Glucose as a Mediator of Self-control Performances in Pat... | NCT01563016

Studies
Glucose as a Mediator of Self-control Performances in Patients With Schizophrenia

NCT01563016

Sponsor

The University of Hong Kong

Status

Unknown status

Last Update Posted

Mar 26, 2012Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Schizophrenia

Interventions

glucose drink

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 2012

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 2012

Primary Completion Date

Apr 2013Estimated

Completion Date

Apr 2013Estimated

First Submitted Date

Mar 22, 2012

First Submission Date that Met QC Criteria

Mar 23, 2012

First Posted Date

Mar 26, 2012Estimated

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 23, 2012

Last Update Posted Date

Mar 26, 2012Estimated

Name	Class
Queen Mary Hospital, Hong Kong	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

The research aims to investigate the relationship between self-control ability and blood glucose level in schizophrenic patients. The main purpose of the present study is to explore whether the close relationship of blood glucose and self-regulatory strength observed in healthy individuals, is applicable to schizophrenic patients. More specifically, the current study aims

to investigate whether the exertion of self-control reduces blood glucose,
to examine whether low level of blood glucose deteriorates subsequent self-control performances
to examine whether restoring the glucose level eliminates these impairments, in schizophrenic patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glucose & Depleting	Experimental	participants will perform in a depleting task and receive a glucose drink	Dietary Supplement: glucose drink
Glucose & non-depleting	Placebo Comparator	participants will perform in a non-depleting task and receive a glucose drink	Dietary Supplement: glucose drink
Placebo & depleting	No Intervention	participants will perform in a depleting task and receive a placebo drink
Placebo & non depleting	No Intervention	participants will perform in a non depleting task and receive a placebo drink

Interventions

Name	Type	Description	Arm Group Labels	Other Names
glucose drink	Dietary Supplement	participants will receive a drink rich in glucose	Glucose & Depleting Glucose & non-depleting

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Glucose Level		baseline, after depleting task
self control tasks (handgrip, stroop, figure tracing task)		after 12-minutes metabolizing phase

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 15 or above
DSM-IV diagnosis of schizophrenia, schizoaffective disorder, schizophreniform psychosis, brief psychosis, psychosis NOS or delusional disorder
Cantonese-speaking Chinese
Ability to understand the nature of the study and sign informed consent

Exclusion Criteria:

Organic Brain disorder
Known history of intellectual disability
Priority Follow Up (Subtarget or Target)
All allergic to any sugar or artificial sweeteners
Diabetics
Physical Disability

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eric YH Chen, MD	Contact	852-22553063		eyhchen@hku.hk
Chung-Ming Leung, Bsc	Contact	852-64054460		mingming4f29@hotmail.com

Overall Officials

Name	Affiliation	Role
Eric YH Chen, MD	The University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Hong Kong		Hong Kong			China

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D011618	Psychotic Disorders

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided