The SOUL-D long-term follow-up study
Research type
Research Study
Full title
The South London Diabetes (SOUL-D) long-term follow-up study
IRAS ID
223971
Contact name
Khalida Ismail
Contact email
Sponsor organisation
King's College Hospital NHS Foundation Trust
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
Depression affects 20% of people with type 2 diabetes (T2D) and predicts increased risk of dementia, diabetes complications and premature death. However, the reasons for this are poorly understood. In the South London Diabetes (SOUL-D) study of 1735 people with newly diagnosed T2D, we demonstrated that people with depression had higher levels of inflammation, as measured using blood tests, than those without depression. This suggests that inflammation may provide a common link between depression and T2D, and moreover could be a target for potential treatments.
The SOUL-D follow-up study, proposed here, will test whether inflammation leads to both long-term worsening in depressive symptoms and to adverse diabetes outcomes. For the first sub-study, 400 people from SOUL-D will be randomly selected for repeat assessment 6-10 years after they were first recruited. These 400 people will be reviewed once in their GP surgery and undergo brief mental health questionnaires, cognitive testing, brief medical history, brief physical examination, blood tests and productivity measures, totalling around 90 minutes. In addition, all 1735 people will be followed up from their medical records to obtain data on subsequent depression diagnoses, treatments, mortality, blood sugar control and complications. The main analysis will test whether elevated inflammation at diagnosis of T2D is associated with worsening depressive symptoms over time. The secondary analysis will test whether elevated levels of inflammation is associated with poor diabetes outcomes, including cognitive decline, complications and death.
If successful, the SOUL-D follow-up study will provide support for the use of anti-inflammatory treatments to improve depression and subsequent outcomes in the growing population with depression and T2D.
REC name
East of England - Essex Research Ethics Committee
REC reference
17/EE/0272
Date of REC Opinion
9 Aug 2017
REC opinion
Further Information Favourable Opinion