Abstract
Type 2 diabetes er en hastigt voksende sygdom på verdensplan. I Danmark anslås det, at op mod 8 % af den voksne befolkning har type 2 diabetes. Der diagnosticeres mere end 25.000 nye patienter hvert år. Dette har store konsekvenser både samfundsmæssigt og individuelt.
Formålet med forsøget er at forbedre behandlingen af type 2 diabetes igennem en individuel behandling. Altså identificere de markører, der kan hjælpe til en rigtig og præcis behandling for den enkelte person med diabetes.
Den overordnede målsætning er at reducere medicinforbruget, bivirkninger og diabetesrelaterede komplikationer såsom hjerte-kar-sygdom. Vi ønsker at inkludere i alt cirka 2.200 deltagere delt i to grupper; en interventionsgruppe, der vil modtage individuel behandling og en kontrolgruppe, der får den behandling, som tilbydes i dag af egen læge. I interventionsgruppen vil alle deltagere blive karakteriseret i forhold til hvilke underliggende årsager, der er til diabetes og eventuelt forhøjede blodtryk. Ud fra denne karakterisering vil behandlingen blive fastlagt efter nye mere individuelle retningslinjer.
Deltagere i kontrolgruppen vil blive behandlet efter de til enhver tid gældende nationale retningslinjer hos deres praktiserende læge.
Projektet forventes at give ny viden om, hvorvidt en individuel behandling af type 2 diabetes er bedre end de nuværende generelle behandlingsanbefalinger.
Formål
Primary objectives is to assess the effect of individually tailored treatment compared to contemporary “treat-to-target” approach on the incidence of a composite endpoint consisting of micro- and macrovascular events, cancer, severe hypoglycaemic events and over-all death over a 10 year period.
Secondary objectives is to show that individualised treatment reduce the number of pharmacological agents used, improve quality of life and is cost efficient. Further, it is the objective to assess the effect of individualised treatment on surrogate markers of cardiovascular disease, including markers of organ damage.
Studiepopulation
Inclusion criteria:
- Member of the DD2 cohort
- Patient at a GP participating in the IDA study
- Not diagnosed with Type 1 Diabetes, defined as age <30 years at DD2 enrollment, fasting C-peptide<300pM, and Gad65-ab>20IU/ml (see below)
- Life expectancy above 2 years
- No participation in other clinical trials
- Willing to provide written informed consent
Artikler
- Domazet (2023). Accelerometer-derived physical activity and sedentary behaviors in individuals with newly diagnosed type 2 diabetes: A cross-sectional study from the Danish nationwide DD2 cohort. Frontiers in Sports and Active Living.
- Abstract - Domazet (2022). EASD2022
- Stidsen (2022). Risk of cardiovascular events associated with pathophysiological phenotypes of type 2 diabetes. European Journal of Endocrinology.
- Hasific (2020). Extent of arterial calcification by conventional vitamin K antagonist treatment. PLOS ONE.
- Stidsen (2018). Pathophysiology‐based phenotyping in type 2 diabetes: A clinical classification tool. Diabetes/metabolism research and reviews.
- Stidsen (2017). Protocol for the specialist supervised individualised multifactorial treatment of new clinically diagnosed type 2 diabetes in general practice (IDA): a prospective controlled multicentre open-label intervention study. BMJ Open.
- Poster: Stidsen (2014). Pathophysiological based phenotyping in type 2 diabetes - a clinical tool. Diabetologia.
- Poster: Stidsen (2013). Different Pathophysiological Phenotypes among Newly Diagnosed Type 2 Diabetes Patients.
DD2 er ledet af Steno Diabetes Centrene
