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

Not Applicable

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Behavioral: Sleep education

• Registration Number: NCT01881724
• Lead Sponsor: Chinese University of Hong Kong

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.

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 Timeline

• Study First Submitted: 2011-10-18
• Study Start: 2013-05
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-19
• Last Update Submitted: 2013-06-19
• Study First Posted: 2013-06-20
• Last Update Posted: 2013-06-20
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 264

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sleep education program	Sleep education	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline	12 months

Secondary Outcome Measures

Name	Time	Method
fasting plasma glucose	12 months
insulin resistance	12 months	HOMA_IR
body weight	12 months
blood pressure	12 months
lipid profile	12 months
sleep duration	12 months

Trial Locations

Locations (2)

Clinical Trial Centre, The Chinese University of Hong Kong, Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong

The Chinese University of Hong Kong; 🇨🇳 Hong Kong, China