ETNICARE - Differences between population groups regarding molecular signatures in type 2 diabetes and its association with clinical treatment response, a mapping based on health inequalities and for knowledge support and precision in the selection of glucose-lowering drugs.
Information for research participants
We would like to ask you if you would like to participate in a research project. In this document you will receive information about the project and what it means to participate.
What kind of project is it and why do you want me to participate?
Cardiometabolic disease includes the most common diseases in the world today, such as cardiovascular disease, type 2 diabetes (T2D) and obesity. These diseases represent one of the greatest and most costly challenges for societies and healthcare systems. They also challenge the pursuit of equal care for all, with increased prevalence and poor response to treatment in certain population groups. This is clearly illustrated in the multiethnic and multicultural Södertälje and Botkyrka area, with large populations from non-Western countries where the prevalence of T2D is high and in many cases response to therapy poor.
Patients often respond differently to the same drug treatment. Often, although not always, this is due to genetic/hereditary factors, which can affect the effectiveness of a drug by affecting interactions between drugs and their target structures (receptors) in the body. More specifically, a drug has its effect/impact on the body when it binds to certain target structures. However, there are certain hereditary differences in, for example, how these target structures (receptors) look, which can mean that in some individuals the drug does not bind as strongly/effectively and then does not have the same effect.
Furthermore, we know that how T2D, characterized by high blood sugar, develops (i.e. which factors contribute most to the high blood sugar / how quickly blood sugar control deteriorates, etc.) differs between different people. This may be due to genetic/hereditary factors (together with cultural factors, diet and nutrition) - and also has an impact on the effectiveness of different treatments. The possibilities to adapt treatments to the individual's genetic conditions are great, but it requires more knowledge about the occurrence and significance of different genetic/hereditary differences.
The purpose of this study is to generate knowledge that can contribute to person-centered care that is based on the individual, i.e. that each person receives the drugs that work best for them. Specifically, we want to determine for different population groups, and for women and men respectively: 1; the presence of genetic/hereditary differences in a receptor (target structure) that is important for the effect of several large groups of drugs that are currently used to treat T2D, and 2; how T2D may behave differently, and finally whether differences regarding 1 and 2 can be linked to differences in drug effectiveness. The hope is that in the future this can contribute to quickly and routinely predicting a response to a particular drug treatment via blood tests and choosing the right drug for each person.
You are informed by your primary health care center about the study, because you meet the following criteria for inclusion in the study; you are between 16-64 years old, have a diabetes diagnosis, and live in Södertälje/ Botkyrka.
The entities responsible for the research is Region Stockholm and Karolinska Institutet and the project is based at Södertälje Hospital. The project has been approved by the Swedish Ethics Review Authority, the registry number for the project at the Swedish Ethics Review Authority is 2023-05743-01.
How does the project work?
If you are interested in participating in the study, you need to sign this consent to participate, and fill out a questionnaire regarding life-style choices (excersize and diet), personal background, drug treatment and diabetes diagnosis. The questionnaire takes about 5-10 minutes to complete and you will be redirected to it after signing this informed consent to participate and to share patient records.
Your questionnaire answers identify if criteria to participate in the prospective part of the study are met, i.e. that: 1. You are currently treated with Metformin / Incretin therapy and 2. Both of your parents were born in Sweden and identify themselves as Scandinavians or Sweeds, or (one or both) your parents were born in the Middle East (Iran, Iraq, Syria or Lebanon) / Turkey, and identify themselves as; Assyrians, Syriacs, or Syrians.
If these criteria are met you will be able to participate also in this part and you will be contacted to schedule a visit to Södertälje Hospital research facilities where blood sampling and a physical examination will be performed. You will be scheduled for three more visits thereafter (at 6, 12 and 24 months). This means that participation in the study may involve a total of four visits over the next two years. Visits are always booked in consultation with you and will take place in the morning before breakfast. A nurse will insert a needle - to avoid repeated pricks - and you will, after having given the first sample, be given a nutritional drink, and further samples will be collected after 0, 15, 30, 60, 90 and 120 minutes. This means that the blood sampling is estimated to take about 2 hours. In total, 63 ml of blood will be taken at each sampling occasion, i.e. about four tablespoons. The physical examination includes measurement of blood pressure, weight and waist circumference.
Possible consequences and risks of participating in the project
Risks associated with participation in the study can be assumed to be small/almost non-existent. No physical intervention beyond blood sampling is planned for any participant and any pain/discomfort is reduced by inserting a needle to avoid repeated pricks. As the data will be coded and then presented at group level, participation does not involve sensitive information being released in any way.
What happens to my data?
The project will collect and register information about you. Your survey responses will supplement the information in national registers regarding the type of oral antidiabetic you are currently treated with, your origin, primary healthcare centre excercise, diet etc. Your blood samples will be analysed for the presence of genetic variants of drug receptors (target structures), as well as for biomarkers including also fasting levels of insulin, blood sugar, blood lipids, etc.
All information collected about you will be coded - i.e. your personal identification number will be replaced with a code so that no information can be linked to you without access to the code key - and saved in security-classified systems at Karolinska Institutet. The code key is stored separately at KI, accessible to the principal investigator responsible for personal data.
The General Data Protection Regulation (GDPR) regulates the handling of personal data in all of KI's operations. All compilation of data will be presented at group level, i.e. no personal data will be made available. Blood samples will be available for the study for 18 months after the last sample, i.e. some samples will then have been stored for approximately 4.5 years. This is to ensure that all analyses have time to be completed. Biological material that remains after the project has ended will be stored in a biobank for 7 years. Collected data will be retained by the entities responsible for the research and collaborating organizations, and will not be transferred to another research institute or another country. Your answers and your results will be processed so that unauthorized persons cannot access them. Responsible for your personal data is Södertälje Hospital and the principal investigator; Associate Professor and Senior Lecturer Camilla Krizhanovskii. According to the EU Data Protection Regulation, you have the right to access the data about you that is processed in the project free of charge, and to have any errors corrected if necessary. You can also request that data about you be deleted and that the processing of your personal data be restricted. However, the right to deletion and restriction of processing of personal data does not apply when the data is necessary for the research in question.
If you would like to access the information, please contact Principal Investigator Camilla Krizhanovskii at Lagmansvägen 15, 15286 Södertälje and telephone number 0705532383.
For questions about the General Data Protection Regulation (GDPR), please contact the Data Protection Officer at KI Mats Gustavsson at dataskyddsombud@ki.se.
If you are dissatisfied with how your personal data is processed, you have the right to file a complaint with the Swedish Data Protection Authority, which is the supervisory authority.
What happens to my samples?
The samples taken are stored in a so-called biobank. The name of the biobank is Stockholms Medicinska biobank with IVO number 914. The head (responsible) of the biobank is Region Stockholm. The sample collection will be stored at the Clinical Trials Unit, Södertälje Hospital. Samples will be handled in accordance with the Biobanks Act 2023:38. All samples will be coded (pseudonymized), which means that they cannot be linked directly to you as a person. The code key is stored at Södertälje Hospital and at Karolinska Institutet. The code key is processed so that unauthorized persons cannot access them. You have the right to refuse to have the samples saved without explanation. If you agree to the samples being saved, you have the right to later and without explanation withdraw (undo) that consent. In that case, your samples will be discarded.
If you wish to withdraw your consent, please contact the principal investigator Camilla Krizhanovskii at Lagmansvägen 15, 152 86 Södertälje and telephone number 0705532383
The samples may only be used in the manner to which you have given consent. If you agree that we may preserve and use your samples for future purposes, you must specifically consent to this. If there is research that has not yet been planned, the Ethics Review Authority will decide whether you should be asked again.
How do I get information about the results of the project?
You do not have to be notified of the results of the analysis performed if you do not want to. However, you may have all your data and the results of the entire project/study by contacting the principal investigator for the project, camilla.krizhanovskii@regionstockholm.se. You can also make an active choice when filling out the questionnaire to take part in a summary of the study results after the study is completed.
Insurance and compensation
According to the Patient Injury Act, voluntary research participants are considered patients. As a voluntary research participant, you are therefore covered by the patient insurance that the Swedish regions have with the Löf region mutual insurance company (Löf). As a research participant, you are entitled to travel compensation for travel to and from the scheduled visits corresponding to an amount of up to a total of SEK 200. Travel compensation is tax-free. Lost income is not compensated.
Participation is voluntary
Your participation is voluntary and you can choose to discontinue participation at any time. If you choose not to participate or want to discontinue your participation, you do not need to state why, and it will not affect your future care or treatment. If you want to discontinue your participation, you should contact the person responsible for the project (see below).
Responsible for the project
The person responsible for the project is Associate Professor and Senior Lecturer Camilla Krizhanovskii, Lagmansvägen 15, SE-152 86 Södertälje, Tel:
0046705532383, e-mail: camilla.krizhanovskii@regionstockholm.se / camilla.krizhanovskii@ki.se