The Mechanism of TCF7L2 and SLC30A8 on Antipsychotic-induced Metabolic Syndrome

March 20, 2014 updated by: Renrong Wu, Central South University
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

212

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • Mental Health Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Clinical diagnosis of first episode schizophrenia
  • Must be able to swallow tablets
  • Take only one antipsychotics

Exclusion Criteria:

  • liver or renal or cardiovascular diseases
  • pregnant or lactating women
  • drug and alcohol dependence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
olanzapine
15-25mg/day for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in weight and blood glucose
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of the blood pressure and blood lipid
Time Frame: 24 weeks
24 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Change of serum insulin
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central South University

Investigators

  • Principal Investigator: Wu R Rong, PhD, Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

March 20, 2014

First Submitted That Met QC Criteria

March 20, 2014

First Posted (Estimate)

March 21, 2014

Study Record Updates

Last Update Posted (Estimate)

March 21, 2014

Last Update Submitted That Met QC Criteria

March 20, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRW

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe