Diabetes in the Very Elderly Trial - DIVET

niversity Hospitals Coventry and Warwickshire NHS Trust0 个研究点开始时间: 2005年5月9日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1) Men and women over the age of 75 at the time of randomisation.
•2) After 2 months of dietary treatment, a HbA1c equal to or greater than 7.5 - equal to or less than 9.0%.
•3) Informed written consent.
•4) No symptom due to uncontrolled diabetes such as recent weight loss, polyuria, thirst or recurrent infection.
•5) No serious diabetic complication such as proliferative retinopathy or sight threatening retinopathy.
•6) No serious cardiovascular event in the previous 2 months.
•7) No life threatening disease which is likely to lead to an early demise.
•8) If previously treated with anti diabetic drugs these should have been stopped at least 2 months previously.
•9) Abbreviated Mental Test Score (MTS) >=7 out of 10 of 5 or 6 the carer to also give informed assent.
•10) Inclusion for metformin treatment
•i) serum creatinine <130umol/1
•ii) no alcohol abuse (normal liver transaminases)
•iii) no congestive heart failure (doses of up to 40mg of Frusemide or equivalent acceptable).
•iv) no liver disease (normal transaminases)
•v) any B12 deficiency must be corrected.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1) Age less than 75 years.
•2) Patient with terminal illness.
•3) Presence of symptoms due to uncontrolled diabetes (recent weight loss, polyuria, thirst or recurrent infection).
•4) Serious diabetic complication (proliferative retinopathy, sight threatening retinopathy).
•5) Serious cardiovascular event in the previous 2 months.
•6) Life threatening disease which is likely to lead to early demise.
•7) Previous demonstration of a definite need for good blood sugar control eg. lactic acidosis.
•8) Unable to provide informed written consent or consent withheld by the principal carer.

发起方

niversity Hospitals Coventry and Warwickshire NHS Trust