NOVA-GH Study

• Research type

  Research Study

• Full title

  Using Novel Assays for the Evaluation of Gut Hormone Profiles in Health and Disease (NOVA-GH)

• IRAS ID

  318120

• Contact name

  Tricia Tan

• Contact email

  t.tan@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Duration of Study in the UK

  7 years, 0 months, 3 days

• Research summary

  Hormones secreted by the gut (gut hormones) are integral to signal satiety and energy status from the gut to the brain, to control food intake. Important gut hormones such as peptide YY, glucagon-like peptide-1 and oxyntomodulin work together to reduce appetite and calorific intake.

  Gut hormone levels are affected by disease states and gastrointestinal disorders. Alterations in gut hormone profiles in these conditions have not been fully characterised.

  Complicating the situation, most studies to date use older techniques (or assays) including radioimmunoassays, to measure gut hormones. These are non-specific and cannot always distinguish active forms of hormones from inactive ones, or one fragment from another. They are difficult to standardise, making it difficult to compare data between different studies. This study uses a newer type of assay that involves mass spectrometry. This gives greater accuracy and specificity allowing us to differentiate hormone fragments from one another.

  DESIGN: Observational case-control study

  AIMS: To accurately measure gut hormone profiles in the fasting state and in response to a standard meal

  OUTCOME MEASURES: Gut hormone profiles and characterisation of metabolomic changes in the blood (changes in the profile of other small biological molecules and chemicals also known as metabolites).

  POPULATION: This study plans to recruit 120 participants from different patient subgroups (total: 1680):

  -Lean-healthy
  -Overweight-healthy
  -Obese-healthy
  -Type 1 diabetes
  -Type 2 diabetes
  -Inflammatory bowel disease
  -Coeliac disease
  -Previous upper GI surgery
  -Previous lower GI surgery
  -Upper GI malignancy
  -Lower GI malignancy
  -Non-alcoholic fatty liver disease
  -Pancreatic disease
  -Other undefined medical and gastrointestinal conditions

  DURATION: Up to 2 visits. One 1-hour Screening Visit and a Study Visit up to 5 hours

  Data and metabolomics from this study will generate widely used clinical reference ranges which could allow us to better diagnose related conditions in patients and provide opportunities to develop new therapeutic options in the future.

• REC name

  London - Surrey Research Ethics Committee

• REC reference

  24/PR/0078

• Date of REC Opinion

  12 Mar 2024

• REC opinion

  Favourable Opinion