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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Sleep education
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Chinese University of Hong KongRecruiting
  • Clinical Trial Centre, The Chinese University of Hong Kong, Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

sleep education program

Arm Description

Outcomes

Primary Outcome Measures

Change in HbA1c from baseline

Secondary Outcome Measures

fasting plasma glucose
insulin resistance
HOMA_IR
body weight
blood pressure
lipid profile
sleep duration

Full Information

First Posted
October 18, 2011
Last Updated
June 19, 2013
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01881724
Brief Title
Impact of Sleep Education Program on Glycemic Control in Hong Kong Chinese Type 2 Diabetic Patients
Official Title
Impact of Sleep Education Program on Glycemic Control in Hong Kong Chinese Type 2 Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Title
sleep education program
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Sleep education
Primary Outcome Measure Information:
Title
Change in HbA1c from baseline
Time Frame
12 months
Secondary Outcome Measure Information:
Title
fasting plasma glucose
Time Frame
12 months
Title
insulin resistance
Description
HOMA_IR
Time Frame
12 months
Title
body weight
Time Frame
12 months
Title
blood pressure
Time Frame
12 months
Title
lipid profile
Time Frame
12 months
Title
sleep duration
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-65 years Type 2 diabetes mellitus Chinese ethnicity Able and willing to give informed written consent Sleep deprived, defined as subjective sleeping time <6 hours per day Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alice Kong, FRCP
Phone
(852)26323307
Email
alicekong@cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Tracy Cheng, RN
Phone
(852)26323663
Email
tracycheng@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice PS Kong, FRCP
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
ZIP/Postal Code
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Kong, FRCP
Phone
+852 2632 3307
Email
alicekong@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Risa Ozaki, MRCP
Phone
+852 2632 3663
Email
risaozaki@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Risa Ozaki, MRCP
Facility Name
Clinical Trial Centre, The Chinese University of Hong Kong, Prince of Wales Hospital
City
Hong Kong
ZIP/Postal Code
Hong Kong
Country
Hong Kong
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Kong, FRCP
Phone
(852)26323307
Email
alicekong@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Tracy Cheng, RN
Phone
(852)26323663
Email
tracycheng@cuhk.edu.hk

12. IPD Sharing Statement

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

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