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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01881724
• Other study ID #: CUHK466711
• Status: Recruiting
• Phase: N/A
• First received: October 18, 2011
• Last updated: June 19, 2013
• Start date: May 2013
• Est. completion date: December 2017

Study information

• Verified date: June 2013
• Source: Chinese University of Hong Kong
• Contact: Alice Kong, FRCP
• Phone: (852)26323307
• Email: alicekong[@]cuhk.edu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Sleep education

Locations

Country	Name	City	State
China	The Chinese University of Hong Kong	Hong Kong
Hong Kong	Clinical Trial Centre, The Chinese University of Hong Kong, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from baseline		12 months	No
Secondary	fasting plasma glucose		12 months	No
Secondary	insulin resistance	HOMA_IR	12 months	No
Secondary	body weight		12 months	No
Secondary	blood pressure		12 months	No
Secondary	lipid profile		12 months	No
Secondary	sleep duration		12 months	No