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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01881724
Other study ID # CUHK466711
Secondary ID
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


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
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