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Diabetes MellitusIFG to DMNCT01807351

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

An observational study of Diabetes Mellitus and Hypertension, run by Kowloon Hospital, Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
10,000 participants
Where
No sites listed yet
Study dates
Jul 2012to Dec 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

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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About this study

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

Keywords
Diabetes Mellitus, Hypertension, Impaired Fasting Glucose, Primary Health Care, Chinese
Medical subject headings
Diabetes Mellitus, Hypertension

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 2005 to 2012

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2013 (estimated)
  2. Study startJul 2012
  3. Primary completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
10,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01807351
Sponsor's protocol ID
KWC_REC_5522
Acronym
IFG to DM
Status last verified
Mar 2013
First submitted
7 Mar 2013
Last updated
8 Mar 2013
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus and Hypertension, run by Kowloon Hospital, Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects develope Diabetes Mellitus (time frame: 2005 to 2012). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01807351, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2013.

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IFG to DM Clinical Trial NCT01807351 | AzTrials