Within 12 months, almost half the participants were no longer diabetic and had been able to cease antidiabetic medication, and in many cases blood pressure-lowering drugs too, found researchers led by the Universities of Newcastle and Glasgow.
After 1 year, just under a quarter of the subjects had lost 15 kilograms (kg) or more, while around half maintained a weight loss exceeding 10 kg. Remission was achieved in 86% of participants who lost 15 kg, while 73% of subjects losing at least 10 kg also reversed their diabetes.
The weight management program was delivered by routine primary care staff and did not require specialist treatment.
“This is a watershed moment for T2D understanding and management. It can be reversed to normal by substantial weight loss,” commented co-lead researcher Professor Roy Taylor of the University of Newcastle.
“It is a watershed in understanding the underlying cause of type 2 diabetes [which is] too much fat inside liver and pancreas,” he continued.
The paradigm shift that ‘diabetes need not be for life’ was echoed by Professor Michael Lean from the University of Glasgow, who also co-led the research.
“Our findings confirm that type 2 diabetes of up to 6 years' duration is not necessarily a permanent, lifelong condition. Weight loss sufficient to achieve remission can be attained in many individuals by use of an evidence-based structured weight management programme delivered in a non-specialist community setting by routine primary care staff,” he wrote.
Public Health significance
The potential healthcare cost savings that could be achieved by rolling out the program on a nationwide basis are enormous.
“One estimate put the overall cost at £14 billion per year. Our findings could potentially save a substantial proportion of this,” suggested Taylor.
“As prescription of tablets to control blood sugar cost over £1 billion annually in the UK, and as the number of blood pressure tablets required in halved on this programme the potential savings are great. But the greatest savings will come in the form of less blindness, less amputation and less kidney failure.
“Many people will have had T2D for a long time, so not all can be reversed to normal, but savings of up to £1 billion annually in the long term are feasible,” he added.
The Diabetes Remission Clinical Trial (DiRECT), was an open-label, cluster-randomised study. It included 298 patients who had been diagnosed with T2D within the previous 6 years. The subjects ranged from 20-65 years and had initial body-mass index (BMI) ranging from 27-45 kg/m2.
The subjects were randomised into two groups, those who undertook the Counterweight Plus program and controls those who received best practice care.
The intervention group received a very low calorie formula diet (around 850 calories per day) for between 3 and 5 months, followed by a 2-8 week food reintroduction regime.
The participants ceased antidiabetic and blood-pressure lowering medication on day 1 of the trial.
Target outcomes were the achievement glycated haemoglobin A1c (HbA1c) level of less than 6.5% at 12 months (defined as T2D remission), and weight loss of at least 15kg.
Impact on T2D patients?
For patients with T2D, the findings of this study have life-changing implications.
“The first step in managing type 2 diabetes on diagnosis must now be to explain to the individual that they have a choice – a lifetime with diabetes and complications or substantial weight loss and long term avoidance of weight regain. Drugs should no longer be first line,” said Taylor.
Unlike in previous studies designed to combat diabetes, the emphasis was placed on cutting calorie intake, rather than on additional exercise. Although physical activity is important longer-term, too much exercise initially can lead to patients eating more to compensate; -making achievement of sustainable weight loss more difficult. Sustainability is critical to success, according to the researchers.
“It is really important to emphasise that substantial weight loss can only be achieved by decreasing food intake, and that additional exercise should be avoided during weight loss. This is because of compensatory eating (partly conscious and partly unconscious),” explained Taylor.
“What support is most effective in helping people avoid weight regain? That is a really important question because sustainability is vital.”
“This [study] is really just the start,” Taylor continued.
Raising awareness of the findings, and how they could change lives, are important next steps.
“Spreading the news by every means possible that T2D is a potentially reversible condition. Involving Primary Care doctors in the UK is a particular focus for us. Hopefully it will be discussed by national diabetes organisations round the world,” he said.
From a scientific perspective, “We need to know much more about the insulin producing cells (beta cells) and their de-differentiation. Now the simplicity of type 2 diabetes has been revealed, this will focus future basic science work.
“Ongoing research will answer the questions of whether diabetes stays away long term, and a formal health economic analysis will determine the cost savings,” Taylor added.
However, the real long-term solution to the global obesity and diabetes pandemic is to eat less, suggested Taylor in conclusion.
“The major barrier is political will in opposing the wishes of the food industry. To make an impact upon the enormous pressure on people to eat and to eat frequently will be difficult must be tackled to deal with the underlying problem.”
Source: The Lancet
Published online: 5 December 2017. DOI: 10.1016/S0140-6736(17)33102-1
“Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial”
Authors: Michael EJ Lean, Roy Taylor et al.