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Department of Paediatrics |
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| School of Clinical Medicine > Department of Paediatrics |
About the Clinical Trials Unit Director: Professor David Dunger The Cambridge Paediatric Diabetes and Endocrinology Clinical Trials Unit was established in 2000 with support from the British Society for Paediatric Endocrinology and Diabetes. The CTU’s aim is to support investigators to set up new studies and to join studies already in progress. The main office is in the University Department of Paediatrics in Cambridge with key staff also in Glasgow and Manchester. The CTU still receives some support from BSPED; however many of its staff are now supported from specific research grants for CTU-run studies. CTU
staff can offer advice on ethics submissions and obtaining MHRA
approval, as well as establishing appropriate operating procedures to
carry out studies according to standards of Good Clinical Practice.
Staff can also offer advice on protocol development, data handling,
randomisation and data entry. Where sufficient funds are in place, they
can also provide study coordination, data management and monitoring. BSPED Clinical Trials Unit University of Cambridge Department of Paediatrics Box 116, Level 8, Addenbrooke’s Hospital Hills Road, Cambridge, CB2 0QQ Tel: (01223) 769386 E-mail We are not able to respond to queries from members of the general public.
CTU Staff – CTU Office, Cambridge Click on names to send that person an e-mail
BSPED Clinical Trials Unit University of Cambridge Department of Paediatrics Box 116, Level 8 Addenbrooke’s Hospital Hills Road Cambridge, CB2 0QQ Unit Director – Prof. David Dunger Tel: (01223) 762 943 CTU Administrator – Anna Diaz Tel: (01223) 769 386 Trials Monitor – Diane Picton Tel: (01223) 762 944 Clinical Trials Co-ordinator - Emma-Jane Gault Tel: (0141) 201 6952
Trials Assistant – Tracey Stevens Tel: (01223) 768 613 Research Nurse – Catherine Fullah Tel: (01223) 763 405 Research Nurse – Jennifer Ashford Tel: 01223 768 025 Senior Data Manager – Laura Tebbs Data Manager – Mark Wilson Tel: (01223) 763 131 Data Manager – James Heywood Tel: (01223) 768 616 Administrator – TBC Data Entry – Sharon Kilker CTU Staff – Scotland University
of Glasgow
Department of Child
Health Yorkhill Staff
in Glasgow
support several large BSPED studies and will assist investigators in
the north
of
BSPED Clinical Trials Co-ordinator – Emma-Jane Gault Tel: (0141) 201 6952 Research Assistant – Sheena McGowan Tel: (0141) 201 0502 Clinical Trials Pharmacy Technician – Sarah Casey Pharmacy Department, Yorkhill Hospitals, Glasgow, G3 8SH Tel: (0141) 201 9367
CTU Staff – North West The
Royal Hospital
Road Pendlebury M27
4HA Research Nurse, North West – Ann McGovern CTU Staff – Midlands Birmingham Children's Hospital Whittall Street Birmingham B4 6NH Research Nurse - Tracey Kirkwood Other proposed CTU Staff There
are proposals for
a BSPED-supported research nurse, to support BSPED
trials based in Statistical Support The
CTU has close links
with several centres which
provide statistical support for CTU studies:
We
have worked
particularly closely with:
The
CTU has close links
with centres providing
specialist support throughout the UK,
including:
The
CTU
currently
supports a
number of trials and other research projects. Most studies have similar
requirements with regard to review by local ethics committees and
management
approval from NHS organisations although some studies are exempt from
needing site-specific
approval from Local Research Ethics Committees.
Closed
to Recruitment: AdDIT: Adolescent type 1 Diabetes cardio-renal Intervention Trial A large multi-centre multi-national intervention study looking at the effect of ACE inhibitors and statins in adolescents with Type 1 Diabetes and high albumin excretion. • Chief Investigator: Professor David Dunger • Project Co-ordinator: Stella Silvester During adolescence, rapid growth and poor glycaemic control contribute to the complication risk associated with microalbuminuria. Early intervention in adolescence with ACE inhibitors and statin therapy may provide cardio-renal protection in high risk subjects resulting in long-term improvements in prognosis. Aim: To determine in a 2x2 factorial double blind placebo controlled parallel group trial whether intervention with ACE inhibitors, statins or a combination of both drugs in high risk subjects will: 1) Reduce albumin excretion and prevent decline in renal function 2) Reduce CVD risk 3) Be well tolerated by patients 4) Be a cost effective treatment Start date: January 2007 Trial Status: Recruiting until June 2011 Contact: Stella Silvester A randomised study of two anti-thyroid drug treatment regimens in young people with thyrotoxicosis. • Principal Chief Investigator: Dr Tim Cheetham • Trial Manager: Christine Harle Aim: To compare the advantages and disadvantages of the two main antithyroid drug treatment regimens in young people with hyperthyroidism by: 1) Determining remission rates 1 and 3 years post-treatment. 2) Determining the amount of time that patients have abnormal biochemical indices whilst on treatment Start date: September 2004 End date: January 2013 Trial status: Recruitment is ongoing with a view to recruiting 160 participants throughout the UK. Currently 74 patients have been recruited at 15 sites. Referrals are welcome: please contact Christine Harle below. Contact: Christine Harle Tel.: 0191 2464591• Principal Investigator: Tim Barrett • Project Co-ordinator: Zoe Gray Aim: This study will characterise young people with Type 2 diabetes for future intervention studies. The BSPED CTAG is custodian of the database. Start date: August 2009 End date: April 2012 Trial status: Currently 104 subjects from 48 sites have been recruited to the study. Contact: Zoe Gray Establishment of a national register of UK women with Turner syndrome aged 16 yrs and over • Chief Investigator: Professor David Dunger • Project Co-ordinator: Emma-Jane Gault/Anna Diaz Aim: To monitor the provision of medical care for Turner Syndrome patients in adolescence and adulthood. The quality and range of the medical care that women with Turner syndrome receive can vary greatly after they leave their childhood consultant and enter adult health services. The Register will allow the collection of information about childhood medical care as well as playing a useful role in monitoring ongoing medical management. Start date: December 2004 End date: Ongoing Trial status: Patients who have left paediatric care can now refer themselves directly without going through their consultant. However, referrals from paediatricians are still welcome as well. Contact Anna Diaz for more information at the address below. Contact: Anna Diaz NESGAS (North European Small for Gestational Age Study) A randomised multicentre, multinational trial evaluating the safety & efficacy of GH treatment at varying doses in short children, born small-for-gestational-age (SGA) • Principal Investigators (UK): Professor David Dunger, Dr Malcolm Donaldson, Dr Jeremy Kirk • Project Co-ordinator (UK): Emma-Jane Gault • Researchers (UK): Catherine Fullah (Cambridge); Tracey Kirkwood (Birmingham); Sheena McGowan (Glasgow) Aim: To determine the safety & efficacy of 3 different GH treatment regimens in SGA children – high dose, low dose and dose titration according to IGF-I levels Start date: September 2004 End date: December 2008 Trial status: Recruitment to NESGAS closed in 2009. An extension study to follow-up these participants until final height is underway. The primary objectives are to evaluate changes in insulin sensitivity/secretion and impaired glucose tolerance. Secondary outcomes are growth, body composition and cardiovascular risk factors. Contact: Catherine Fullah UK Genetic Resource Investigating Diabetes • Principal Investigator: Professor David Dunger • Project Co-ordinator: TBC Aims: 1) To establish cell lines from 10,000 cases with type 1 diabetes diagnosed under 16 years and 10,000 ethnically matched controls to obtain a permanent source of DNA. 2) High throughput genotyping of the DNA samples to compare allele frequencies in cases with controls to map & identify genes for type 1 diabetes. 3) Biochemical & functional analyses of genes and their expression to differentiate between the functions & role of alleles predisposing to & protective of disease Start date: January 2001 Trial status: Over 10,000 samples have been collected from over 100 UK centres. The DNA samples are available to the wider scientific community through the JDRF/Wellcome Trust Access Committee. Contact: Mark Wilson NIRTURE: Neonatal Insulin Replacement Therapy in Europe A Randomised, Controlled Trial of Early Insulin Therapy in Very Low Birth Weight Infants • Principal Investigator: Professor David Dunger • Project Co-ordinator: Di Picton Start date: September 2004 End date: November 2009 Trial status: Recruitment has now closed. 389 subjects were recruited (recruited from the U.K.: 108, recruited in Europe: 281). Of the 389, 49 died and 18 were withdrawn. Early insulin therapy offers little clinical benefit in very-low-birth-weight infants. It reduces hyperglycaemia but may increase risk of hypoglycaemia. Publications: Beardsall K, Vanhaesebrouck S, Ogilvy-Stuart AL, Vanhole C, Palmer CR, Ong K, vanWeissenbruch M, Midgley P, Thompson M, Thio M, Cornette L, Ossuetta I, Iglesias I, Theyskens C, de Jong M, Gill B, Ahluwalia JS, de Zegher F, Dunger DB. Prevalence and determinants of hyperglycemia in very low birth weight infants: cohort analyses of the NIRTURE study. J Pediatr. 2010 Nov;157(5):715-9.e1-3 Beardsall K, Vanhaesebrouck S, Ogilvy-Stuart AL, Vanhole C, Palmer CR, van Weissenbruch M, Midgley P, Thompson M, Thio M, Cornette L, Ossuetta I, Iglesias I, Theyskens C, de Jong M, Ahluwalia JS, de Zegher F, Dunger DB. Early insulin therapy in very-low-birth-weight infants. N Engl J Med. 2008 Oct 30;359(18):1873-84 Beardsall K, Vanhaesebrouck S, Ogilvy-Stuart AL, Ahluwalia JS, Vanhole C, Palmer C, Midgley P, Thompson M, Cornette L, Weissenbruch M, Thio M, de Zegher F, Dunger D. A randomised controlled trial of early insulin therapy in very low birth weight infants, "NIRTURE" (neonatal insulin replacement therapy in Europe). BMC Pediatr. 2007 Aug 10;7:29 Contact: Di Picton
• Chief Investigator: Dr Malcolm Donaldson • Project Co-ordinator: Emma-Jane Gault Aim: To determine the impact on final height of oxandrolone and the timing of pubertal induction (12 vs. 14 yrs) in girls with TS receiving growth hormone treatment. Start date: November 1999 End date: 2011-2012 Trial status: 106 girls were recruited (between November 1999 and December 2003). The final height data collected this far have been analysed and demonstrate a clear benefit to final height of oxandrolone and of pubertal induction at 14 years of age. However these effects are not additive so there is no additional benefit from using oxandrolone and delaying pubertal induction (Gault et al., 2011. BMJ; 342:d1980). The final few patients continue to be followed-up until final height is reached, at which point the analysis will be updated. However, it is not anticipated that their addition will alter the outcome. Contact: Emma-Jane Gault MOCA: Metformin in Obese Children and Adolescents A multi-centre randomised placebo controlled trial of metformin in obese children and adolescents aged 8-18 years with insulin resistance and/or impaired glucose tolerance. • Principal investigator: Professor Peter Clayton • Project Co-ordinator: Dr Debbie Kendall Aim: To study the effects of metformin treatment compared to placebo at a dose of 1.5g per day for 6 months. Trial status: The trial is now closed to recruitment. Analysis is underway. Start date: May 2005 End date: July 2010 Contact: Debbie Kendall or Peter Clayton Links to other research resources for paediatric endocrinology and diabetes:
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