NCT01807351

Brief Summary

Retrospective cohort of all the patients with elevated blood sugar (but no Diabetes) attending the study sites from 2002 to 2007. We retrieval their records to see how many of them actually developed diabetes. The patient's record will be followed up to 6 years after their first abnormally high blood sugar checked. We will measure their parameters including sex, age, pay code and whether they have hypertension or not to see what factors will increase risk of DM development.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Status
completed

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

Study Start

First participant enrolled

July 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
Last Updated

March 8, 2013

Status Verified

March 1, 2013

Enrollment Period

5 months

First QC Date

March 7, 2013

Last Update Submit

March 7, 2013

Conditions

Keywords

Diabetes MellitusHypertensionImpaired Fasting GlucosePrimary Health CareChinese

Outcome Measures

Primary Outcomes (1)

  • Number of subjects develope Diabetes Mellitus

    We use the subject list drawn by the above criterion to retrieval the subsequent attendance record results annually (see Table 1 for the study method). Subjects are defined to have diagnosis of diabetes if they have physician coded of T90 or they have been prescribed of antidiabetic drugs (BNF(24) section 6.1 and 6.2). Each subjects of the cohort was followed to the date of IFG diagnosis and date of T2DM diagnosis. For IFG subjects who fulfilled the DM diagnosis criteria twice, only the earliest occurrence of T2DM diagnosis was recorded. Other outcomes we are going to measure include age, sex, paying status in the consultation we first diagnosed to have IFG. We will see whether they have physician diagnosis of hypertension by coding International Classification of Primary Care (ICPC-2) coded as K86 uncomplicated hypertension or K87 complicated hypertension, or they have been prescribed with antihypertensive drugs (British National Formulary BNF(24) section 2.5).

    2005 to 2012

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We included all subjects with impaired fasting glucose results from Jan 2002 to Dec 2007. Most of the subjects are hypertension patients visiting 6 general outpatient clinics located in Sham Shui Po, Wong Tai Sin, Yau Mei Tei in Kowloon, Tsuen Wan in New territories of Hong Kong. Minority of subjects had blood taken for other reasons. All the laboratory results and dispensing records in the selected study centres are computerized and accessible from 2002. The reasons of consultation are coded by attending doctors by International Classification of Primary Care (ICPC-2). The ICPC-2 coding rate and quality are generally satisfactory(22). Locally the study centre ICPC-2 coding rate is over 99% in all consultations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fu SN, Luk W, Wong CK, Cheung KL. Progression from impaired fasting glucose to type 2 diabetes mellitus among Chinese subjects with and without hypertension in a primary care setting. J Diabetes. 2014 Sep;6(5):438-46. doi: 10.1111/1753-0407.12120. Epub 2014 Feb 18.

MeSH Terms

Conditions

Diabetes MellitusHypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Fu Sau Nga

Study Record Dates

First Submitted

March 7, 2013

First Posted

March 8, 2013

Study Start

July 1, 2012

Primary Completion

December 1, 2012

Last Updated

March 8, 2013

Record last verified: 2013-03