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| [ Print-friendly version ] |
| UK Prospective Diabetes Study - post study monitoring (PSM) and cohort follow-up (CFU) |
| ISRCTN | ISRCTN75451837 |
| DOI | 10.1186/ISRCTN75451837 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | UK Prospective Diabetes Study - post study monitoring (PSM) and cohort follow-up (CFU) |
| Scientific title | |
| Acronym | UKPDS |
| Serial number at source | G8109618 (now incorporates G8815630) |
| Study hypothesis |
Please note that as of 15/08/2008 this record has been extensively updated and now includes a follow-up study. All details pertaining to these updates can be found in the relevant field under the above update date. At this time, the title of this trial was changed to the above; the previous title was: ‘UK prospective diabetes study - post-study monitoring (PSM)’. Please also note that the anticipated end-date of this trial was extended to 31/12/2007; the previous anticipated end date was 30/09/2002.
Current hypothesis as of 15/08/2008: To determine whether improved blood glucose control will prevent the complications of type 2 diabetes, and whether any mode of therapy, diet, insulin, sulphonylurea or metformin, has specific advantages or disadvantages. The trial showed that improved blood glucose and blood pressure control did lead to a reduction in the incidence of complications of type 2 diabetes. All contactable surviving patients from the trial are being followed up during the post-study monitoring and the cohort follow-up phases, to track any changes in the incidence of complications. There is no further intervention in these phases. Physicians are responsible for each patient’s care. The PSM and CFU phases of the study are examining possible “legacy effects” 10 years post-trial of earlier randomised allocation to more intensive blood glucose and/or blood pressure control. Previous hypothesis: To determine whether improved blood glucose control will prevent the complications of type two diabetes, and whether any mode of therapy, diet, insulin, sulphonylurea or metformin, has specific advantages or disadvantages. The trial showed that improved blood glucose and blood pressure control did lead to a reduction in the incidence of complications of type two diabetes. All contactable surviving patients from the trial are being followed up during the post-study monitoring phase, to track any changes in the incidence of complications. There is no further intervention in this phase. Physicians responsible for each patient's care. |
| Lay summary | Not provided at time of registration |
| Ethics approval |
Added 15/08/2008:
Ethics approval received from the South East Multi-centre Research Ethics Committee on the 20th September 2002 (MREC 02/01/85) |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Diabetes |
| Participants - inclusion criteria |
1. Newly diagnosed type 2 diabetic patients
2. Aged 25 - 65 years inclusive (median age 52 years) 3. Two fasting plasma glucose concentrations more than 6 mmol/l |
| Participants - exclusion criteria |
1. Severe vascular disease
2. Accelerated hypertension 3. Proliferative or pre-proliferative retinopathy 4. Renal failure 5. Other life threatening diseases an illness requiring systematic steroids 6. An occupation that precluded insulin therapy 7. Language difficulties 8. Ketouric greater than 3 millimols per litre suggestive of insulin dependent diabetes |
| Anticipated start date | 01/03/1998 |
| Anticipated end date | 30/09/2002 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 5102 |
| Interventions |
Diet/insulin/sulphonylurea/metformin in preventing the complications of type 2 diabetes.
Added 15/08/2008: Sponsor details for the cohort follow-up: University of Oxford Diabetes Trials Unit OCDEM, Churchill Hospital Old Road, Headington Oxford OX3 7LJ United Kingdom Tel: +44 (0)1865 857242 Fax: +44 (0)1865 857241 Email: dtu@dtu.ox.ac.uk |
| Primary outcome measure(s) |
1. Diabetes related mortality: deaths from heart attacks, sudden death, stroke, complications from peripheral vascular disease or amputations, renal failure, hyperglycaemic or hypoglycaemic coma.
2. Total mortality 3. Diabetes related mortality and major clinical endpoints, including non-fatal myocardial infarct, clinical angina with confirmatory abnormal ECG, heart failure, major stroke, retinal photocoagulation, vitreous haemorrhage, blindness, renal failure |
| Secondary outcome measure(s) |
Added 15/08/2008:
1. Quality of life 2. Health economic outcomes 3. Cognitive function |
| Sources of funding |
1. Medical Research Council (MRC) (UK)
2. Several pharmaceutical companies 3. Other organisations For a full list of sources of funding for this trial, please visit the trial website at http://www.dtu.ox.ac.uk/ukpds/funding.php |
| Trial website | http://www.dtu.ox.ac.uk/ukpds |
| Publications |
Results of the main trial:
1. UKPDS 33 results: http://www.ncbi.nlm.nih.gov/pubmed/9742976 2. UKPDS 34 results: http://www.ncbi.nlm.nih.gov/pubmed/9742977 3. UKPDS 38 results: http://www.ncbi.nlm.nih.gov/pubmed/9732337 4. UKPDS 39 results: http://www.ncbi.nlm.nih.gov/pubmed/9732338 5. 2008 results of long-term follow-up after tight control of blood pressure: http://www.ncbi.nlm.nih.gov/pubmed/18784091 6. 2008 results of 10-year follow-up of intensive glucose control: http://www.ncbi.nlm.nih.gov/pubmed/18784090 7. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23362315 |
| Contact name | Dr Rury R Holman |
| Address |
Diabetes Trials Unit
OCDEM, Churchill Hospital Old Road, Headington |
| City/town | Oxford |
| Zip/Postcode | OX3 7LJ |
| Country | United Kingdom |
| Tel | +44 (0)1865 857240 |
| Fax | +44 (0)1865 857241 |
| rury.holman@dtu.ox.ac.uk | |
| Sponsor | Medical Research Council (MRC) (UK) |
| Address | 20 Park Crescent |
| City/town | London |
| Zip/Postcode | W1B 1AL |
| Country | United Kingdom |
| Tel | +44 (0)20 7636 5422 |
| Fax | +44 (0)20 7436 6179 |
| clinical.trial@headoffice.mrc.ac.uk | |
| Sponsor website: | http://www.mrc.ac.uk |
| Date applied | 17/10/2000 |
| Last edited | 04/02/2013 |
| Date ISRCTN assigned | 17/10/2000 |
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| © 2013 ISRCTN unless otherwise stated. | |
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