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

March 7, 2013 updated by: Mr. Stephen Cho, Kowloon Hospital, Hong Kong
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.

Study Overview

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

Study Type

Observational

Enrollment (Actual)

10000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects develope Diabetes Mellitus
Time Frame: 2005 to 2012

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

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Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 7, 2013

First Submitted That Met QC Criteria

March 7, 2013

First Posted (Estimate)

March 8, 2013

Study Record Updates

Last Update Posted (Estimate)

March 8, 2013

Last Update Submitted That Met QC Criteria

March 7, 2013

Last Verified

March 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

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