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

June 19, 2013 updated by: 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China, Hong Kong
        • Recruiting
        • The Chinese University of Hong Kong
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Risa Ozaki, MRCP
  • Hong Kong
      • Hong Kong, Hong Kong, Hong Kong
        • Not yet recruiting
        • Clinical Trial Centre, The Chinese University of Hong Kong, Prince of Wales Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Experimental: sleep education program
Behavioral: Sleep education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c from baseline
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure
Time Frame: 12 months
12 months
body weight
Time Frame: 12 months
12 months
fasting plasma glucose
Time Frame: 12 months
12 months
insulin resistance
Time Frame: 12 months
HOMA_IR
12 months
lipid profile
Time Frame: 12 months
12 months
sleep duration
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Alice PS Kong, FRCP, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 18, 2011

First Submitted That Met QC Criteria

June 19, 2013

First Posted (Estimate)

June 20, 2013

Study Record Updates

Last Update Posted (Estimate)

June 20, 2013

Last Update Submitted That Met QC Criteria

June 19, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUHK466711

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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