- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01563016
Glucose as a Mediator of Self-control Performances in Patients With Schizophrenia
March 23, 2012 updated by: The University of Hong Kong
Glucose as a Mediator of Self-control Performances in Patients With Schizophrenia: A Randomized Controlled Study
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eric YH Chen, MD
- Phone Number: 852-22553063
- Email: eyhchen@hku.hk
Study Contact Backup
- Name: Chung-Ming Leung, Bsc
- Phone Number: 852-64054460
- Email: mingming4f29@hotmail.com
Study Locations
-
-
-
Hong Kong, China
- The University of Hong Kong
-
Contact:
- Bonnie Choi
- Email: bwschoi@hku.hk
-
-
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
15 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Glucose & Depleting
participants will perform in a depleting task and receive a glucose drink
|
participants will receive a drink rich in glucose
|
PLACEBO_COMPARATOR: Glucose & non-depleting
participants will perform in a non-depleting task and receive a glucose drink
|
participants will receive a drink rich in glucose
|
NO_INTERVENTION: Placebo & depleting
participants will perform in a depleting task and receive a placebo drink
|
|
NO_INTERVENTION: Placebo & non depleting
participants will perform in a non depleting task and receive a placebo drink
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood Glucose Level
Time Frame: baseline, after depleting task
|
baseline, after depleting task
|
self control tasks (handgrip, stroop, figure tracing task)
Time Frame: after 12-minutes metabolizing phase
|
after 12-minutes metabolizing phase
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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, 2012
Primary Completion (ANTICIPATED)
April 1, 2013
Study Completion (ANTICIPATED)
April 1, 2013
Study Registration Dates
First Submitted
March 22, 2012
First Submitted That Met QC Criteria
March 23, 2012
First Posted (ESTIMATE)
March 26, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
March 26, 2012
Last Update Submitted That Met QC Criteria
March 23, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- selfcontrolvsglucose
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.
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