The trial, which is called the Diabetes Remission Clinical Trial (DiRECT), builds on earlier work by co-lead investigator Prof. Roy Taylor, director of the Magnetic Resonance Centre at Newcastle University in the United Kingdom.
The earlier work showed that a radical change in diet can reverse type 2 diabetes.
The results of the trial, recently reported in The Lancet, suggest that remission of type 2 diabetes may be achievable through intensive weight management programs supported by routine primary care.
The team's findings revealed that after 12 months of radical weight management, participants lost an average of 10 kilograms (22 pounds), and that 45.6 percent of them went back to being non-diabetic without medication.
'Long-term maintenance of weight loss' focus
Prof. Taylor says that significant weight loss reduces the amount of fat in the liver and pancreas so that they can start working normally again.
"What we're seeing from DiRECT," he remarks, "is that losing weight isn't just linked to better management of type 2 diabetes: significant weight loss could actually result in lasting remission."
"Our findings suggest that even if you have had type 2 diabetes for 6 years," adds trial co-leader Prof. Michael Lean, chair of Human Nutrition at the University of Glasgow in the U.K., "putting the disease into remission is feasible."
He says that their approach differs from the conventional way of managing type 2 diabetes in that it focuses "on the need for long-term maintenance of weight loss through diet and exercise and encourage[s] flexibility to optimize individual results."
Diabetes is a global health problem
In type 2 diabetes, the body's cells do not react to insulin as they should, which is known as insulin resistance. The pancreas — an organ that produces insulin — tries to compensate by producing more insulin, but eventually it cannot make enough, and blood sugar levels go up.
High blood sugar, or hyperglycemia, damages many parts of the body and can lead to severe health problems, including heart disease, vision impairment, and kidney disease.
Of the hundreds of millions of people worldwide who have diabetes, the vast majority have type 2, which results largely from carrying too much weight and not being physically active.
In the United States, around 90–95 percent of the 30 million people with diabetes have type 2. And while it normally strikes people aged 45 and older, an increasing number of children and young adults are also developing type 2 diabetes.
Intensive weight management vs. usual care
The first-year results of DiRECT concern 298 people aged 20–65 years old who were recruited to the trial between July 2014 and August 2016, and who had been diagnosed with type 2 diabetes during the previous 6 years. They were attending 49 primary care or general practice (GP) clinics across Scotland and a region in North East England.
The trial randomly assigned the GP clinics to deliver one of two treatment types: either a radical weight management program called Counterweight Plus, or adherence to current best practice guidelines.
This resulted in 149 people following the intensive weight management program and a further 149 people following current practice (the controls).
During the first 3–5 months, the participants on weight management consumed a total diet replacement formula that gave them no more than 855 calories per day. After that, they gradually introduced normal food over 2–8 weeks.
Throughout the program, they received support for maintaining weight loss that included sessions of cognitive behavioral therapy together with advice on how to be more physically active. From the start of the program, they stopped taking drugs to control high blood pressure and diabetes.
Diabetes reversed in nearly half of subjects
By the end of the first year, nearly a quarter (36 of the 149) people on the weight management program had lost 15 kilograms (33.1 pounds). The average weight loss in this group was 10 kilograms (22.1 pounds) compared with only 1 kilogram (2.2 pounds) in the control group.
In addition, almost half (68 of 149) of the people on weight management had reversed their diabetes after 12 months, compared with only 4 percent (6 people) of the controls.
A significant result of the trial was the strong link between amount of weight loss and success in reversing diabetes.
Nearly all (9 out of 10) of those who lost 15 kilograms (33.1 pounds) or more managed to reverse their type 2 diabetes, compared with only three quarters (47 out of 64) of those who shed 10 kilograms (22.1 pounds) or more.
The weight management group also improved in other measures of health, including improvements in average levels of triglyceride, or blood lipid, and blood pressure. Nearly half of the group was able to stay off blood pressure drugs without their blood pressure going up.
DiRECT is following the participants for 4 years to establish the extent to which the weight loss and remission achievements persist.
As most of the participants were British and white, the researchers cannot say whether the findings apply to other groups, especially those who in whom type 2 diabetes can develop as a result of lower weight gain, such as people from South Asia.
Targets 'achievable for many people'
Prof. Taylor explains that the trial results suggest that it is not necessary to try to achieve the huge weight losses such as those "targeted by bariatric surgery" to reverse the mechanisms that cause type 2 diabetes.
The weight loss targets of the program followed in the study are "achievable for many people," he says, noting, "The big challenge is long-term avoidance of weight regain."
These results, together with those of other studies, "indicate that weight loss should be the primary goal in the treatment of type 2 diabetes," notes Professor Emeritus Matti Uusitupa, of the University of Eastern Finland, in an accompanying editorial.
Prof. Uusitupa also remarks that the evidence suggests that the best time to begin making lifestyle changes and working to reduce weight is when diabetes is diagnosed, "because motivation of a patient is usually high and can be enhanced by the professional healthcare providers."
"These findings are very exciting. They could revolutionize the way type 2 diabetes is treated."
Prof. Roy Taylor