The OCEANIC Study
Research type
Research Study
Full title
One-stop sCrEening ANd Intensified Care (OCEANIC): a proof of principle randomised, controlled trial of intensive multifactorial intervention in early diabetic peripheral neuropathy
IRAS ID
325956
Contact name
Solomon Tesfaye
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
The aim of this study is to find out if nerve damage in people with type 2 diabetes can be reversed by managing risk factors more intensively. About half of people with type 2 diabetes develop nerve damage resulting in loss of sensation in the feet and legs. This increases the risk of injury leading to foot ulceration. Unfortunately, if foot ulcers get worse this can result in toe or leg amputation. One in four people with nerve damage can also suffer with distressing pain in the feet which responds poorly to treatment. Studies have shown that poor sugar control, high blood pressure, high cholesterol and increasing weight contribute to nerve damage in diabetes. We also know that nerve damage can be prevented or stopped in people with type 1 diabetes with good blood sugar control. However, similar evidence is lacking in type 2 diabetes. There is therefore a clear need to examine if a more intensive multi-factorial risk reduction approach aiming to support patients to achieve satisfactory individual target risk factor levels, will reverse or halt early nerve damage in people suffering from Type 2 diabetes.
Around half of all people with nerve damage will have early disease that might be reversed by intensified risk-factor reduction. It may therefore be important to screen for early nerve damage using modern point-of-care devices, that would otherwise be missed if clinical examination alone is used. Indeed, these point-of-care devices are utilized in our award winning One-Stop Screening Service delivered both in hospital and the community, where people with diabetes also have all nine annual health checks carried out. However, before the "One-Stop" clinic is widely adopted in the UK, evidence showing the reversibility of early nerve damage by an intensive risk-factor reduction is required and this study seeks to investigate this.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
23/NW/0301
Date of REC Opinion
13 Oct 2023
REC opinion
Further Information Favourable Opinion