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10% Weight Loss in Pre-Diabetes

Average 10% weight loss in 4 out of 5 people with pre-diabetes1

  • Cambridge Weight Plan is an evidence-based weight loss and maintenance programme with sustained health benefits
  • Flexible energy intake and flexible combinations of formula and regular food
  • Formula diets for primary and secondary care and community settings
  • Average 15% weight loss2 and 10% maintenance (1 year evidence) in obstructive sleep apnoea with sleep benefit
  • In secondary heart disease prevention average 10% weight loss4 and 7% weight maintenance (1 year evidence with aerobic interval training) and
  • Increased insulin sensitivity
  • Less atherogenic blood lipids
  • Small lean mass losses
  • Improved cardiovascular fitness
  • Predictable weight loss before bariatric surgery
  • Average 10% weight loss and maintenance (4 year evidence) in osteoarthritis with maintained symptom benefit11 and improved vitamin D status and maintained bone health
  • Weight loss and maintenance (1 year evidence) in psoriasis with maintained skin improvement
  • Reduced ‘pro-inflammatory’ and ‘pro-insulin resistance’ protein panels with weight loss, and one year maintenance of both reduced weight and improved proteomics markers

The International Diabetes Federation (IDF 2015) estimates that the global population of people known to have type 2 diabetes will rise from about 415 million in 2015 to 642 million in 2040. Much of the increase will occur in low and middle income countries where rising costs of medications will need to be carefully controlled. Reversal of early diabetes (<6 years since diagnosis) with an evidence-based low cost non-pharmacological and non-surgical intervention should prove helpful. Lim et al (2011) demonstrated reversal of early diabetes using a very low calorie diet and this has been shown by the same group to be sustainable for 6 months in 40% of subjects who achieved a fasting blood glucose of <7mmol/l at the end of the initial weight loss (Steven et al, 2016). Professor Roy Taylor, principal investigator in these studies believes that type 2 diabetes mellitus is potentially reversible in some individuals.

Based on this work and a translation into primary care pilot study reported by Professor Mike Lean of Glasgow University (Lean et al 2013) a study on diabetes remission by weight loss and maintenance in a primary care setting is now underway (Leslie et al 2016), supported by grants from Diabetes UK, provision of free product by Cambridge Weight Plan and a weight management programme from Counterweight Ltd.

Two hundred and ninety-eight participants (aged 20 to 65y, BMI >27 and <45, time since diagnosis up to 6 years) were randomised to either usual care or a 12 to 20 week low energy liquid diet (825-853kcal/d total diet replacement by Cambridge Weight Plan as soups, shakes and meal-replacement bars) followed by structured food re-introduction delivered within the Counterweight Plus programme. Usual care was continuation of usual diabetes and obesity management according to guidelines. Practices in Scotland and the Tyneside region of England participated. The protocol included a relapse management option to address weight regain or diabetes recurrence with options to use partial or total diet replacement with liquid formula for short periods followed by food reintroduction. Participants were to be followed for two years but this has now been extended following receipt of a grant extension from Diabetes UK. The primary endpoints were body weight and reversal of diabetes (targets> 15kg, HbA1c < 48 mmol/l). The one year results were presented at the International Diabetes Federation meeting in December 2017 and published in the Lancet (Lean etal 2017).

Weight loss of 15kg or more at 12 months was achieved by 36 participants (24%) in the intervention group but none in the control group (P<0.0001). Diabetes remission was achieved by 68 participants (46%) in the intervention group and six (4%) in the control group (p<0.0001). However 86% of participants (31 of 36) who lost 15kg or more achieved diabetes remission, while 73% who lost more than 10kg (47 of 64) achieved remission (See Figure).

Secondary endpoints included quality of life (measured by EuroQol 5 Dimensions visual analogue scale) which improved by 7.2 points in the intervention group and decreased by 2.9 in the control group (p=0.0012). The number of prescribed antidiabetic and antihypertensive medications was significantly reduced in the intervention group (baseline mean 1.1 reduced to 0.4 at 12 months for antidiabetic medications) compared to the control where little reduction was seen (P<0.0001).

This important clinical trial continues and will provide additional information about the role of the rescue packages and efficacy of the long term weight maintenance programme. Achieving relatively large weight losses of 10 to 15kg with total diet replacement formula diet is clearly critical in achieving diabetes remission, as are the carefully managed stepped food reintroduction and managed weight maintenance. Total Diet replacement programmes work by causing a larger energy deficit than occurs with conventional reducing diets thereby delivering rates of weight loss of 1 to 1.5kg/week in women and a little more in men. Lean mass losses have been shown to be relatively low in most trials (see overleaf for references) and return to baseline weight does not occur if effective maintenance programmes are put in place. Product composition conforms to EU regulations ensuring sufficient high-class protein, essential fatty acids and micronutrients.

DiRECT showed that with an average 10kg weight loss at 12 months using an initial total diet replacement programme used within a Counterweight-Plus programme in a primary care setting, almost half of participants achieved remission.

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