Gastric Balloon

Allurion Programme For Weight-Loss

Author
Dr. Samir Rahmani
Lady writing a bike

It is well documented that for people who are overweight or obese, achieving just a small amount of weight loss (starting at just 5% of initial weight lost) has a significant impact on health. This small amount of weight loss can reduce the risk of a diagnosis of type 2 diabetes and improve the health and blood sugar control in people already living with type 2 diabetes.

What is the new data from Allurion?

For the first time, the Allurion Programme has been clinically proven to treat patients living with type 2 diabetes and prediabetes and bring them into disease remission (remission means that blood sugar levels are below the diabetes range)2. The procedureless Allurion Programme – including an easy-to-swallow gastric balloon pill – is a new option for healthcare professionals to help manage their patients living with diabetes and prediabetes.

What were the main results from the clinical study?

This published data has shown that the Allurion Gastric Balloon Programme can be an effective option to treat type 2 diabetes and prediabetes and bring them into remission.

The clinical study included 226 patients that followed the Allurion Programme for weight loss. All patients included in the trial were diagnosed as Type 2 diabetic or pre-diabetic (in other words diagnosed as highly likely to go on to develop type 2 diabetes in the future)

On average patients lost 17.7kg (16.2% of their total initial body weight) at 4 months.

During the trial, the researchers measured haemoglobin A1C (HbA1c a measure of blood sugar control, the lower the number the healthier). All patients at the start of the clinical trial had unhealthy levels of HbA1c, meaning they were all diagnosed with pre-diabetes or type 2 diabetes

For patients living with type 2 diabetes their HbA1c levels improved from 7.0±0.6% to 5.5±1.1%, and for those who living with pre-diabetes their HbA1c levels improved from 6.0±0.2% to 4.9±0.7%. These significant reductions in HbA1c meant that patients in both groups were in complete disease remission by the end of the clinical trial (in just 4 months) with their HBA1c levels lowering to normal range found in people living without diabetes.  

How does this compare with other bariatric procedures?

Studies following other bariatric surgical procedures have demonstrated that a weight loss of around 15kg can lead to remission of type 2 diabetes in most people living with obesity and type 2 diabetes. This remission is even more likely if the patient loses the weight nearer to their diabetes diagnosis and quickly.

This new ground-breaking data on the Allurion Programme builds on these studies, demonstrating that a lifestyle change programme alongside the Allurion Balloon (formerly known as the Elipse Balloon) can also deliver clinically significant and lifechanging health benefits.

Maintaining healthy lifestyle changes and weight loss is vital to sustain these health benefits. Published evidence demonstrates that the Allurion Programme – a lifestyle change programme, digital tools and the temporary Allurion Balloon (formerly known as the Elipse Balloon) – delivers sustained weight loss, with up to 95% of the weight lost maintained by patients a year down the line8

Why is this topic so important?

More people than ever before are living with Type 2 diabetes and prediabetes, with around 5 million people in the UK alone diagnosed with diabetes and almost 14 million at high risk of going on to develop the disease (having prediabetes), with more people undiagnosed and rates continuing to rise.

Not only does this have significant costs on the NHS and other public services (about 10% of the total NHS budget), but the personal health and wellbeing burdens of the disease are immense, with people affected by complications of amputations, sight loss, premature death, increased likelihood to go be admitted to hospital, and increase rates of depression (to name just a few).

Scalable and effective treatment options are urgently needed. As weight management is thought to be the most important therapeutic task for most people living with obesity and type 2 diabetes, having a range of effective weight management treatments is vital.

The health benefits of weight loss accrue with a 5% loss and go up from there. A weight loss of 7% can mean the difference between developing type 2 diabetes and not. For people who are on the cusp of having diabetes, a 7-8% weight loss pulls them back from the brink.

The medical community will be thrilled with these results as it will really make a difference in the health and wellbeing of their patients.  Also, let’s not forget that obesity has a substantial health impact with over 200 possible complications, affecting many organs and systems8. This weight loss will also be delivering wider health benefits, in addition to improvements in quality of life.

Where will the data be published?

This ground-breaking data has been peer-reviewed and published. The data was selected by a panel of experts to be presented at The Obesity Society (TOS) Obesity Week 2021.

What is the difference between type 1 and type 2 diabetes?

This data only includes patients at risk from, or diagnosed with Type 2 diabetes.

There are two main types of diabetes: type 1 and type 2. They have similar symptoms, and over time they can lead to many of the same complications. However they are very different diseases. Around 90% of people living with diabetes have type 2 diabetes.

Type 1 diabetes is an autoimmune disease in which a person’s body cannot produce insulin (a hormone needed for the regulation of sugar levels in the bodies blood stream and cells) on its own.

Type 2 diabetes is a disease where the body produces insulin, but the body cannot respond to it in a normal way.   

For people with type 2 diabetes, the condition can develop over many years. In fact, a person with type 2 diabetes may not know they have it until they have symptoms of a complication.

 Uncontrolled and high blood sugar levels can lead to both short- and long-term health problems.

How can type 2 diabetes be prevented?

There are many factors that contribute to the risk of type 2 diabetes, some of which you can control and others you can’t. There are some proven lifestyle choices and changes that can help prevent or delay the onset of type 2 diabetes and prediabetes. The first thing to do is find out if you are at risk. Go to Diabetes UK and complete their quick risk quiz.

Diet. The best kind of diet to prevent type 2 diabetes is a healthy, well varied one – rich in fruits, vegetables, lean proteins, wholegrain carbs and healthy fats.

Exercise. According to the NHS, the optimal amount of exercise for adults is 150 minutes of moderate-intensity activity every week. This can translate to 30 minutes of exercise per day, 5 days a week.

Weight management. Aiming to reach and maintain a healthier weight is a powerful way to reduce the risk of developing type 2 diabetes. In fact, weight management is thought to be the most important therapeutic route for most people living with obesity and type 2 diabetes.

Is a balloon as extreme as having a gastric band?

The Allurion Balloon is placed during a 15-minute consultation with a doctor. Taken into the body as an easy-to-swallow gastric balloon pill, it does not require any anaesthesia, endoscopy or surgery.

The Allurion Balloon (formerly known as the Elipse Balloon) provides patients with an alternative to weight loss surgery such as the gastric band and gastric bypass. Although Allurion is not a replacement for bariatric surgery, the temporary gastric balloon pill could be used as early intervention or for those who do not want, or cannot have, surgery.

Bariatric surgery to reduce the size of the stomach is highly effective, but anaesthesia for somebody who is living with obesity can be risky. Those who want to undergo the surgery must also undergo a long period of preparation to ready them physically and psychologically. It is expensive, and there is a long waiting list in the UK.

Allurion’s swallowable gastric balloon pill can play a role at an earlier stage or for those who do not want surgery or are not suitable for it. It is great for people who are looking for significant weight loss – for example as alternatives to weight management surgery, or those people that have found diet and exercise alone are not effective.  

How can I find a gastric balloon near me?

Get in touch with Allurion to arrange a weight loss consultation and find out more about the benefits of a weight management programme based on the Allurion Balloon (formerly known as the Elipse Balloon).

References

- Ienca R, Rosa M, Pagan Pomar AA, Hansoulle J, and Caballero A. Emerging Role of the New Swallowable Gastric Balloon in Type 2 Diabetes and Prediabetes Treatment. Poster 114. Presented at TOS Obesity Week 2021.

- National Diabetes Statistics Report, 2017.Centers for Disease Control and Prevention website. https://www.cdc.gov/diabetes/data/statistics/statistics-report.html External link. Updated July 17, 2017. Accessed October 25, 2017

- Wing RR, Lang W, Wadden TA, et al. Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes. Diabetes Care. 2011;34(7):1481-1486. doi:10.2337/dc10-2415

- Ryan DH, Yockey SR. Weight Loss and Improvement in Comorbidity: Differences at 5%, 10%, 15%, and Over. Curr Obes Rep. 2017;6(2):187-194. doi:10.1007/s13679-017-0262-y

- Magkos F, Hjorth MF, Astrup A. Diet and exercise in the prevention and treatment of type 2 diabetes mellitus. Nat Rev Endocrinol. 2020;16(10):545-555. doi:10.1038/s41574-020-0381-5

Weight loss and diabetes | Diabetes UK

- Anderson JW, Kendall CW, Jenkins DJ. Importance of weight management in type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll Nutr. 2003;22(5):331-339. doi:10.1080/07315724.2003.10719316

- Ienca R, Giardiello C, Badiuddin F, et al. Long-Term Efficacy of the Elipse Gastric Balloon System: An International Multicenter Study. Oral Presentation. Presented at TOS Obesity Week 2020.

- Yuen M., Earle R., Kadambi N., et al. A systematic review and evaluation of current evidence reveals 195 Obesity-Associated Disorders (OBAD). The obesity society 2016 abstract book 2016:92

Author
Dr. Samir Rahmani
Consultant Laparoscopic, Bariatric and General Surgeon