Metabolic SyndromeNCT00636753
Antipsychotics and Metabolic Syndrome
An observational study of Metabolic Syndrome, run by Glostrup University Hospital, Copenhagen at 2 sites in Denmark.
Trial summary
The purpose of the study is to determine whether antipsychotic treatment is influence psychiatric patients due to endocrine and metabolic status and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Metabolic Syndrome
- How many people
- 60 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2008to Jul 2009
- 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 45 years
- Men only
- No healthy volunteers
- Adult
Study population: patients with debut of schizophrenia, controls from database
Who may be able to join
- Gender male
- Age 18-45
- Debut drug-naive schizophrenics,
- Caucasians
- Consent given to take part in the project
Who cannot join
- Compliance-problems
- Major lung-/kidney/hart/lever disorders
- Abuse of alcohol/drugs
- Diabetes 1 and 2
- Antihypertensive
- Anticholesterol-reducing medication
- Patients under duress
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Psychiatric Center Glostrup
Copenhagen, Nordre Ringvej 28-69, Glostrup, 2600
Psychiatric Center Glostrup
Nordre Ringvej 28-69, Glostrup, 2600
About this study
The purpose of the study is to determine whether antipsychotic treatment is influence psychiatric patients due to endocrine and metabolic status and quality of life.
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic and endocrine changes in schizophrenic patients by antipsychotics treatment.
- Medical subject headings
- 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 |
|---|---|---|
| 1 | schizophrenic patients | |
| 2 | controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2009 (estimated)
Why it stopped: this study has not finding place
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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636753
- Sponsor's protocol ID
- HC-2007-0070
- Status last verified
- Jul 2010
- First submitted
- 7 Mar 2008
- Last updated
- 30 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antipsychotics and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00636753
- Acronym / sponsor ID
- HC-2007-0070
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic and endocrine changes in schizophrenic patients by antipsychotics treatment.
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: this study has not finding place
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jul 2009 (estimated)
- First posted
- 14 Mar 2008 (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 study is to determine whether antipsychotic treatment is influence psychiatric patients due to endocrine and metabolic status and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –schizophrenic patients |
| 2 | – | –controls |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients with debut of schizophrenia, controls from database
Key inclusion criteria (5 listed)
- Gender male
- Age 18-45
- Debut drug-naive schizophrenics,
- Caucasians
- Consent given to take part in the project
Key exclusion criteria (7 listed)
- Compliance-problems
- Major lung-/kidney/hart/lever disorders
- Abuse of alcohol/drugs
- Diabetes 1 and 2
- Antihypertensive
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 30 Jul 2010.
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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.
2 sites 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, run by Glostrup University Hospital, Copenhagen at 2 sites in Denmark.
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 5 inclusion and 7 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: paused, as of the sponsor's last update on 30 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 30 Jul 2010.