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
Chinese University of Hong Kong
Information provided by (Responsible Party):
Alice Pik Shan KONG, Chinese University of Hong Kong
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
Type 2 Diabetes Mellitus
Behavioral: Sleep education
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Aged 18-65 years
Type 2 diabetes mellitus
Able and willing to give informed written consent
Sleep deprived, defined as subjective sleeping time <6 hours per day
Type 1 diabetes mellitus
Known history of psychiatric disorders (e.g. depression, anxiety, dementia)
Sleep disorders secondary to another medical condition (e.g. obstructive sleep apnoea (OSA), circadian rhythm sleep disorder)
Concomitant chronic medical condition that was likely to be the cause of sleep problem (e.g. benign prostatic hypertrophy, chronic pain)
Concurrent use of hypnotic drugs, psychotic medications and any drugs that are known to affect sleep.
Any condition, as judged by the investigators, as ineligible to participate in this study