UK Prospective Diabetes Study - post study monitoring (PSM) and cohort follow-up (CFU)
| ISRCTN | ISRCTN75451837 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75451837 |
| Secondary identifying numbers | G8109618 (now incorporates G8815630) |
- Submission date
- 17/10/2000
- Registration date
- 17/10/2000
- Last edited
- 22/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Rury R Holman
Scientific
Scientific
Diabetes Trials Unit
OCDEM, Churchill Hospital
Old Road, Headington
Oxford
OX3 7LJ
United Kingdom
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | - |
| Study acronym | UKPDS |
| 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 effects10 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 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 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. |
| Ethics approval(s) | Ethics approval received from the South East Multi-centre Research Ethics Committee on the 20th September 2002 (MREC 02/01/85) |
| Condition | Diabetes |
| Intervention | Diet/insulin/sulphonylurea/metformin in preventing the complications of type 2 diabetes. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Insulin/sulphonylurea/metformin |
| Primary outcome measure | 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 measures | Added 15/08/2008: 1. Quality of life 2. Health economic outcomes 3. Cognitive function |
| Overall study start date | 01/03/1998 |
| Overall study end date | 30/09/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 5102 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/03/1998 |
| Recruitment end date | 30/09/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Diabetes Trials Unit
Oxford
OX3 7LJ
United Kingdom
OX3 7LJ
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
University of Oxford Diabetes Trials Unit
University/education
University/education
Sponsor for the cohort follow-up
OCDEM
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
England
United Kingdom
| Phone | +44 (0)1865 857242 |
|---|---|
| dtu@dtu.ox.ac.uk |
Funders
Funder type
Industry
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Several pharmaceutical companies
No information available
Other organisations
No information available
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
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | UKPDS results: | 12/09/1998 | Yes | No | |
| Results article | UKPDS results: | 12/09/1998 | Yes | No | |
| Results article | UKPDS results: | 12/09/1998 | Yes | No | |
| Results article | UKPDS results: | 12/09/1998 | Yes | No | |
| Results article | results of 10-year follow-up of intensive glucose control: | 09/10/2008 | Yes | No | |
| Results article | results of long-term follow-up after tight control of blood pressure: | 09/10/2008 | Yes | No | |
| Results article | results | 05/03/2013 | Yes | No | |
| Results article | UKPDS results | 01/03/2020 | 10/02/2020 | Yes | No |
| Results article | UKPDS 89 results | 01/08/2021 | 04/10/2021 | Yes | No |
| Results article | UKPDS 91 results | 17/05/2024 | 22/05/2024 | Yes | No |
Editorial Notes
22/05/2024: Publication reference added.
04/10/2021: Publication reference added.
10/02/2020: Publication reference added.
