Achieving and maintaining substantial weight loss allowed 8 out of 10 people remission from type 2 diabetes, as well as lowering blood pressure and reducing the need for anti-hypertensive medications, found the Diabetes Remission Clinical Trial (DiRECT) published in Diabetologia.
The weight loss phase is followed by support to choose foods and eat wisely for weight loss maintenance. Maintaining the 15 kg weight loss allowed 8 out of 10 people to become free from type 2 diabetes, without the need for diabetes medications for at least 2 years.
A weight management programme was developed by researchers at the Universities of Glasgow and Newcastle for the Diabetes UK-funded DIabetes REmission Clinical Trial (DIRECT). It involves an initial 12 weeks on a nutritionally complete formula diet (low calorie soups and shakes) which will induce weight loss of over 15 kg if followed fully. Diabetes and blood pressure drugs were stopped at the start, and only re-started if blood sugar or blood pressure rose.
The weight loss phase is followed by support to choose foods and eat wisely for weight loss maintenance. Maintaining the 15 kg weight loss allowed 8 out of 10 people to become free from type 2 diabetes, without the need for diabetes medications for at least 2 years.
This study, published in the journal Diabetologia (the journal of the European Association for the Study of Diabetes [EASD]), looked at 143 people who started the diet programme, with more than half (78 people) on tablets for high blood pressure at the start (and 44 on two or more drugs). The researchers found that, overall, average blood pressure fell steadily as people lost weight. And blood pressure remained lower after the formula diet period finished, and then at 12 and at 24 months.
For those not previously treated for high blood pressure, blood pressures fell sharply from week one. For those who had stopped their blood pressure tablets, blood pressure still fell, although more slowly. Just over a quarter (28%) needed to reintroduce a blood pressure tablet during the formula diet period. However, researchers also found that the same proportion of participants (28%) were able to remain off their medications for at least two years.
Prof Mike Lean, from the University of Glasgow, said: "We wanted to evaluate the safety and efficacy of withdrawing blood pressure medication when beginning our specially-designed weight-loss programme for type 2 diabetes, and we are really pleased with the results.
"Our study shows that, in addition to possible remission from type 2 diabetes, there are other very important health benefits, as weight loss is a very effective treatment for hypertension and its associated serious health risks.
"Currently, over half of all the 4.5 million people with type 2 diabetes in UK also require tablets for hypertension, to reduce serious vascular complications. Being overweight is the main cause, and losing weight can bring a remission from hypertension for many, as well as a remission of diabetes. Withdrawing blood pressure medications is safe, provided people lost weight and blood pressure was checked regularly, in case tablets needed to be reintroduced.
"The DiRECT trial was done entirely in primary care. The evidence shows that GPs can safely offer an evidence-based intensive weight management intervention, aiming for substantial weight loss and remission of type 2 diabetes. The study further highlights the links between diet, weight, type 2 diabetes and hypertension, and how long-term support to maintain weight loss is vital."
Professor Roy Taylor, from Newcastle University, said: "Guidelines encourage doctors to start tablets but there have been few demonstrations of how tablets can be stopped.
"My patients, like so many, do not like swallowing multiple tablets, and this study is important as we can now reassure them that stopping blood pressure tablets is not only safe but also good for their health. We've shown that when substantial weight loss is achieved and maintained, patients can effectively manage both their blood pressure and type 2 diabetes without drugs."
Dr Wilma Leslie, University of Glasgow, said: "The potential to no longer need medications for blood pressure and diabetes is a big incentive for people. We hope our results will reassure health professionals that this is possible, and encourage the wider provision of diabetes remission services."
Dr Elizabeth Robertson, Director of Research at Diabetes UK, said: "These important results show that the Diabetes UK-funded DiRECT low-calorie, weight management programme not only helps some people put their type 2 diabetes into remission, but can also lower blood pressure, allowing some people to safely stop taking their blood pressure medication.
"We're delighted to see more evidence of the life-changing impact of the DiRECT programme on people's health. This makes us even more determined to make sure as many people as possible have access to type 2 diabetes remission services."
Study details
Antihypertensive medication needs and blood pressure control with weight loss in the Diabetes Remission Clinical Trial (DiRECT)
Authors: Wilma S. Leslie, Eman Ali, Leanne Harris, C. Martina Messow, Naomi T. Brosnahan, George Thom, E. Louise McCombie, Alison C. Barnes, Naveed Sattar, Roy Taylor, Michael E. J. Lean.
Published in Diabetologia on 31 May 2021
Abstract
Aims/hypothesis
Our aim was to evaluate the safety and efficacy of a planned therapeutic withdrawal of all antihypertensive and diuretic medications, on commencing a formula low-energy diet replacement, targeting remission of type 2 diabetes.
Methods
Post hoc analysis of changes in BP, antihypertensive medication prescriptions and symptoms during the initial total diet replacement phase was performed in the intervention arm of the Diabetes Remission Clinical Trial (n = 143) and in the subset (n = 69) who discontinued antihypertensive medications at the start of total diet replacement. The Counterweight-Plus total diet replacement provided about 3470 kJ/day (830 kcal) with automatic reductions in all nutrients, including sodium, to achieve marked negative energy balance and rapid weight loss over 12–20 weeks, with regular BP monitoring and an antihypertensive reintroduction protocol based on current clinical guidelines.
Results
Of 143 intervention group participants who commenced total diet replacement, 78 (55%) were on treatment for hypertension at baseline. The overall mean BP fell significantly from the start of total diet replacement (week 1) and was significantly lower at week 20, after total diet replacement finished, and also at 12 and 24 months. Of the 78 participants previously on treatment for hypertension, 65 (83%) stopped all antihypertensive and diuretic medications as per protocol, and four (5%) stopped some drugs. These 69 participants experienced no immediate (within the first week) change in BP, but their mean BP fell significantly from 9 weeks. No excessive rises in BP were recorded in individuals, but antihypertensive medications were reintroduced during total diet replacement to manage raised BP for 19/69 (27.5%) participants, mostly within the first 3–7 weeks, despite some weight loss. Reintroduction of antihypertensive medications was necessary for 5/19 participants previously on one drug, and for 14/19 previously on two or more drugs. Of the 69 who stopped antihypertensives, 19 (28%) remained off medications at 24 months. Among the 53 participants who achieved sustained remissions of diabetes at 24 months (with a mean weight loss of 11.4 kg), 31 had been previously treated for hypertension. Twenty-seven stopped medication at baseline, and 15/27 required reintroduction of antihypertensive medications. Mild to moderate dizziness, suggesting some postural hypotension, was reported during total diet replacement by 51 participants, 15 of whom had recorded dizziness at baseline prior to starting total diet replacement, with nine of these on antihypertensive or diuretic medications.
Conclusions/interpretation
Replacing antihypertensive medications with a 3470 kJ/day (830 kcal) diet to induce weight loss reduces BP substantially and may increase mild dizziness. It is safe to stop antihypertensives, but BP should be monitored regularly, particularly for those taking two or more antihypertensives, as over two-thirds will require reintroduction of some medications. Long-term support to maintain weight loss is vital.
Full study in Diabetologia (Open access)
See also from the MedicalBrief archives:
Low and very-low carb diets for type 2 diabetes remission – Systematic review