Experts demonstrate total diet replacement is cost-effective solution for obesity and type 2 diabetes

Posted On: 17th January 2024

The increasing levels of obesity and comorbidities such as type 2 diabetes (T2DM) in Europe threaten to overwhelm the capacity of public health sector to address these challenges. In this context, it is more important than ever for slimming food businesses to join forces to help policy makers gain a better understanding of the role of their products in helping people with overweight and obesity lose weight and improve their health.

The DiRECT trial provides a clear example of how total diet replacement (TDR) can help reduce obesity and T2DM levels cost-effectively. In this study, almost half of those (46%) who went on a low-calorie diet with TDR achieved remission of their T2DM after one year and 36% at two years. A quarter of participants achieved a 15kg or more weight loss, and of these, 86% put their T2DM into remission. Interviewed by TDMR Europe Chair, Professor Anthony Leeds, Professor Mike Lean who led the DiRECT trial together with Professor Roy Talyor, explained the results of the study on EAWAZ TV, stressing that “participants lost 15-20 kg in about eight or 10 weeks…eight or nine out of 10 were no longer diabetic in that short time”.

To provide a better understanding of the longer-term benefits of the programme, DiRECT was extended for a further three years. In the extension study, 95 participants from the original DiRECT intervention group continued to receive support and advice from their GP surgery to help them maintain weight loss and those who regained more that 2kg during the three years continued the TDR diet. Data available from 85 participants of the original intervention group revealed an average 5-year weight loss of 6.1kg. Furthermore, 48 people from the intervention group were in remission at the start of the three-year extension study, while 11 of these (23%) were still in remission at five years, and their average weight loss was 8.9kg. The importance of these findings become even more clear by the fact that no trial using medication to treat T2DM in people with obesity has achieved similar results.

Discussing the issue of medication for T2DM, Prof Lean said “we have seen patients who have taken insulin or powerful glucose-lowering drugs but then they have a lot of side effects; they risk hypoglycaemia and indeed mortality is increased in people who pursue normal glycemia by the conventional medications”.

According to Prof Lean, in the DiRECT study the participants saw a dramatic fall in their blood pressure. “That can be quite alarming for patients who are on blood pressure medication” Prof Lean said. He explained that “overall in DiRECT in that period on the formula diet there was a drop in blood pressure of 10 millimetres of mercury on average. So, half the patients lost more than that in blood pressure. That’s a very big fall in blood pressure and that is why we also elected to ask our patients to stop taking their anti-hypertensive and diabetic medications on day one”. Prof Lean added “we told them that because we knew that was likely to be a case that losing weight if they followed our diet programme was more effective than the drugs they were taking. Now that is true for those who followed the programme carefully and actually did lose all that weight”.

Secondary analyses from the original two-year DiRECT trial have shown cardiometabolic improvements, including cardiorespiratory fitness as well as lower cardiovascular risk. Moreover, in DiRECT, serious adverse events were 54% less common at five years in those randomized to weight loss. Contributing to this were fewer bacterial infections, strokes, and notably fewer cancers.

Also, among the benefits of using slimming foods to tackle obesity and improve T2DM is the possibility of long-term use of these products as opposed to antidiabetic medication, such as, semaglutide, which, as the National Institute for Health and Care Excellence (NICE) has recommended, can only be used for a maximum of two years.

Prof Lean also presented the economic analysis of the results of the DiRECT trial. The researchers analysed all the medical costs during the first two years of the study, including hospital admissions for serious and minor problems, physiotherapies as well as attending general practitioners for infections and colds. “All those things we costed up and what we found was the medical care costs of people who went through this weight management programme were substantially less than the people who didn’t, and part of that was the cost of the drugs of course, because diabetes drugs nowadays and anti-hypertensive drugs are quite expensive, and we were able to stop nearly all of them after two years”. Prof Lean said. “Part of it was also patients who went through the programme had less serious adverse events they ended up in hospital less often. And so, we’re beginning already to see clinical benefit from substantial weight loss” he added.

The cost-effectiveness of using TDR for weight loss in people with obesity and overweight has been demonstrated by previous studies such as the DROPLET trial. The DROPLET research showed that delivery of TDR and subsequent weight maintenance was feasible and cost-effective in a primary care setting, and that some weight loss was maintained in some participants for up to three years.

The full interview with Prof Lean is available here.

More information on the use of TDR for weight loss and diabetes remission and prevention is available here.

A list of studies in which weight loss was achieved with TDR can be found here.

TDMR Europe works to help stakeholders develop a better understanding of formula diet foods and aims to increase awareness of the scientific evidence showing the effectiveness of these products in tackling obesity and improving related comorbidities. Find out more here.

Aris Myriskos

TDMR Europe Secretariat