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Impact of Sleep Education Program on Glycemic Control in Hong Kong Chinese Type 2 Diabetic Patients

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ClinicalTrials.gov Identifier: NCT01881724
Recruitment Status : Unknown
Verified June 2013 by Alice Pik Shan KONG, Chinese University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : June 20, 2013
Last Update Posted : June 20, 2013
Sponsor:
Information provided by (Responsible Party):
Alice Pik Shan KONG, Chinese University of Hong Kong

Study Description
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Brief Summary:
This is a randomized controlled trial with 12 month sleep education as intervention, followed by a 12 month observational period, to study whether sleep education would improve glycemic control and cardiometabolic profile of sleep deprived type 2 diabetic patients and evaluate the neurohormonal changes associated with sleep education.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: Sleep education Not Applicable

Detailed Description:
Patients will be identified from the Diabetes Mellitus and Endocrine Centre of Prince of Wales Hospital and Yao Chung Kit Diabetes Assessment Centre, The Chinese University of Hong Kong. All participants will have diabetes complications screening and comphrensive evaluations for glycemic control and cardiometabolic risk factors.Eligible subjects will be randomized to 2 groups (usual or conventional care versus intervention with sleep education program) for 12 months.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Impact of Sleep Education Program on Glycemic Control in Hong Kong Chinese Type 2 Diabetic Patients
Study Start Date : May 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Usual Care
Experimental: sleep education program Behavioral: Sleep education


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c from baseline [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. fasting plasma glucose [ Time Frame: 12 months ]
  2. insulin resistance [ Time Frame: 12 months ]
    HOMA_IR

  3. body weight [ Time Frame: 12 months ]
  4. blood pressure [ Time Frame: 12 months ]
  5. lipid profile [ Time Frame: 12 months ]
  6. sleep duration [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 18-65 years
  2. Type 2 diabetes mellitus
  3. Chinese ethnicity
  4. Able and willing to give informed written consent
  5. Sleep deprived, defined as subjective sleeping time <6 hours per day

Exclusion Criteria:

  1. Type 1 diabetes mellitus
  2. Known history of psychiatric disorders (e.g. depression, anxiety, dementia)
  3. Sleep disorders secondary to another medical condition (e.g. obstructive sleep apnoea (OSA), circadian rhythm sleep disorder)
  4. Concomitant chronic medical condition that was likely to be the cause of sleep problem (e.g. benign prostatic hypertrophy, chronic pain)
  5. Concurrent use of hypnotic drugs, psychotic medications and any drugs that are known to affect sleep.
  6. Any condition, as judged by the investigators, as ineligible to participate in this study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881724


Contacts
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Contact: Alice Kong, FRCP (852)26323307 alicekong@cuhk.edu.hk
Contact: Tracy Cheng, RN (852)26323663 tracycheng@cuhk.edu.hk

Locations
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China
The Chinese University of Hong Kong Recruiting
Hong Kong, China, Hong Kong
Contact: Alice Kong, FRCP    +852 2632 3307    alicekong@cuhk.edu.hk   
Contact: Risa Ozaki, MRCP    +852 2632 3663    risaozaki@cuhk.edu.hk   
Sub-Investigator: Risa Ozaki, MRCP         
Hong Kong
Clinical Trial Centre, The Chinese University of Hong Kong, Prince of Wales Hospital Not yet recruiting
Hong Kong, Hong Kong, Hong Kong
Contact: Alice Kong, FRCP    (852)26323307    alicekong@cuhk.edu.hk   
Contact: Tracy Cheng, RN    (852)26323663    tracycheng@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Alice PS Kong, FRCP Chinese University of Hong Kong
More Information
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Responsible Party: Alice Pik Shan KONG, Associate Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01881724    
Other Study ID Numbers: CUHK466711
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases