Elastase in diabetes study v1.0

• Research type

  Research Study

• Full title

  The measurement of faecal elastase to investigate exocrine pancreatic insufficiency in type 1 diabetic patients.

• IRAS ID

  197850

• Contact name

  Gemma Reidy

• Contact email

  gemma.reidy@uhcw.nhs.uk

• Sponsor organisation

  UHCW NHS Trust

• Duration of Study in the UK

  0 years, 3 months, 2 days

• Research summary

  Elastase is produced by the pancreas and is required for the digestion of fat in the gut. A lack of this enzyme results in malnutrition, fatty stools, gastrointestinal (GI) symptoms and wasting. As the enzyme passes through the intestines, it is not degraded so it can be measured in faeces. It has been reported that there may be an increased incidence of insufficiency in diabetic patients, leading to the problems mentioned previously as well as increased difficulty in maintaining their blood glucose levels. Therefore measurement of faecal elastase in these patients may be indicated.
  
  This project will include a full method evaluation of a faecal elastase assay that can be performed at the UHCW laboratory. Through the diabetes clinics, type 1 insulin dependent diabetics will be recruited, and their faecal elastase measured. Project information will be posted prior to their usual appointment, and if they wish to participate they can consent during the appointment. A stool collection device and questionnaire will then be given out in the clinic, to be completed at home and returned by post to the laboratory. On arrival the stool samples will be stored at -20oC and analysed in batches. Results regarded as a low level of faecal elastase (<200ug/g) will be returned to the patient's diabetes consultant for follow up.

  The data collected from the elastase measurement and questionnaires will be collated and any statistical trends will be identified. This information will then be discussed with the diabetes teams to decide if routine faecal elastase testing of particular patients is warranted.

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  16/LO/0661

• Date of REC Opinion

  19 Apr 2016

• REC opinion

  Further Information Favourable Opinion