The Mechanism of TCF7L2 and SLC30A8 on Antipsychotic-indu... | NCT02093858

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

NCT02093858

Sponsor

Central South University

Status

Unknown status

Last Update Posted

Mar 21, 2014Estimated

Enrollment

212Estimated

Phase

Not provided

Conditions

Schizophrenia
Metabolic Syndrome

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Mar 20, 2014

First Submission Date that Met QC Criteria

Mar 20, 2014

First Posted Date

Mar 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2014

Last Update Posted Date

Mar 21, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

212Estimated

Label	Type	Description	Intervention Names
olanzapine		15-25mg/day for 24 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in weight and blood glucose		24 weeks

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Change of serum insulin		24 weeks

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
RenRong Wu, PhD	Contact	0731-85554052		wurenrong2013@163.com

Overall Officials

Name	Affiliation	Role
Wu R Rong, PhD	Central South University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mental Health Institute		Changsha	Hunan	410011	China

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D007333	Insulin Resistance
D006946	Hyperinsulinism

Browse Leaves

Not provided

Browse Branches

Not provided