The Focus of Study is to Determine the Waist Circumference Values to Predict Overweight or ObesityNCT01914640
The Sex Specific Waist Circumference Cut Off Points to Predict Overweight or Obesity
An observational study of The Focus of Study is to Determine the Waist Circumference Values to Predict Overweight or Obesity, run by TC Erciyes University.
Trial summary
The waist circumference (WC) cut off levels of the Caucasian people may not represent the characteristics of different ethnic groups. The investigators aimed to determine sex specific WC cut off points to predict obesity, metabolic syndrome and increased cardiovascular risk in Turkish adults. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- The Focus of Study is to Determine the Waist Circumference Values to Predict Overweight or Obesity
- How many people
- 4,310 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Sep 2005
- 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 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This cross-sectional study was conducted in 24 provinces from the 7 regions of Turkey. Turkish adult males and non-pregnant females were randomly enrolled from both the provincial district centers and villages, considering the demographics, economic, social, and geographical statuses.
Who may be able to join
- Adult Male or nonpregnant Female
Who cannot join
- Pregnant females, Subjects younger than 20 or older than 83
About this study
Official title: The Cross Sectional Study to Investigate the Waist Circumference Cut Off Points for the Prediction of Overweight and Obesity of the Turkish Adult Population
The waist circumference (WC) cut off levels of the Caucasian people may not represent the characteristics of different ethnic groups. The investigators aimed to determine sex specific WC cut off points to predict obesity, metabolic syndrome and increased cardiovascular risk in Turkish adults.
Read the detailed description
Waist circumference (WC) is an easy and reliable measure of visceral adipose tissue and a simple index of cardiovascular risk. The World Health Organization (WHO) reported sex specific WC cut off values for the Caucasian people, named as action levels 1 and 2, to define the overweight or obese people. These cut off values, originally established in a Dutch population, were later adopted by several medical organizations in order to define Metabolic Syndrome. However, these cut off levels may not necessarily represent the characteristics of the other populations. Therefore it is recommended that the sex specific WC cut off points should be established for different ethnic groups.
The investigators aimed to investigate whether the suggested sex specific WC cut off points for the Caucasian adults are appropriate for the Turkish adult population. The secondary aim of the study is to search for better WC cut off points to predict obesity, metabolic syndrome and increased cardiovascular risk in Turkish adult men and women.
- Conditions
- The Focus of Study is to Determine the Waist Circumference Values to Predict Overweight or Obesity
- Keywords
- Waist circumference, Metabolic Syndrome, Cardiovascular risk
- Medical subject headings
- Obesity, Metabolic Syndrome
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 |
|---|---|---|
| Healthy adults living in Turkey | The group was enrolled from the 24 provinces of the 7 regions of Turkey. At least 3 provinces were selected from each region by a random sampling method. The populations of these 7 regions were obtained from the records of the 2000 census. The study sample included males and non-pregnant females aged between 20 and 83 years. The populations of city centers, districts, and villages were classified by using the stratified sampling method and then were selected from the data collected from the household identification forms by random sampling. The geography of Turkey was classified into three groups according to altitude. Sea level was accepted as zero. 0-300 m was taken as coastal, 300-900 m as moderate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist circumference cut off levels
These cut off levels were determined by the receiver operating curve analyses. The sum of the highest sensitivity and specificity values of the WC levels to determine the overweight (Body mass index (BMI) > 25kg/m2) and obese (BMI>30kg/m2) adults were taken as the cut off points. The cut off points to determine the overweight, were also taken as the WC limits for the diagnosis of metabolic syndrome.
Measured: About a year to collect all the demographic data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startMar 2003
- Primary completionSep 2004
- Study completionSep 2005
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 The Focus of Study is to Determine the Waist Circumference Values to Predict Overweight or ObesityStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 4,310 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahri Bayram, TC Erciyes University
- Investigators
- Fahri Bayram, MD. Prof., Study director, Head of the Study Group of Hypertension, Lipid disorders and Obesity of Turkish Society of Endocrinology and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914640
- Sponsor's protocol ID
- TEMD/OBDLHT- 0001
- Status last verified
- Jul 2013
- First submitted
- 25 Jul 2013
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gundogan K, Bayram F, Gedik V, Kaya A, Karaman A, Demir O, Sabuncu T, Kocer D, Coskun R. Metabolic syndrome prevalence according to ATP III and IDF criteria and related factors in Turkish adults. Arch Med Sci. 2013 Apr 20;9(2):243-53. doi: 10.5114/aoms.2013.34560. Epub 2013 Apr 12.
PubMed 23671434
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cross Sectional Study to Investigate the Waist Circumference Cut Off Points for the Prediction of Overweight and Obesity of the Turkish Adult Population
- ClinicalTrials.gov ID
- NCT01914640
- Acronym / sponsor ID
- TEMD/OBDLHT- 0001
- Conditions
- The Focus of Study is to Determine the Waist Circumference Values to Predict Overweight or Obesity
- Keywords
- Waist circumference, Metabolic Syndrome, Cardiovascular risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,310 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 2 Aug 2013 (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 waist circumference (WC) cut off levels of the Caucasian people may not represent the characteristics of different ethnic groups. The investigators aimed to determine sex specific WC cut off points to predict obesity, metabolic syndrome and increased cardiovascular risk in Turkish adults.
Detailed description
Waist circumference (WC) is an easy and reliable measure of visceral adipose tissue and a simple index of cardiovascular risk. The World Health Organization (WHO) reported sex specific WC cut off values for the Caucasian people, named as action levels 1 and 2, to define the overweight or obese people. These cut off values, originally established in a Dutch population, were later adopted by several medical organizations in order to define Metabolic Syndrome. However, these cut off levels may not necessarily represent the characteristics of the other populations. Therefore it is recommended that the sex specific WC cut off points should be established for different ethnic groups.
The investigators aimed to investigate whether the suggested sex specific WC cut off points for the Caucasian adults are appropriate for the Turkish adult population. The secondary aim of the study is to search for better WC cut off points to predict obesity, metabolic syndrome and increased cardiovascular risk in Turkish adult men and women.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults living in Turkey | – | –The group was enrolled from the 24 provinces of the 7 regions of Turkey. At least 3 provinces were selected from each region by a random sampling method. The populations of these 7 regions were obtained from the records of the 2000 census. The study sample included males and non-pregnant females aged between 20 and 83 years. The populations of city centers, districts, and villages were classified by using the stratified sampling method and then were selected from the data collected from the household identification forms by random sampling. The geography of Turkey was classified into three groups according to altitude. Sea level was accepted as zero. 0-300 m was taken as coastal, 300-900 m as moderate |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This cross-sectional study was conducted in 24 provinces from the 7 regions of Turkey. Turkish adult males and non-pregnant females were randomly enrolled from both the provincial district centers and villages, considering the demographics, economic, social, and geographical statuses.
Key inclusion criteria (1 listed)
- Adult Male or nonpregnant Female
Key exclusion criteria (1 listed)
- Pregnant females, Subjects younger than 20 or older than 83
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
Waist circumference cut off levels
Time frame: About a year to collect all the demographic data
These cut off levels were determined by the receiver operating curve analyses. The sum of the highest sensitivity and specificity values of the WC levels to determine the overweight (Body mass index (BMI) > 25kg/m2) and obese (BMI>30kg/m2) adults were taken as the cut off points. The cut off points to determine the overweight, were also taken as the WC limits for the diagnosis of metabolic syndrome.
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 2 Aug 2013.
- Background: PubMed 23671434Gundogan K, Bayram F, Gedik V, Kaya A, Karaman A, Demir O, Sabuncu T, Kocer D, Coskun R. Metabolic syndrome prevalence according to ATP III and IDF criteria and related factors in Turkish adults. Arch Med Sci. 2013 Apr 20;9(2):243-53. doi: 10.5114/aoms.2013.34560. Epub 2013 Apr 12.
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.
Fahri Bayram, MD. Prof. study director
Head of the Study Group of Hypertension, Lipid disorders and Obesity of Turkish Society of Endocrinology and Metabolism
Questions about this trial
What is this clinical trial studying?
An observational study of The Focus of Study is to Determine the Waist Circumference Values to Predict Overweight or Obesity, run by TC Erciyes University.
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 1 inclusion and 1 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 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Waist circumference cut off levels (time frame: About a year to collect all the demographic data). 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 NCT01914640, 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 2 Aug 2013.