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

This study is not yet open for participant recruitment.
Verified March 2012 by The University of Hong Kong
Sponsor:
Collaborator:
Queen Mary Hospital, Hong Kong
Information provided by (Responsible Party):
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01563016
First received: March 22, 2012
Last updated: March 23, 2012
Last verified: March 2012
History of Changes
  Purpose

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.

Condition Intervention
Schizophrenia
 Dietary Supplement: glucose drink

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Glucose as a Mediator of Self-control Performances in Patients With Schizophrenia: A Randomized Controlled Study

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Blood Glucose Level [ Time Frame: baseline, after depleting task ] [ Designated as safety issue: No ]
  • self control tasks (handgrip, stroop, figure tracing task) [ Time Frame: after 12-minutes metabolizing phase ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glucose & Depleting
participants will perform in a depleting task and receive a glucose drink
 Dietary Supplement: 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
 Dietary Supplement: 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

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563016

Contacts
Contact: Eric YH Chen, MD 852-22553063 eyhchen@hku.hk
Contact: Chung-Ming Leung, Bsc 852-64054460 mingming4f29@hotmail.com

Locations
China
The University of Hong Kong Not yet recruiting
Hong Kong, China
Contact: Bonnie Choi         bwschoi@hku.hk    
Sponsors and Collaborators
The University of Hong Kong
Queen Mary Hospital, Hong Kong
Investigators
Principal Investigator: Eric YH Chen, MD The University of Hong Kong
  More Information

No publications provided

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01563016     History of Changes
Other Study ID Numbers: selfcontrolvsglucose
Study First Received: March 22, 2012
Last Updated: March 23, 2012
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
schizophrenia
Psychotic Disorders
Psychoses

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013