Periodic Reporting for period 3 - SOPHIA (Stratification of Obesity Phenotypes to Optimize Future Therapy)
Periodo di rendicontazione: 2022-06-01 al 2023-05-31
Obesity is a global pandemic, currently affecting around 150 million people in Europe and 650 million people worldwide. Obesity complications are common, in fact obesity is associated with some 200 complications, but we cannot yet predict who will develop the complications of obesity. Moreover, there are no predictors for who will respond to obesity treatments. SOPHIA will therefore identify and characterise clinically meaningful subpopulations of patients with obesity using the right treatment for the right people at the right time. The research group will use this knowledge to change how the world talks about obesity based on new understandings and a new vocabulary. It all starts with obesity being a chronic disease, not something people choose to live with. Some of the methods used in SOPHIA will be:
• Creating a database
• Conducting analysis
• Talking to patients to learn about what they fear and hope when it comes to obesity treatment
• Finding a shared value with all stakeholders to ensure better treatment of people living with obesity
We are now thirty-five leading international players from academia, industry and civil society who have joined forces to find better solutions to alleviate the burden and consequences of obesity. The project is supported with funding of €16 million from the Innovative Medicines Initiative (IMI), a joint undertaking of the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA), T1D Exchange, JDRF, International Diabetes Federation (IDF), and Obesity Action Coalition.
• Creating a database
• Conducting analysis
• Talking to patients to learn about what they fear and hope when it comes to obesity treatment
• Finding a shared value with all stakeholders to ensure better treatment of people living with obesity
We are now thirty-five leading international players from academia, industry and civil society who have joined forces to find better solutions to alleviate the burden and consequences of obesity. The project is supported with funding of €16 million from the Innovative Medicines Initiative (IMI), a joint undertaking of the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA), T1D Exchange, JDRF, International Diabetes Federation (IDF), and Obesity Action Coalition.
The collaborative effort of 35 leading international players from academia, industry, and civil society is making significant strides in alleviating the burden and consequences of obesity.
Data federation and analysis: In the first two years, SOPHIA focused on creating a powerful database to analyse obesity-related data. This involved combining information from various cohorts using advanced technology. However, integrating all the data at the same pace proved challenging due to its complexity. In the third year, the project expanded the database by adding two new cohorts and improved its stability and usability. Data from over 63,000 patients were analysed, including genetic information and details from bariatric surgery patients. To aid researchers, tools were developed for remote data analysis, and a working group was formed to collaborate on scientific questions. The project's progress has significantly enhanced obesity research and yielded valuable insights for better treatment and management.
Risks and response in people with obesity without diabetes: Why do certain people with obesity progress to diseases like heart disease or type 2 diabetes at different rates? To answer this question, we analyzed common clinical measurements related to excess body weight and obesity, such as smoking, age, blood biochemistry, and sex. This effort aimed to identify subgroups of patients with obesity who might have varying risks of developing certain diseases like stroke, heart disease, type 2 diabetes, and depression. We also investigated genetic factors, revealing differences in disease risk among individuals with obesity based on their genetic makeup. Additionally, we developed an online tool that predicts an individual's future weight gain after bariatric surgery, providing valuable insights into potential outcomes. This tool is accessible at https://bariatric-weight-trajectory-prediction.univ-lille.fr/. These findings represent significant progress in understanding obesity-related diseases and tailoring interventions for better health outcomes.
Obesity and Type 1 Diabetes: We have brought awareness to the importance of obesity in people living with T1D by disseminating through publications (e.g. Lancet Diabetes & Endocrinology, PMID: 34600607), and sessions in conferences (e.g. EASD-Lancet Symposium during 57th EASD Annual Meeting 2021, 29th annual European Congress on Obesity). Moreover, we joined forces by forming a network in the context of SOPHIA (e.g. Lund, EXE, ULM, KUL, IDIBGI/IDIAP,NOVO, JDRF, T1DE)
Patient Perceptions and Preferences: Work package 7 aims to capture patients’ experiences of living with obesity, with a specific focus on their concerns and their hopes and desires for treatment. Work package 7 has now completed data collection across all tasks as outlined above. Analysis of data is currently underway in preparation for dissemination.
Shared Value Analysis: SOPHIA is working on delivering a common understanding and usage of vocabulary to address obesity as a disease. A panel of experts from different backgrounds co-designed and completed a consensus exercise. The outcomes made it clear that there is a need to differentiate between the World Health Organization and European Commission definitions of obesity and the measurement tools (BMI) or signs of uncontrolled obesity (weight)*.
Data federation and analysis: In the first two years, SOPHIA focused on creating a powerful database to analyse obesity-related data. This involved combining information from various cohorts using advanced technology. However, integrating all the data at the same pace proved challenging due to its complexity. In the third year, the project expanded the database by adding two new cohorts and improved its stability and usability. Data from over 63,000 patients were analysed, including genetic information and details from bariatric surgery patients. To aid researchers, tools were developed for remote data analysis, and a working group was formed to collaborate on scientific questions. The project's progress has significantly enhanced obesity research and yielded valuable insights for better treatment and management.
Risks and response in people with obesity without diabetes: Why do certain people with obesity progress to diseases like heart disease or type 2 diabetes at different rates? To answer this question, we analyzed common clinical measurements related to excess body weight and obesity, such as smoking, age, blood biochemistry, and sex. This effort aimed to identify subgroups of patients with obesity who might have varying risks of developing certain diseases like stroke, heart disease, type 2 diabetes, and depression. We also investigated genetic factors, revealing differences in disease risk among individuals with obesity based on their genetic makeup. Additionally, we developed an online tool that predicts an individual's future weight gain after bariatric surgery, providing valuable insights into potential outcomes. This tool is accessible at https://bariatric-weight-trajectory-prediction.univ-lille.fr/. These findings represent significant progress in understanding obesity-related diseases and tailoring interventions for better health outcomes.
Obesity and Type 1 Diabetes: We have brought awareness to the importance of obesity in people living with T1D by disseminating through publications (e.g. Lancet Diabetes & Endocrinology, PMID: 34600607), and sessions in conferences (e.g. EASD-Lancet Symposium during 57th EASD Annual Meeting 2021, 29th annual European Congress on Obesity). Moreover, we joined forces by forming a network in the context of SOPHIA (e.g. Lund, EXE, ULM, KUL, IDIBGI/IDIAP,NOVO, JDRF, T1DE)
Patient Perceptions and Preferences: Work package 7 aims to capture patients’ experiences of living with obesity, with a specific focus on their concerns and their hopes and desires for treatment. Work package 7 has now completed data collection across all tasks as outlined above. Analysis of data is currently underway in preparation for dissemination.
Shared Value Analysis: SOPHIA is working on delivering a common understanding and usage of vocabulary to address obesity as a disease. A panel of experts from different backgrounds co-designed and completed a consensus exercise. The outcomes made it clear that there is a need to differentiate between the World Health Organization and European Commission definitions of obesity and the measurement tools (BMI) or signs of uncontrolled obesity (weight)*.
Thanks to the advocacy work in IMI SOPHIA – particularly with our work together with EASO on behalf of the SOPHIA project – the European Commission defined obesity as a “chronic relapsing disease, which in turn acts as a gateway to a range of other non-communicable diseases”.
Our federated database is considered a paradigm shift in data analysis, making replication and validation is significantly more efficient and increasing statistical power. Our utilization of this approach synergizes efforts both Europe-wide and globally and remains reusable and sustainable alongside the growth of the research field.
More broadly, the project hopes to change the narrative around obesity, to make it more patient-centric and equitable and to underline that it is a chronic disease, not something people choose to live with. This can change if pathogenesis, risk profiles for complications, and treatment responses are viewed within the context of obesity consisting of several subsets of disease. Our work has begun to identify discordant clusters among patient groups, which is the first step towards stratification and the classification of individuals according to obesity sub-types. With further validation, customized interventions can be developed to address associated risks and optimize therapeutic outcomes.
To date, little attention has been paid to the experience with, management of and access to obesity care for those living with type 1 diabetes. Our research has indicated that the prevalence of obesity among this group is similar to the population without type 1 diabetes and is thus rising alongside global obesity prevalence. Our qualitative research has and will continue to assess the experience of both these patients and the practitioners who administer their care.
By taking using a multi-lateral systems perspective, our ambitions rely on the following requirements:
1) Payers agree to fund treatment
2) Industry generates effective treatments
3) Clinicians are prepared to prescribe treatment
4) Patients are prepared to take treatments
By mapping out where these barriers lie and identifying potential points of entry, we will be able to focus our implementation and impact efforts more precisely. With this, we not only address the challenges to overall wellbeing and gaps in care, but we can also use this to further inform the evaluation of patient-related outcomes and ensure that treatment pathways are patient-centric and tailored to the individual’s real experience.
Our federated database is considered a paradigm shift in data analysis, making replication and validation is significantly more efficient and increasing statistical power. Our utilization of this approach synergizes efforts both Europe-wide and globally and remains reusable and sustainable alongside the growth of the research field.
More broadly, the project hopes to change the narrative around obesity, to make it more patient-centric and equitable and to underline that it is a chronic disease, not something people choose to live with. This can change if pathogenesis, risk profiles for complications, and treatment responses are viewed within the context of obesity consisting of several subsets of disease. Our work has begun to identify discordant clusters among patient groups, which is the first step towards stratification and the classification of individuals according to obesity sub-types. With further validation, customized interventions can be developed to address associated risks and optimize therapeutic outcomes.
To date, little attention has been paid to the experience with, management of and access to obesity care for those living with type 1 diabetes. Our research has indicated that the prevalence of obesity among this group is similar to the population without type 1 diabetes and is thus rising alongside global obesity prevalence. Our qualitative research has and will continue to assess the experience of both these patients and the practitioners who administer their care.
By taking using a multi-lateral systems perspective, our ambitions rely on the following requirements:
1) Payers agree to fund treatment
2) Industry generates effective treatments
3) Clinicians are prepared to prescribe treatment
4) Patients are prepared to take treatments
By mapping out where these barriers lie and identifying potential points of entry, we will be able to focus our implementation and impact efforts more precisely. With this, we not only address the challenges to overall wellbeing and gaps in care, but we can also use this to further inform the evaluation of patient-related outcomes and ensure that treatment pathways are patient-centric and tailored to the individual’s real experience.