NCT01881724

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2011

Completed
1.5 years until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 20, 2013

Status Verified

June 1, 2013

Enrollment Period

3.6 years

First QC Date

October 18, 2011

Last Update Submit

June 19, 2013

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c from baseline

    12 months

Secondary Outcomes (6)

  • fasting plasma glucose

    12 months

  • insulin resistance

    12 months

  • body weight

    12 months

  • blood pressure

    12 months

  • lipid profile

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Usual Care

NO INTERVENTION

sleep education program

EXPERIMENTAL
Behavioral: Sleep education

Interventions

Sleep educationBEHAVIORAL
sleep education program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Chinese University of Hong Kong

Hong Kong, Hong Kong, China

RECRUITING

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

Hong Kong, Hong Kong, Hong Kong, Hong Kong

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Alice PS Kong, FRCP

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice Kong, FRCP

CONTACT

(852)26323307alicekong@cuhk.edu.hk

Tracy Cheng, RN

CONTACT

(852)26323663tracycheng@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 18, 2011

First Posted

June 20, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

June 20, 2013

Record last verified: 2013-06

Locations

CN(1)HK(1)