How low should we go?

Transcription

1 How low should we go? Feedback from DiRECT: using low calorie diets with Type 2 Diabetes Alison Barnes Research Associate (Newcastle University) Diabetes Dietitian (Newcastle Hospitals NHS Trust) Diabetes UK Clinical Champion alison.barnes@ncl.ac.uk

2 Feedback from DiRECT How did we get here? Where are we now? Where s it all heading?

3 A junk shop find ahead of its time?

4 T2DM: A Lifelong Condition? Inevitable decline in beta cell function & progression towards insulin therapy Prospective Diabetes Study Group UK (1995) Diabetes 44:

5 Bariatric Surgery and T2DM remission Demonstrated that remission of type 2 diabetes is possible Remission 27-97% Significantly better outcomes than lifestyle/medication comparison groups Factors associated with greater likelihood of remission Improvements seen even before significant weight loss

6 Low Calorie Diets and T2DM DUK-funded Counterpoint study 8 week 600kcal liquid diet (plus veg) reversed T2DM in 73% (n=15) 15kg weight loss required Reduced fat in liver and pancreas Proof of Concept Lim et al. Diabetologia 2011; 54:

7 Proposed mechanism for T2DM/Reversal: the Twin Cycles Increased basal insulin Increased demand for insulin Fat increases liver insulin resistance LIVER Elevated insulin levels PANCREAS Increased pancreas fat Increased Liver Fat Fat from liver blunted insulin response to meals Taylor. Diabetologia 2008; 51: 1781

8 Reversal of metabolic abnormalities: liver Blood glucose Liver glucose production liver insulin resistance Liver fat content liver fat Liver cycle Lim et al. Diabetologia 2011; 54:

9 Reversal of metabolic abnormalities: pancreas 12 Pancreas TG content First phase insulin response Week Week acute insulin response to food Pancreas cycle islet fat Lim et al. Diabetologia 2011; 54:

10 Pancreas fat reduction: specific to T2DM Steven et al Diabetes Care 2015 Steven et al Diabetes Care 2015

11 Weight loss strategies More Gold standard intensive lifestyle NHS/commercial 30-40% weight programmes loss needed programmes BMI >35 Most Commissioned who would for benefit 5-10% weight are in loss parimary 2% achieve care 15kg setting loss at 12 months Bariatric Surgery 30-40% weight loss??? 15-20% weight loss Lifestyle programmes 5-10% weight loss

12 DiRECT Mechanism of Type 2 diabetes reversal? Prof. Roy Taylor Newcastle Can 15kg weight loss be achieved in primary care? Prof. Mike Lean Glasgow

13 DiRECT Diabetes Remission Clinical Trial 2.4m Diabetes UK Funding over 5 years Tyneside & Glasgow Cluster Randomised Design n = 280 (140 intervention, 140 control) Setting: UK Primary Care Control: Usual Diabetes Care Intervention: Counterweight Plus Delivered by Practice Nurses or Dietitians August 2016: Recruitment complete!

14 DiRECT Protocol Primary Study Outcomes Weight loss 15kg at 12 months HbA1c <48 at 12 months (Follow up: 24 months) Inclusion Criteria T2DM up to 6 years duration Age years BMI kg/m 2 HbA1c mmol/mol Secondary Outcomes Mechanisms of reversal Physical Activity Levels Quality of Life Participant and practitioner experiences Main Exclusions Insulin use Weight loss > 5Kg in last 6 months egfr <30 Claustrophobia/metal implants Leslie et al. BMC Family Practice 2016

15 DiRECT Training & Mentoring Training completed for: 18 practice nurses 9 dietitians In 23 intervention GP practices Training (total diet replacement/food reintroduction) 8 hours Deliver TDR Start FR Training (weight loss maintenance) 4 hours Deliver WLM Competence Checks 12 & 24 months Study dietitian mentoring & support

16 Counterweight Plus Programme Core Programme: Total Diet Replacement 12 weeks Food Reintroduction 6-8 weeks Weight Loss Maintenance 86 weeks Optional: Continue TDR up to 20 weeks + 2Kg 4 week FR Rescue Plan + 4Kg 4 week TDR Rescue Plan Review after 1 week, then fortnightly Continue fortnightly reviews Monthly reviews

17 The low calorie diet Product: Counterweight Pro calories/day nutritionally complete 4 sachets (shakes and soups) 55% carbohydrate, 26% protein, 13% fat Additional Considerations: Diabetes & Blood Pressure meds stopped Fluids Fibre supplement Activity

18 Return to normal eating Food Reintroduction Stepped approach, introducing 1 x 400 calorie meal at a time Often creates anxiety Structure and support are essential, especially for thosew who have struggled with weight loss in the past Weight Loss Maintenance Support further weight loss if desired Catch and treat weight regain early

19 Sticking with it (1947)

20 Light at the end of the tunnel (1947)

21 How to help people get through it 1. Discuss weight and diabetes explain the link 2. Emphasise importance of long-term behaviour change 3. Don t underestimate motivation! 4. Manage expectations 5. Involve family

22 How to help people get through it 6. Plan ahead (difficulties/time off) 7. Provide support & monitoring 8. Learn from lapses 9. Reintroduce meals gradually 10. Ongoing support for maintaining weight loss

23 What practitioners have to say I feel it has improved my overall outlook in supporting patients with diabetes, whether they were on the study or not success is a great motivator for patients and staff Anne, practice nurse, 12 month stage It s a privilege to be involved in it s the way forward for type 2 diabetes care Mary, practice nurse, Food Reintroduction stage I ve been amazed at the phenomenal changes in my patients, not just in relation to their diabetes but in all aspects of their health and wellbeing Liz, practice nurse, 24 month stage

24 DiRECt Participant Liver Fat 6 Baseline Post-TDR 6 months

25 What s new on the horizon? PUBLICATIONS T2DM physiology DiRECT baseline abstracts DUK 2017 Main outcomes reported Autumn/Winter 2017 RESEARCH Extended follow up study (+3 years) Weight loss/ T2DM remission in BMI < 27 INFORMATION DiRECT website Newcastle University Webpages

26 Bullet points for diabetes care in a disjointed world It is possible to reverse the pathophysiology of T2DM with significant weight loss. Outside of a research setting more intensive lifestyle interventions are required to help more people achieve the required weight loss Those who are motivated find it relatively straightforward to follow a low calorie diet if support is provided Care should be taken around the return to normal eating and support for weight maintenance Longer term outcomes (>6 months) are as yet unknown, DiRECT is ongoing

27 Sponsor & Partners