BETAMI Study: Treatment with or without Beta-blockers in Patients with Myocardial Infarction (Active)
John Munkhaugen is one of the two project leaders for the BETAMI study, a Norwegian-Danish multicentre study investigating the continued importance of beta blockers in post-acute heart attack treatment. The study, initiated in autumn 2018, aims to enroll 5,700 patients with myocardial infarction but without heart failure. These patients will be randomly assigned to receive either beta blocker treatment or not treatment. Over an average follow-up period of 3.5 years, participants will be monitored through questionnaires and endpoint registrations including new heart attacks, arrhythmias, heart failure admissions, cardiovascular death, and overall mortality.
Additional sub-studies focusing on clinical, psychosocial, pharmacological, and health economic aspects are planned, building on previous NORCOR findings. Funding of 27 million has been secured from Helse Sør-East (KlinBeForsk) and the Research Council of Norway. Patient enrollment is scheduled to conclude in December 2023. The project is led by Dan Atar at Oslo University Hospital HF (coordinating research site), with research also being conducted at participating institutions/hospitals including Vestre Viken HF, Diakonhjemmet hospital, Hospital Innlandet HF, Lovisenberg Diakonale Hospital, and Akershus university hospital HF.
Duration: September 2018-December 2035. This study has been approved by the Regional Committee for Medical and Health Research Ethics under application number 2018/455.
Research results:
- The Danish-Norwegian randomized trial on beta-blocker therapy after myocardial infarction: Design, rationale, and baseline characteristics. European Heart Journal – Cardiovascular Pharmacotherapy, 2023
NorEx Study – Norwegian Trial of Physical Exercise After Myocardial Infarction (Active)
John Munkhaugen is a member of the project management team for The Norwegian Trial of Physical Exercise After Myocardial Infarction (NorEx) study, led by NTNU in Trondheim. This study aims to determine if a three and a half year exercise program can prolong life and improve overall health of patients who have experienced heart attacks.
The NorEx study will randomize a total of 13,000 patients from the heart attack register into three groups. Some participants will receive standard physical activity guidance, while others will participate in a structured training program with close monitoring for three to four years. The intensity of the training will be customized to each individual’s fitness level, with progress assessments of the patient’s condition conducted every six months.
Furthermore, the study will encompass a range of projects including clinical, biobank, psychosocial, and health economic components. Senior physician Erik Gjertsen, who is part of the steering committee, will oversee patient recruitment at Drammen Hospital. The study has received 50 million in funding from Helse Sør-East (KlinBeForsk) and the Research Council of Norway.
The project, led by Kaare Harald Bønaa at NTNU, involves research collaboration with Vestre Viken HF. The study will be conducted from November 2019 to December 2034 and has been approved by the Regional Committee for Medical and Health Research Ethics under application number 2019/797.
CORTAD Study: Registry-based Randomized Trial of Glucocorticoid Replacement in Adrenal Insufficiency (Active)
The aim of this study is to determine the most effective replacement therapy for adrenal insufficiency, focusing on its impact on quality of life, ability to work, and various metabolic parameters. This includes investigating how two commonly used replacement regimens influence weight, waist circumference, blood sugar, lipids, blood pressure, frequency of adrenal crises, and mortality rates. Previous research suggests that treatment with the depot tablet Plenadren (hydrocortisone) may offer a more physiological approach compared to Cortisone (cortisone acetate) administered three times daily. However, it is important to consider that while Plenadren may offer advantages, it comes at a higher cost than Cortisone. In this study, the goal is to determine which treatment option yields the best outcomes for patients, primarly in terms of improving quality of lif and ability to work.
Project leader: Eystein Sverre Husebye at Helse Bergen HF – Haukeland University Hospital (Coordinating Research Unit). Participating research institutions: Oslo University Hospital, Vestre Viken Hospital, Haraldsplass Diakonale Hospital, Levanger Hospital, Nord-Trøndelag Hospital Trust, University Hospital of North Norway, St. Olavs Hospital, Health Møre and Romsdal, Health Fonna, Health Stavanger – Stavanger University Hospital, Health Førde, Vestfold Hospital, Southern Norway Hospital, Akershus University Hospital, Østfold Hospital, Innlandet Hospital. Stina Therese Sollid leads the study locally at Drammen Hospital.
Duration: March 2023-February 2027. Approved by the Regional Committee for Medical and Health Research Ethics under application number: 398710.
DIASA 1 Project: Glucose Metabolism in Norwegian and South Asian Women with Previous Gestational Diabetes (Active)
The research project aims to investigate the occurence of prediabetes and diabetes in women of Nordic and South Asian descent one to three years after experiencing gestational diabetes. This population is at a high risk for developing type 2 diabetes within 5 to 10 years post-gestational diabetes, with South Asian women showing particular vulnerability. The study data will be cross-sectionally analyzed, with all participating women undergoing oral glucose tolerance tests. Additionally, a qualitative component will involve focus group interviews to explore self-perceptions of health, barriers to health-promotion, and illness among a subgroup of both Nordic and South Asian women.
Furthermore, participants will have the opportunity to partake in educational group sessions focusing on preventive lifestyle measures. These sessions will offer randomized interventions including physical activity, dietary guidance, or coping strategies. The incidence of diabetes will be assessed in the groups after 5 years through a register search.
The project is led by Kåre Inge Birkeland at Oslo University Hospital HF (coordinating research site), with participating institutions including Vestre Viken HF and Akershus University Hospital HF. Stina Therese Sollid leads the study locally at Drammen Hospital.
The research period will span from August 2018 to December 2026 and has been approved by the Regional Committees for Medical and Health Research Ethics with application number 2018/689.
Research results
N-terminal pro-B-type natriuretic peptide levels vary by ethnicity and are associated with insulin sensitivity after gestational diabetes mellitus. Cardiovascular Diabetology 2024
DIASA 3 Project: Investigation of the Impact of Four Diabetes Medications on Glucose Metabolism in South Asian Women with Pre-Diabetes (Active)
In the DIASA 3 study, we aim to evaluate the effectiveness of four different diabetes medications currently available in Norway on women of South Asian descent who have pre-diabetes. The goal is to identify the most effective medication(s) for this specific population.
A total of 64 women from the DIASA 1 study (presented above) will be divided into four groups to test metformin, pioglitazone, empagliflozin, or linagliptin over a 12-week period. The primary objective is to improve insulin resistance in the liver, with secondary goals of improving whole-body insulin resistance and insulin secretion. Advanced measurement techniques such as euglycaemic clamp, 5-point glucose load, and CT scans of abdominal fat distribution will be employed. The findings from DIASA 3 will inform the design of a larger randomized controlled drug trial for South Asian patients with established type 2 diabetes in the future (DIASA 6).
Kåre Inge Birkeland at Oslo University Hospital HF (coordinating research unit) is the project leader, with research conducted in collaboration with Vestre Viken HF and Akershus University Hospital HF. Locally, Stina Therese Sollid leads the study at Drammen Hospital.
The research period will span from November 2018 to December 2026 and has been approved by the Regional Committees for Medical and Health Research Ethics with application number 2018/1584.
DIAbetes in South Asians – DIASA 4: A Cohort Study in General Medical Practice (Active)
The project aims to investigate the impact of optimized follow-up care in general practice for South Asian patients with type 2 diabetes on various health parameters, including HbA1c, blood pressure, lipids, and the development of late complications. A cohort of 200-300 South Asian patients will be invited to undergo diabetes checks twice a year for a period of 5 years. Their own GP will administer treatment, with assistance from a study nurse who will conduct anthropometric measurements, monitor blood pressure, carry out blood tests, and perform foot examinations. The study nurse will ensure all information is accurately recorded in Noklus’ diabetes journal, which is also utilized for data collection for the Diabetes Register for adults. The intervention will include monthly lunch meetings between general practitioners and an endocrinologist to discuss challenging patient cases. The impact of this intervention will be evaluated through interviews with the doctors before and after the study. By adhering to national guidelines for diabetes treatment, this project seeks to enhance the quality of care for South Asian patients with type 2 diabetes in general practice.
Project leader: Cecilie Wium and Kåre Inge Birkeland from Oslo University Hospital HF (coordinating research site). Participating institutions include Vestre Viken HF, Stovner Medical center, and Akershus University Hospital HF. Stina Therese Sollid is leading the study at Drammen Hospital.
The project will span from January 2019 to December 2027 and has been approved by the Regional Committee for Medical and Health Research Ethics, with application number 2018/1842.
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