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Status unknownNCT01586754Updated Apr 27, 2012

Subclinical Organ Damage in Overweight and Obese Patients: Does Presence of Metabolic Syndrome Matter?

An observational study in Metabolic Syndrome, Subclinical Organ Damage and Overweight, sponsored by Goztepe Training and Research Hospital. Status unknown at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-04-27.

Sponsored by Goztepe Training and Research Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 80 Years
Sex
All
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Study 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. 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.

02

Conditions studied

  • Metabolic Syndrome
  • Subclinical Organ Damage
  • Overweight
  • Obese

Keywords

  • metabolic syndrome
  • obesity
  • endothelial damage
  • homocysteine
  • microalbumin
  • carotis intima-media thickness
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In context

Metabolic Syndrome

2,011 studies on the registry are indexed under Metabolic Syndrome; 334 are open to participants now.

This study's enrollment of 100 is below the median of 200 across 469 observational studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Goztepe Training and Research Hospital is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 18-80 years
  2. BMI >= 25
  3. Ex or non-smokers (must have quit smoking at least 5 years ago)

Exclusion criteria

Exclusion Criteria:

  1. NIDDM or IDDDM
  2. Nephropathy (GFR \< 60 ml/min), previous history of coronary artery disease or peripheral arterial disease
  3. Current smokers
  4. Active infection or other acute illness
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
100 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • With Metabolic Syndrome
  • Without Metabolic Syndrome
06

Study locations

1 site
  • Istanbul Medeniyet University Goztepe Training and Research Hospital
    Istanbul, 34000, Turkey (Türkiye)
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2011, a primary completion of Apr 2012 and a completion of May 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 25, 2012
First posted
Apr 27, 2012
Start
Oct 2011
Primary completionEst.
Apr 2012
CompletionEst.
May 2012
Last update
Apr 27, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01586754
Lead sponsor
Goztepe Training and Research Hospital
Responsible party
Esra Ekiz (Medical Doctor/Resident, Goztepe Training and Research Hospital) — Principal investigator
First posted
Apr 27, 2012
Start date
Oct 2011
Primary completion
Apr 2012 (estimated)
Completion
May 2012 (estimated)
Last update
Apr 27, 2012

Study contacts

ESRA EKIZ, MD
principal investigator · Istanbul Medeniyet University Goztepe Training and Research Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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