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CompletedNCT01807351IFG to DMUpdated Mar 8, 2013

Progression From Impaired Fasting Glucose to Type 2 Diabetes Mellitus Among Subjects With and Without Hypertension in Primary Care Setting

An observational study in Diabetes Mellitus, Hypertension and Impaired Fasting Glucose, sponsored by Kowloon Hospital, Hong Kong. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-08.

Sponsored by Kowloon Hospital, Hong Kong · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

We aim at find out the progression of impaired fasting glucose (IFG) to type 2 Diabetes Mellitus (T2DM) among patients in general practice setting. We can understand the progress of the target patients so as to improve patient education, improve patient motivation in lifestyle modification.We are going to find out the annual incidence of Type 2 DM developement among the patients with and without hypertension Hypertensive patients with impaired fasting glucose are more likely to develop type 2 diabetes mellitus compare with normal tensive patients

02

Conditions studied

  • Diabetes Mellitus
  • Hypertension
  • Impaired Fasting Glucose

Keywords

  • Diabetes Mellitus
  • Hypertension
  • Impaired Fasting Glucose
  • Primary Health Care
  • Chinese
03

In context

Diabetes Mellitus

11,090 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 10,000 is above the median of 234 across 2,254 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Kowloon Hospital, Hong Kong is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Eligibility criteria

Inclusion Criteria:We include all subjects age ≥18 attended the study centers with laboratory diagnosis of IFG by blood sugar 6.1 mmol/l to 6.9 mmol/l checked from 2002 to 2007 in the 6 study centres.

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Exclusion Criteria:We excluded the subjects who have diagnosis of T2DM the years prior to the year of blood taken. We define T2DM by physician coding ICPC-2 of T90 Diabetes non-insulin dependent or prescription of antidiabetic drugs (British National Formulary(23) (BNF) section 6.1 and 6.2). We exclude the patients who had been admitted to Hong Kong Hospital Authority (HKHA)or attended HKHA specialty Clinic, or attended any GOPC with dispensing history of drug used in diabetes in BNF Section 6.1.1 insulins or 6.1.2 anti-diabetic drugs, or with ICPC coded with T90) during 1 Jan 2005 - 31 Dec 2006 (i.e. 2 year prior to starting of study period). We also excluded patient with the date of diagnosis of DM by above criteria earlier than the date of laboratory test results of IFG.

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05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10,000 participants (actual)
Patient registry
No
06

What researchers measure

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).

    Time frame: 2005 to 2012

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 24393475 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01807351
Lead sponsor
Kowloon Hospital, Hong Kong
Responsible party
Mr. Stephen Cho (Dr. Fu Sau Nga, Kowloon Hospital, Hong Kong) — Principal investigator
First posted
Mar 8, 2013
Start date
Jul 2012
Primary completion
Dec 2012
Last update
Mar 8, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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