A Landmark Study for Management of Type 2 Diabetes: DiRECT

TV programmes around diet and Type 2 Diabetes seem to have become almost as common as celebrity cooking programmes, US police dramas and talent contests. Since the publication of the DiRECT (Diabetes in Remission Clinical Trial) in the Lancet in December 2017, interest in remission of Type 2 Diabetes has ranged from people with the condition to health care professionals and of course public health planners. Let’s look at the background to the ground breaking DiRECT study and where things currently stand around the management of this increasingly common but devastating clinical problem.

Media Messaging

‘Diabetes is CRIPPLING the NHS’

‘Management of Type 2 Diabetes Now Accounts for 10% of the TOTAL UK Health Care Budget’

‘Every year the UK NHS spends ten BILLION pounds on diabetes’

These attention grabbing headlines appear regularly in our social, print, radio and television media outlets. While alarming, these messages reflects the continued increase in the number of people developing Type 2 Diabetes, with overweight and obesity the key driver, and the clear implications for health and NHS resource.

In keeping with snappy media messaging let see if we can change the headlines?

The Start of the Sea Change?

‘Remission’ of Type 2 Diabetes following successful bariatric surgery has been reported for many years 1 Since then Type 2 Diabetes has been shown to be a reversible metabolic condition 2, 3  Work by Roy Taylor and colleagues at the University of Newcastle has shown that, contrary to the commonly held view that at time of diagnosis around 50% of beta cells (cells within the pancreas which produce insulin) have been damaged beyond repair, these cells can return to function following loss of fat in the pancreas and liver4 resulting from substantial weight loss of up to 3 stones.

Great news, particularly for people recently diagnosed with Type 2 Diabetes: within 10 years of Type 2 Diabetes diagnosis, about two-thirds of individuals can return to non-diabetic levels of blood glucose control after diet-induced weight loss averaging 15 kg. This also meaning no need for diabetic medications: a key motivation for many people. These results were exciting but only observed in a small number of motivated volunteers attending a specialist research unit. The practical implications for routine clinical practice around remission of Type 2 Diabetes was then tested in the DiRECT randomised controlled trial.

DiRECT

Funded by Diabetes UK, this study compared outcomes of two groups of participants. The control group continued with best practice according to current guidelines. The intervention having an additional intensive weight management programme, Counterweight-Plus, in addition to usual best practice care. The primary outcomes for the study were numbers achieving remission of Type 2 Diabetes (HbA1c <48mmol/mol off diabetes medication for at least 2 months) and weight loss of 15kg both at 12 months.

All participants were seen at their GP practice and the weight management intervention was delivered either by a dietitian or practice nurse.

The programme, Counterweight-Plus, was developed by a team of obesity specialist dietitians through funding from the Scottish Government Health Department: the initial work starting in 2010. After long hours, lots of constructive debate across broad spectrum of health care professionals and patients coupled with the usual blood sweat and tears, the programme was tested in 92 individuals across Scotland with outcomes published in 20135.

Counterweight-Plus consists of an initial phase of nutritionally replete soups and shakes which provide just over 800kcal per day. This approach allows a step away from usual food and behaviours, will achieve substantial weight loss with compliance and allows the participant to start thinking about what their new healthier lifestyle should involve. Importantly, the soup and shakes phase is followed by a structured process of gradual food introduction and then pro-active weight loss maintenance. Key behavioural strategies including self-monitoring, problem solving, action planning, goal setting, stress management and emotional control training underpin each phase of the programme: in other words it’s not all about the shakes and we need to be very clear on this!

Equally important is to set longer term expectations from the outset: a new lower body weight needs new lifestyle behaviours.

Results of DiRECT

The next piece of great news for people with Type 2 Diabetes was the key finding in the DiRECT study where almost half (46%) of the group receiving the weight management programme achieved remission at 12months6. Remember remission also means the individual no longer needs medications to manage their blood sugar levels: huge motivator. Of note was a remission rate of 9 out of 10 for those who lost 15kg or more and of 7 out of 10 for those who lost 10kg or more. In ‘old money’ 10-15kg is around  1½ -2½ stones. Typical lifestyle based programmes general achieve up to 10-12lbs weight loss so a more intensive programme is required.

What Now?

First of all in keeping with all scientific studies the next step for DiRECT are the 2 year outcomes. These are due out later this year and will then be followed by outcomes for 3+ years. However the narrative around management of type 2 diabetes is already changing with more and more emphasis on the fact that this does not necessarily need to be a chronic progressive disease. Substantial weight loss of the magnitude of 10-15kg has been confirmed as being associated with remission of this damaging disease.

In summary, take home message for people with type 2 diabetes, health care staff and planners should be a change in media headlines along the lines of ‘working together to beat type 2 diabetes into remission’.

References

  1. Dixon JB, O’Brien PE, Playfair J, et al. Adjustable gastric banding andconventional therapy for type 2 diabetes: a randomised controlled trial. JAMA 2008; 299(3): 316–323.
  2. Lim EL, Hollingsworth KG, Aribisala BS, Chen MJ, Mathers JC, Taylor R. Reversal of type 2 diabetes: normalisation of beta cell function in association with decreased pancreas and liver triacylglycerol. Diabetologia 2011; 54: 2506–14.
  3. Steven S, Hollingsworth KG, Al-Mrabeh A, et al. Very Low calorie diet and 6 months of weight stability in type 2 diabetes:pathophysiological changes in responders and nonresponders.Diabetes Care 2016; 39: 158–65.
  4. Steven S, Hollingsworth KG, Small P, et al. Weight loss decreases excess pancreatic triacylglycerol specifically in type 2 diabetes. Diabetes Care 2016; 39: 158–65.
  5. Lean M, Brosnahan N, McLoone P, et al. Feasibility and indicative results from a 12-month low-energy liquid diet treatment and maintenance programme for severe obesity. Br J Gen Pract 2013;63: e115–124.
  6. Lean MEJ, Leslie WS, Barnes AC, Brosnhan N, Thom G, McCombie L, et al. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open label, cluster randomised trial. Lancet. 2017 Dec 4. pii: S0140-6736(17)33102-1. doi: 10.1016/S0140-6736(17)33102-1.

Louise McCombie BDALouise McCombie

@louise_mccombie

Research Associate (Dietitian), Diabetes Remission Clinical Trial (DiRECT), University of Glasgow

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