Waist Circumference MeasurementsNCT01243034
Waist Circumference Measurements in Schizophrenic Patients
An observational study of Waist Circumference Measurements and Schizophrenia, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
The prevalence of metabolic syndrome(MS) among pt's with schizophrenia has been reported to be high, ranging from 24 to 43% in males and 27 to 52% in females. Schizophrenic patients with MS have an increased incidence of DM, coronary heart disease and increased mortality from cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Waist Circumference Measurements, Schizophrenia, Cardiovascular Risk Factor
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2010to 31 Jul 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: schizophrenia outpatients
Who may be able to join
- • Patients with schizophrenia or schizoaffective disorder (DSM-IV 295) age 18 till 65 years old.
- Body weight change less than 1 kg in previous one month before index date.
Who cannot join
- • Patients with a previous hyperlipidemia diagnosis or antilipemic prescription during the preceding 30 days.
- Patients received any anti-hypertensives or oral hypoglycemic agents.
- Pregnant or breast-feeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Variability of Waist Circumference Measurements at 3 Sites and Its Relationship With Cardiovascular Risk Factors in Patients With Schizophrenia
The prevalence of metabolic syndrome(MS) among pt's with schizophrenia has been reported to be high, ranging from 24 to 43% in males and 27 to 52% in females. Schizophrenic patients with MS have an increased incidence of DM, coronary heart disease and increased mortality from cardiovascular diseases. Central adiposity is highly correlated with the presence of hypertension, coronary heart disease, type 2 diabetes, and increased mortality risk. Waist circumference(WC) is a better indicator of abdominal obesity and a better predictor of CVD than either BMI or waist-to-hip ratio. However, currently there is no standard location for the measurement of WC.
Objectives: 1. To compare the magnitude of WC measured at 3 sites ( immediately above the iliac crest, midpoint between the lowest rib and the iliac crest , umbilical level) in males and females.
- To examine the correlation of WC with Triglyceride, cholesterol, HDL, LDL and glucose.
- Medical subject headings
- Schizophrenia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study start1 Aug 2010
- Primary completion31 Jul 2011
- Study completion31 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waist Circumference MeasurementsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng-Chen Chang, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243034
- Sponsor's protocol ID
- 100717
- Status last verified
- Jan 2019
- First submitted
- 17 Nov 2010
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variability of Waist Circumference Measurements at 3 Sites and Its Relationship With Cardiovascular Risk Factors in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01243034
- Acronym / sponsor ID
- 100717
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 1 Aug 2010 (actual)
- Primary completion
- 31 Jul 2011 (actual)
- Study completion
- 31 Jul 2011 (actual)
- First posted
- 18 Nov 2010 (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 prevalence of metabolic syndrome(MS) among pt's with schizophrenia has been reported to be high, ranging from 24 to 43% in males and 27 to 52% in females. Schizophrenic patients with MS have an increased incidence of DM, coronary heart disease and increased mortality from cardiovascular diseases. Central adiposity is highly correlated with the presence of hypertension, coronary heart disease, type 2 diabetes, and increased mortality risk. Waist circumference(WC) is a better indicator of abdominal obesity and a better predictor of CVD than either BMI or waist-to-hip ratio. However, currently there is no standard location for the measurement of WC.
Objectives: 1. To compare the magnitude of WC measured at 3 sites ( immediately above the iliac crest, midpoint between the lowest rib and the iliac crest , umbilical level) in males and females.
- To examine the correlation of WC with Triglyceride, cholesterol, HDL, LDL and glucose.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- schizophrenia outpatients
Key inclusion criteria (2 listed)
- • Patients with schizophrenia or schizoaffective disorder (DSM-IV 295) age 18 till 65 years old.
Key exclusion criteria (3 listed)
- • Patients with a previous hyperlipidemia diagnosis or antilipemic prescription during the preceding 30 days.
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
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 1 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Waist Circumference Measurements and Schizophrenia, run by Changhua Christian Hospital at 1 site in Taiwan.
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 3 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 1 Feb 2019. 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 Taiwan. 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.
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 1 Feb 2019.