Diabetologia

, Volume 34, Issue 12, pp 877–890 | Cite as

UK prospective diabetes study (UKPDS)

VIII. Study design, progress and performance
  • UK Prospective Diabetes Study Group
Originals

Summary

The UK Prospective Diabetes Study (UKPDS) is a multi-centre, prospective, randomised, intervention trial of 5100 newly-diagnosed patients with Type 2 (non-insulin-dependent) diabetes mellitus which aims to determine whether improved blood glucose control will prevent complications and reduce the associated morbidity and mortality. Newly presenting Type 2 diabetic patients aged 25–65 years inclusive, median age 53 years, median body mass index 28 kg/m2 and median fasting plasma glucose 11.3 mmol/l, were recruited and treated initially by diet. Ninety five percent remained hyperglycaemic (fasting plasma glucose > 6 mmol/l) and were randomly allocated to different therapies. In the main randomisation, those who were asymptomatic and had fasting plasma glucose under 15 mmol/l were allocated either to diet policy, or to active policy with either insulin or sulphonylurea aiming to reduce the fasting plasma glucose to under 6 mmol/l. Over 3 years, the median fasting plasma glucose in those allocated to diet policy was 8.9 mmol/l compared with 7.0 mmol/l in those allocated to active policy. The Hypertension in Diabetes Study has been included in a factorial design to assess whether improved blood pressure control will be advantageous. Patients with blood pressure ≥ 160/90 mm Hg were randomly allocated to tight control aiming for < 150/85 mm Hg with either an angiotensin-converting enzyme inhibitor or a Beta-blocker or to less tight control aiming for < 200/105 mm Hg. The endpoints of the studies are major clinical events which affect the life and well-being of patients, such as heart attacks, angina, strokes, amputations, blindness and renal failure. To date, 728 patients have had at least one clinical endpoint. Surrogate endpoints include indices of macrovascular and microvascular disease detected by ECG with Minnesota Coding, retinal colour photography and microalbuminuria. The studies also aim to evaluate potential risk factors for the development of diabetic complications such as smoking, obesity, central adiposity, plasma LDL-and HDL-cholesterol, triglyceride, insulin, urate and other biochemical variables. The studies are planned to terminate in 1994, with a median follow-up of 9 years (range 3–16 years) for the glucose study and 5 years (range 2–6 years) for the hypertension study.

Key words

Type 2 (non-insulin-dependent) diabetes mellitus hypertension complications clinical trial glycaemic control blood pressure control 

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Copyright information

© Springer-Verlag 1991

Authors and Affiliations

  • UK Prospective Diabetes Study Group
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
    • 7
    • 8
    • 9
    • 10
    • 11
    • 12
    • 13
    • 14
    • 15
    • 16
    • 17
    • 18
    • 19
    • 20
    • 21
  1. 1.Radcliffe InfirmaryOxford
  2. 2.Royal InfirmaryAberdeen
  3. 3.General HospitalBirmingham
  4. 4.St George's Hospital and Hammersmith HospitalLondon
  5. 5.City HospitalBelfast
  6. 6.North Staffordshire Royal InfirmaryStoke-on-Trent
  7. 7.Royal Victoria HospitalBelfast
  8. 8.St. Helier HospitalCarshalton
  9. 9.Whittington HospitalLondon
  10. 10.Norfolk and Norwich HospitalUK
  11. 11.Lister HospitalStevenage
  12. 12.Ipswich HospitalUK
  13. 13.Ninewells HospitalDundee
  14. 14.Northampton HospitalUK
  15. 15.Torbay Hospital, Peterborough General HospitalUK
  16. 16.Scarborough HospitalUK
  17. 17.Derbyshire Royal InfirmaryUK
  18. 18.Manchester Royal InfirmaryUK
  19. 19.Hope HospitalSalford
  20. 20.Leicester General HospitalUK
  21. 21.Royal Devon and Exeter HospitalExeterUK

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