- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01091025
Comparing Two Different Approaches in the Screening of Cystic Fibrosis Related Diabetes (CFRD)
A Comparative Analysis of the Clinical Efficacy of Two Approaches in the Screening for Cystic Fibrosis Related Diabetes in Adult With Cystic Fibrosis: i) a Selective Approach; ii) an Unselected Annual Oral Glucose Tolerance Test
The incidence of cystic fibrosis related diabetes (CFRD) has risen significantly as patients' survival improves. Early diagnosis of CFRD is crucial to prevent the unnecessary deterioration of lung function and nutritional status, both of which affect the patient's overall survival. The oral glucose tolerance test (OGGT) is the accepted method for detecting CFRD. The Cystic Fibrosis Trust guidelines (2004) recommend that patients with CF over the age of twelve years should be screened annually. Most hospitals use an annual OGTT. Performing OGTT on all CF patients is inconvenient and may not be cost effective, as patients have to starve overnight and need to spend an extra 2 hours in the hospital in addition to all the other annual review tests. In our centre, a selective approach is used. If patients have an abnormal random blood glucose and /or abnormal glycosylated haemoglobin (HbA1c) and/or symptoms of hyperglycaemia or unexplained weight loss then an OGTT will be performed.
The aims of this study are
- To compare the clinical efficiency in the screening for CFRD in the two different methods: i)a selective approach , ii)an unselected annual OGTT for all patients.
- To compare the cost effectiveness of the two approaches in the screening for CFRD.
Study Overview
Status
Intervention / Treatment
Detailed Description
CFRD affects 30% of all patients with cystic fibrosis (CF) by the age of twenty-five. Early diagnosis of CFRD is crucial to prevent the unnecessary deterioration of pulmonary function and nutritional status, both of which affect the patient's overall survival. The selective approach takes less patient time and is less expensive. If it is equally accurate it should be used routinely. The oral glucose tolerance test (OGTT) is the accepted method for detecting CFRD and the Cystic Fibrosis Trust guidelines recommend that patients with CF over the age of twelve years should be screened annually. Yung et al, questioned this approach and argued that performing OGTT on all CF patients is inconvenient and may not be cost effective, as patients have to starve overnight and need to spend an extra 2 hours in the hospital in addition to all the other annual review tests.
In this study, a selective approach in performing OGTTs in the screening for CFRD will be used; this includes the use of a combination of clinical and biochemical criteria that of abnormal random blood glucose and /or abnormal glycosylated haemoglobin (HbA1c) and/or symptoms of hyperglycaemia, or weight loss.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, SW3 6NP
- Royal Brompton & Harefield NHS Foundation Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- first one hundred consecutive clinically stable patients with CF attending annual review from January 2009
- 16 years of age and over will be eligible for the study.
Exclusion Criteria:
- patients with an existing diagnosis of CFRD.
- patients with an infective exacerbation (i.e. on a new course of antibiotics)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: CF patients without known diagnose of CFRD
There is only one arm.
All patients in the study had the same procedures (ie.
an OGTT).
Investigators used the screening criteria in parallel to this.
|
A study subject has an abnormal OGTT will be referred to a cystic fibrosis consultant who is not involved in the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To identify if using the selective approach to screen for CFRD is as accurate as screening all patients with OGTT at annual review.
Time Frame: 6 months
|
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Which is the more cost effective way of screening all patients with OGTT?
Time Frame: 6 months
|
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maragret E Hodson, Professor, Imperial College London
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRO-1210
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 Screening of Cystic Fibrosis Related Diabetes
-
University of Colorado, DenverCystic Fibrosis FoundationTerminatedCystic Fibrosis-related Diabetes | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in ChildrenUnited States
-
Rhode Island HospitalCystic Fibrosis FoundationRecruitingCystic Fibrosis | Cystic Fibrosis-related Diabetes | Cystic Fibrosis With Intestinal ManifestationsUnited States
-
Herlev and Gentofte HospitalCopenhagen University Hospital, DenmarkActive, not recruitingMyocardial Infarction | Heart Diseases | Heart Failure | Stroke | Cystic Fibrosis | Heart Failure, Diastolic | Heart Failure, Systolic | Left Ventricular Dysfunction | Cystic Fibrosis-related Diabetes | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of Pancreas | Cystic Fibrosis, Pulmonary | Cystic...Denmark
-
University of PortsmouthUniversity Hospital Southampton NHS Foundation Trust; Loughborough University; Queen Alexandra HospitalTerminated
-
Boston Children's HospitalCompletedCystic Fibrosis | Cystic Fibrosis-related Diabetes | Cystic Fibrosis With Intestinal ManifestationsUnited States
-
Dartmouth-Hitchcock Medical CenterTrustees of Dartmouth CollegeWithdrawnCystic Fibrosis-related Diabetes | Cystic Fibrosis Liver Disease | CF - Cystic FibrosisUnited States
-
University of CambridgeUniversity of Oxford; University of EdinburghRecruitingCystic Fibrosis-related DiabetesUnited Kingdom
-
Jagdeesh UllalWake Forest University Health SciencesActive, not recruitingCystic Fibrosis-related DiabetesUnited States
-
Massachusetts General HospitalBeta Bionics, Inc.CompletedCystic Fibrosis-related DiabetesUnited States
-
Johns Hopkins UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Northwestern... and other collaboratorsEnrolling by invitationCystic Fibrosis Related DiabetesUnited States
Clinical Trials on Glucose profile for 2 weeks
-
University of ChicagoRecruitingThumb OsteoarthritisUnited States
-
Beijing Chao Yang HospitalRecruiting
-
St. James's Hospital, IrelandUnknownVaricose VeinsIreland
-
University Hospital Inselspital, BerneBaxter Healthcare CorporationCompletedHemodialysis | AnuriaSwitzerland
-
University of AlbertaEgg Farmers of CanadaRecruitingCancer | Other MalnutritionCanada
-
Texas A&M UniversityUnknownCancer Patients Receiving Chemotherapy or ChemoradiotherapyUnited States
-
Marmara UniversityNot yet recruiting
-
Università Vita-Salute San RaffaeleRecruitingFemale InfertilityItaly
-
University of Tennessee Health Science CenterRegional One HealthUnknownObesity in Pregnancy
-
Jordan Miller, Graduate StudentPhysiotherapy Foundation of CanadaCompletedResponses of People With Neck Pain Being Treated With Varying Doses of Manual Therapy: A Pilot StudyWhiplash InjuriesCanada