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NCT02093858 Clinical Trial

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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02093858
Other study ID # RRW
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 20, 2014
Last updated March 20, 2014
Start date April 2014
Est. completion date December 2017

Study information
Verified date March 2014
Source Central South University
Contact RenRong Wu, PhD
Phone 0731-85554052
Email wurenrong2013@163.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical 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 TCF7L2 and SLC30A8 play an important part in the development of antipsychotics-induced metabolic syndrome.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 212
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 45 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
China Mental Health Institute Changsha Hunan

Sponsors (1)
Lead Sponsor Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Other Change of serum insulin 24 weeks No
Primary Change in weight and blood glucose 24 weeks Yes
Secondary Change of the blood pressure and blood lipid 24 weeks Yes
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