Plasma dimethylarginine & bile acids in T2D depressed & obese patients

• Research type

  Research Study

• Full title

  Variations in plasma dimethylarginine and bile acids in obese patients with type 2 diabetes and major depression

• IRAS ID

  251757

• Contact name

  Graham Mills

• Contact email

  graham.mills@port.ac.uk

• Sponsor organisation

  King's College Hospital NHS Foundation Trust

• Duration of Study in the UK

  0 years, 7 months, 1 days

• Research summary

  There is estimated to be around 346 million people worldwide with diabetes, with 90% of cases being classified as type 2 diabetes mellitus (T2DM). Associated obesity and major depression have pro-inflammatory effects in T2DM individuals, which can increase the progression of endothelial dysfunction leading to cardiovascular disease.

  The South London Diabetes Study (SOUL-D) provides a unique sample set for use in this study, as the samples have been collected at time of initial T2DM diagnosis before the instigation of dietary, lifestyle or pharmacological intervention. Therefore, there is reduced risk of these factors affecting the results of this particular study.

  Four cohorts of patient samples from the SOUL-D study sample set have been selected to test the hypothesis of whether plasma concentrations of dimethylarginines (ADMA and SDMA) and bile acids are linked to the prevalence of major depression, and if they are influenced by obesity in the T2DM patient (46 samples in each cohort, as per Power calculation):

  Not depressed, BMI<25
  Not depressed, BMI>30
  Depressed, BMI<25
  Depressed, BMI>30

  A novel mass spectrometry method will be developed and evaluated for the measurement of plasma dimethylarginines, and bile acids will be measured by a previously published method. Other biomarker results analysed previously on the samples will also be used in statistical analysis of the study data.

  From the study design, envisaged that the hypothesis can be tested to prove/disprove whether major depression and obesity have an effect on cardiovascular disease progression in T2DM subjects enrolled onto the SOUL-D study.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  18/EE/0393

• Date of REC Opinion

  21 Dec 2018

• REC opinion

  Further Information Favourable Opinion