TDMR Europe at the European Association for the Study of Diabetes (EASD) 2018 Annual Meeting
Posted On: 9th October 2018
TDMR Europe at the European Association for the Study of Diabetes (EASD) 2018 Annual Meeting
Last week (1-5th October), Berlin hosted one of the biggest international conferences related to the study of diabetes held by the European Association for the Study of Diabetes (EASD) which gathers annually 15,000 delegates from over 130 countries.
At the conference, the members of the PREVIEW research team presented results on weight maintenance over three years in over two thousand overweight people with pre-diabetes who begin their risk-reduction with an 800kcal/d total diet replacement (TDR) diet given with a behaviour change intervention.
A ‘soups and shakes’ total diet replacement TDR (800kcal/d) diet was used as the initial intervention to achieve weight loss in people with pre-diabetes based in eight centres around the globe*. The initial weight loss was intended to prepare subjects prior to a three-year weight maintenance and lifestyle intervention intended to prevent diabetes.
Of 2224 (of whom 1504 were women) participants who were overweight (BMI >25 kg/m2) with pre-diabetes (according to ADA** criteria) who commenced the dietary programme the overall mean weight loss after 8 weeks was 10.7 + 0.4kg (10.8% of body weight). After eight weeks women lost 10.2kg and men 11.8kg body weight on average, of which 3.2kg (31%) and 1.9kg (16%) were fat free mass respectively (FFM).
First author, Dr Pia Christensen, a postdoctoral fellow and dietitian at the University of Copenhagen, Faculty of Science, who has over ten years’ experience of using formula diets said ‘When I started work with formula diets I, like most of my dietetic colleagues, did not believe that this type of diet could be so effective nor that weight could be maintained afterwards’. She added ‘We showed that compliance with this type of programme is very good (only a small proportion of participants dropped out) probably because the fast weight loss makes the participant feel better very quickly and they want to stay in the programme.’
After 8 weeks 35% of participants were no longer ‘pre-diabetic’ but among those with slightly higher baseline blood glucose levels (using WHO criteria***) and who achieved a ‘successful’ weight loss of 8% or more, nearly two-thirds were no longer ‘pre-diabetic’.
Systolic blood pressure was ‘normalised’ in women, down 7 mmHg from 127mmHg and nearly normalised in men, down 8mmHg from 133mmHg. Blood lipid profiles were largely improved, fasting blood glucose and insulin were reduced, and insulin sensitivity was significantly improved. Metabolic syndrome was less severe in the group as a whole after 8 weeks LED diet.
Adverse events were reported in detail, 7.6% of participants complained of constipation despite the advice to avoid this from the beginning by using bulk laxatives, 2.0% complained of dizziness and no cases of gout occurred in any of the women, but six cases in men. Establishing meaningful rates for low-frequency adverse events requires that large subject numbers be studied, and this data-set enables meaningful rates to be quoted.
After the initial weight loss period those who achieved 8% weight loss were entered into a randomised trial of higher and lower dietary protein intake, higher and lower dietary glycaemic index levels and higher and lower physical exercise activity intensity levels for three years. The results of the three-year maintenance outcomes presented at the European Diabetes meeting (EASD) in Berlin on 5th October 2018 showed that both diets and both exercise strategies were equally effective for weight-loss maintenance and most participants were able to sustain ≥8% weight loss at 3 years. Indeed, the PREVIEW intervention was so effective that there were too few cases of type 2 diabetes to distinguish between the diets.
The PREVIEW team also showed that having a higher initial BMI, a higher income, being less discouraged to eat healthily by family members and being male were linked to greater weight loss.
Commenting on the results Professor Anthony Leeds, chairman of TDMR Europe said ‘This large observational study of Total Diet Replacement diet (800kcal/d) shows for the first time, in a global context, that this is a safe, effective way to begin diabetes prevention programmes. Compliance was high (90%) and the average weight losses of >10% were close to the American endocrinologists’ 10% weight loss targets for diabetes prevention. Metabolic and blood pressure changes were good as expected, and adverse event rates were low. Taken in conjunction with other published clinical trials showing weight maintenance after TDR for up to four years, these results are a substantial offering in the global fight against the tsunami of diabetes that will shortly overwhelm health care providers.’
* The centres were located in Denmark, Finland, The Netherlands, Spain, Bulgaria, the United Kingdom, Australia and New Zealand.
Criteria for impaired fasting glucose:
*American Diabetes Association (ADA): fasting plasma glucose from 5.6 to 6.9 mmol/l
**World Health Organisation criterion: fasting plasma glucose from 6.1 to 6.9 mmol/l
References: