Diabetes Remission Clinical Trial

This site contains information about the Diabetes Remission Clinical Trial

Trial Description

DiRECT is a research study investigating whether offering an intensive programme for weight loss and weight loss maintenance would be advantageous for people with Type 2 diabetes. Specifically, this programme aims to increase the number of people who can become non-diabetic. Participants are recruited only via NHS General Practices which are taking part in the study, and individuals cannot be accepted in DiRECT. General Practices are randomly allocated to offer their patients one of two treatments. Each treatment has already been shown to be effective, and the question of DiRECT is whether one is better than the other. All participants will be followed for at least 2 years, to see how many remain diabetic under each treatment, and how that relates to their weight. Some participants will also undergo detailed tests concerning the amount of fat in their liver and pancreas.

DiRECT is being conducted in NHS practices in Scotland and in Tyneside, and it is the largest research study, to date, ever supported by the charity Diabetes UK. Additional support in kind is provided by Cambridge Weight Plan. The NHS “sponsor” is NHS Greater Glasgow and Clyde.

Trial Status

Recruitment Status: CLOSED

Funder: Diabetes UK

Primary Sponsor: NHS Greater Glasgow and Clyde(UK)

Recruitment countires: United Kingdom

Health condition studied: Type 2 Diabetes Nutritional, Metabolic, Endocrine

Target Sample size: 280

URL: World Health Organization webpage

URL: NHS DiRECT webpage

Study Protocol DiRECT Protocol

Last updated: Wednesday 3rd August 2016

What is diabetes?

There are several types of diabetes. All are metabolic disorders which can result in progressive damage to the main organs in the body. Diabetes especially damages the heart, brain, feet and legs, eyes, kidneys and nerves. There are two main types of diabetes: Type 1 (caused by an immune attack destroying the pancreas cells which make insulin), and Type 2 (caused by being overweight and resistant to the effect of insulin, with gradual loss of ability to make enough insulin). DiRECT is researching the treatment of Type 2 diabetes, which is the most common type, and the most expensive for health services.

Why is DiRECT important?

Some people with Type 2 diabetes can become non-diabetic again, at least for a period. That is called a remission of diabetes. A remission of diabetes will allow the patient to stop taking anti-diabetic drugs. This is important as the drugs are inconvenient and can cause side-effects. Also these drugs cost the NHS around £800million per year. If diabetes remission is long term this would prevent or delay the long-term damage which diabetes causes in different body-organs. The mechanisms underlying the return of normal glucose control will also be examined in the Tyneside cohort. Detailed tests using magnetic resonance scans and insulin secretion tests will be carried out.
A new treatment programme which helps to produce remissions in type 2 diabetes could therefore be advantageous for people with diabetes, and also save treatment costs. For people who achieve a long term remission, the effect upon their future health and well being could be very great indeed.