosclerosis. Recent studies have shown correlations between homocysteine, microalbumin levels and carotis intima-media thickness in type 2 diabetics but no data exists for obese or overweight patients who also have metabolic syndrome, in terms of markers of subclinical organ damage. Since obesity is a risk factor for cardiovascular disease and since it is known that patients with metabolic syndrome are at higher risk of cardiovascular events, the investigators wanted to examine whether there is an association between homocysteine, microalbumin levels and carotid intima-media thickness in patients with or without metabolic syndrome, who are either overweight or obese.
- Conditions
- Metabolic Syndrome, Subclinical Organ Damage, Overweight, Obese
- Keywords
- metabolic syndrome, obesity, endothelial damage, homocysteine, microalbumin, carotis intima-media thickness
- Medical subject headings
- Metabolic Syndrome, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| With Metabolic Syndrome | Not described | |
| Without Metabolic Syndrome | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startOct 2011
- Primary completionApr 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goztepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Ekiz, Goztepe Training and Research Hospital
- Investigators
- ESRA EKIZ, MD, Principal investigator, Istanbul Medeniyet University Goztepe Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586754
- Sponsor's protocol ID
- 34
- Status last verified
- Apr 2012
- First submitted
- 25 Apr 2012
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subclinical Organ Damage in Overweight and Obese Patients: Does Presence of Metabolic Syndrome Matter?
- ClinicalTrials.gov ID
- NCT01586754
- Acronym / sponsor ID
- 34
- Conditions
- Metabolic Syndrome, Subclinical Organ Damage, Overweight, Obese
- Keywords
- metabolic syndrome, obesity, endothelial damage, homocysteine, microalbumin, carotis intima-media thickness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Goztepe Training and Research HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 27 Apr 2012 (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.
Microalbuminuria and homocysteine levels are shown to be markers for endothelial dysfunction and subclinical organ damage and predictors of cardiovascular risk in several epidemiologic and randomized clinical trials. Carotis intima-media thickness is also found to be elevated in early stages of atherosclerosis. Recent studies have shown correlations between homocysteine, microalbumin levels and carotis intima-media thickness in type 2 diabetics but no data exists for obese or overweight patients who also have metabolic syndrome, in terms of markers of subclinical organ damage. Since obesity is a risk factor for cardiovascular disease and since it is known that patients with metabolic syndrome are at higher risk of cardiovascular events, the investigators wanted to examine whether there is an association between homocysteine, microalbumin levels and carotid intima-media thickness in patients with or without metabolic syndrome, who are either overweight or obese.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Metabolic Syndrome | – | – |
| Without Metabolic Syndrome | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obese or overweight patients, aged between 18-80 who are non-smokers, with a GFR > 60 ml/min and without any history of diabetes (insulin dependent or non-insulin dependent), coronary artery disease or peripheral arterial disease, attending to hyperlipidemia and obesity outpatient clinic.
Key inclusion criteria (3 listed)
- 18-80 years
- BMI >= 25
- Ex or non-smokers (must have quit smoking at least 5 years ago)
Key exclusion criteria (4 listed)
- NIDDM or IDDDM
- Nephropathy (GFR < 60 ml/min), previous history of coronary artery disease or peripheral arterial disease
- Current smokers
- Active infection or other acute illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.
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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.
ESRA EKIZ, MD principal investigator
Istanbul Medeniyet University Goztepe Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Subclinical Organ Damage, run by Goztepe Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Apr 2012. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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.
Where can I read the original study information?
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 27 Apr 2012.