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

NCT ID: NCT01881724

Last Updated: 2013-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

sleep education program

Group Type EXPERIMENTAL

Sleep education

Intervention Type BEHAVIORAL

Interventions

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Sleep education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Alice Pik Shan KONG

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alice PS Kong, FRCP

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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The Chinese University of Hong Kong

Hong Kong, , China

Site Status RECRUITING

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

Hong Kong, Hong Kong, Hong Kong

Site Status NOT_YET_RECRUITING

Countries

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China Hong Kong

Central Contacts

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Alice Kong, FRCP

Role: CONTACT

(852)26323307

Tracy Cheng, RN

Role: CONTACT

(852)26323663

Facility Contacts

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Alice Kong, FRCP

Role: primary

+852 2632 3307

Risa Ozaki, MRCP

Role: backup

+852 2632 3663

Alice Kong, FRCP

Role: primary

(852)26323307

Tracy Cheng, RN

Role: backup

(852)26323663

Other Identifiers

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CUHK466711

Identifier Type: -

Identifier Source: org_study_id

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