Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00400

2 Trial Registration Date

2014-03-31

i Registration Status

Prospective

3 Secondary IDs

CRE-2014.018

4 Source(s) of Funding

Gereral Research Fund applied and result will be notified on June 2014

5 Primary Sponsor

The Nethersole School of Nursing, The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Prof. Chair Sek Ying

ii Address

Rm 825, 8/F, Esther Lee Building, Chinese University of Hong Kong, Shatin, N.T.

iii Phone

39436225

iv Email

sychair@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Chair Sek Ying

ii Address

Rm 825, 8/F, Esther Lee Building, Chinese University of Hong Kong, Shatin, N.T.

iii Phone

39436225

iv Email

sychair@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Determining screening strategies for early detection of pre-diabetes and undiagnosed type 2 diabetes among Hong Kong Chinese aged 35 to 65 years

10 Public Title

Screening strategies for early detection of pre-diabetes and undiagnosed type 2 diabetes

i Public Title in Chinese 研究名稱

釐定糖尿病前期和未確診的二型糖尿病篩查策略

11 Short Title (Optional)

Screening strategies for early detection of pre-diabetes and undiagnosed type 2 diabetes

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-03-10

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Diabetes

15 Intervention

i Types of intervention

Other

Please specify

This is not an interventional study

ii Description/ name of Intervention/article

This is not an interventional study

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

This is not an interventional study

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

This is not an interventional study

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. Aged between 35 and 65 years
2. Chinese ethnicity
3. No history of any type of diabetes
4. Able and willing to give informed written consent

ii Exclusion Criteria

1. Diagnosed with diabetes mellitus
2. Unable to complete a questionnaire interview
3. Unable to undergo a standard 75g oral glucose tolerance test in the designated clinic

iii Age Minimum

35

iv Age Maximum

65

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-09-01

21 Target Sample Size

2400

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

The most cost-effect diabetes screening strategy identify pre-diabetes and undiagnosed type 2 diabetes will be developed based on the collected data

24 Secondary Outcome

N/A

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-05-02

27 Primary Registry and Trial Identifying Number

ChiCTR-OCS-14004457

28 Date of Registration in Primary Registry

2014-04-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2014-04-07