DIB-NET Study
Research type
Research Study
Full title
Longitudinal observation study and investigation of the effects of diet on the measurement of routine biomarkers in patients with gastro-entero-pancreatic neuroendocrine tumours (NET).
IRAS ID
197653
Contact name
Martin O Weickert
Contact email
Sponsor organisation
UHCW NHS Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The Arden Neuroendocrine Tumour (NET) Centre in University Hospitals Coventry & Warwickshire (UHCW) NHS Trust is one of the eight European Neuroendocrine Tumour Society (ENETS) Centres of Excellence (CoE) in the UK. NET related research is an integral part of the CoE status. The Chief investigator and Lead of the Arden NET Centre in UHCW, Dr Martin O Weickert, has extensive experience in the design, performance and publication of high impact nutrition and metabolic research. The main objective of the here proposed studies is to investigate the effect of diet and nutrition on routinely used biomarkers diagnostic and therapeutic aspects in patients with NET.
As part of routine care, patients with NET are asked to provide a blood sample every 6-12 months for routine clinical tests, according to guidelines. The Main main study (A) is a prospective observational study where we will ask consented patients with NET to provide an additional 10 mL blood sample at the same routine clinical appointments every 6-12 months. These samples will be stored for future use in NET related biomarker research, i.e. longitudinal assessment of NET biomarkers in the same assay (to reduce inter-assay covariation) and comparison of novel NET biomarkers with routinely established markersthis research project.
The study also comprises 2 sub studies:
• Study B: Nutritional Breakfast Study - 25-35 NET patients and 10-15 control participants (non-NET) are asked to attend 3 morning visits in the metabolic unit, after 10-h overnight fasts; after insertion of an IV cannula; breakfast and beverages will be consumed directly or delayed for 180 min, and blood sampling (total 35 mL per visit) will be performed via the IV cannula every 30 min for 180 min, to assess the impact of food consumption on routinely measured NET biomarkers in blood.
• Study C: GLP-1 Patients Blood Sample collection: 10 – 15 patients recruited from PCOS, Diabetes or Obesity Clinics who routinely receive GLP-1 injections for clinical reasons, to provide 35mls of blood at baseline and over 180 min in timed intervals every 30 min; to assess whether an increase in GLP-1 (which is also known to markedly increase after food intake) affects biomarkers that are routinely measured in NET patients.REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0466
Date of REC Opinion
14 Dec 2016
REC opinion
Further Information Favourable Opinion