SchizophreniaNCT02093858
The Mechanism of TCF7L2 and SLC30A8 on Antipsychotic-induced Metabolic Syndrome
An observational study of Schizophrenia and Metabolic Syndrome, run by Central South University at 1 site in China.
Trial summary
Almost all of antipsychotics can induce metabolic syndrome,Genetic factors play a key role in the development of metabolic syndrome,TCF7L2 and SLC30A8 are strongestly correlated with metabolic syndrome.Moreover,Antipsychotics have an effect on the expression of TCF7L2 and SLC30A8 genes.It indicates the variations of… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia, Metabolic Syndrome
- How many people
- 212 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Dec 2017
- 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
- All sexes
- No healthy volunteers
- Adult
Study population: All participants met the Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-IV) criteria for first episode schizophrenia.All of the patients and their familier are know of the study and sign the informed consent.
Who may be able to join
- Clinical diagnosis of first episode schizophrenia
- Must be able to swallow tablets
- Take only one antipsychotics
Who cannot join
- liver or renal or cardiovascular diseases
- pregnant or lactating women
- drug and alcohol dependence
Trial locations and contacts
1 site in 1 country.
China1 site
Mental Health Institute
Changsha, Hunan, 410011
Renrong Wu, PhD, 86-15874179855, wurenrong2013@163.com.cn
Renrong Wu, Doctor
About this study
Almost all of antipsychotics can induce metabolic syndrome,Genetic factors play a key role in the development of metabolic syndrome,TCF7L2 and SLC30A8 are strongestly correlated with metabolic syndrome.Moreover,Antipsychotics have an effect on the expression of TCF7L2 and SLC30A8 genes.It indicates the variations of TCF7L2 and SLC30A8 play an important part in the development of antipsychotics-induced metabolic syndrome.
Read the detailed description
- In this study, we will determine the effect of olanzapine on the expression of TCF7L2 and SLC30A8.
- The relationship of the polymorphism of TCF7L2 and SLC30A8 with antipsychotic-induced metabolic syndrome in schizophrenia patients.
- Conditions
- Schizophrenia, Metabolic Syndrome
- Keywords
- Metabolic Syndrome
- Medical subject headings
- Schizophrenia, 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 |
|---|---|---|
| olanzapine | 15-25mg/day for 24 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight and blood glucose
Measured: 24 weeks
Secondary outcomes (1)
Change of the blood pressure and blood lipid
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renrong Wu, Central South University
- Investigators
- Wu R Rong, PhD, Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093858
- Sponsor's protocol ID
- RRW
- Status last verified
- Mar 2014
- First submitted
- 20 Mar 2014
- Last updated
- 21 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanism of TCF7L2 and SLC30A8 on Antipsychotic-induced Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02093858
- Acronym / sponsor ID
- RRW
- Conditions
- Schizophrenia, Metabolic Syndrome
- Keywords
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 21 Mar 2014 (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.
Almost all of antipsychotics can induce metabolic syndrome,Genetic factors play a key role in the development of metabolic syndrome,TCF7L2 and SLC30A8 are strongestly correlated with metabolic syndrome.Moreover,Antipsychotics have an effect on the expression of TCF7L2 and SLC30A8 genes.It indicates the variations of TCF7L2 and SLC30A8 play an important part in the development of antipsychotics-induced metabolic syndrome.
Detailed description
- In this study, we will determine the effect of olanzapine on the expression of TCF7L2 and SLC30A8.
- The relationship of the polymorphism of TCF7L2 and SLC30A8 with antipsychotic-induced metabolic syndrome in schizophrenia patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| olanzapine | – | –15-25mg/day for 24 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All participants met the Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-IV) criteria for first episode schizophrenia.All of the patients and their familier are know of the study and sign the informed consent.
Key inclusion criteria (3 listed)
- Clinical diagnosis of first episode schizophrenia
- Must be able to swallow tablets
- Take only one antipsychotics
Key exclusion criteria (3 listed)
- liver or renal or cardiovascular diseases
- pregnant or lactating women
- drug and alcohol dependence
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
Change in weight and blood glucose
Time frame: 24 weeks
1 secondary outcome
Change of the blood pressure and blood lipid
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2014.
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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.
Wu R Rong, PhD principal investigator
Central South University
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 Schizophrenia and Metabolic Syndrome, run by Central South University at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 21 Mar 2014. 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 China. 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?
Contact RenRong Wu, PhD (0731-85554052, wurenrong2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight and blood glucose (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
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 21 Mar 2014.