Individually Tailored Treatment of Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 2,246
- 试验地点
- 8
- 主要终点
- Composite endpoint: All cause mortality, non-fatal myocardial infarction, coronary revascularization, cardiac arrest with resuscitation, heart failure, non-fatal stroke, progression of nephropathy or retinopathy, severe hypoglycaemia and cancer
研究概览
简要总结
The prevalence of Type 2 diabetes (T2D) is rising rapidly worldwide. In Denmark approximately 8% of adults have T2D and more than 25.000 are diagnosed each year. This has vast consequences for society and the patient.
Standardized treatment aiming at normalizing blood glucose and hypertension comparable to healthy individuals, have been tested in large studies. The effect on cardiovascular disease and other complications have been modest at best and one study showed an increased mortality with intensive treatment. The standardized treatment often results in polypharmacy, which increases the risk of patients discontinuing treatment.
We propose a new approach to treatment of T2D, where the patients' individual characteristics are considered. The aetiology of the diabetes can be different, which warrants different treatment. Many patients have concomitant illness which can affect the way the patient is treated. A tight regulation of blood glucose can in some patient constitute a risk of adverse effects, especially hypoglycemia. In that sense individual targets for the treatment are important. Effective lifestyle treatment has importance for a successful outcome and we therefore offer an application that can help the patient and the physician organizing activity individually.
The objective of individual treatment is to choose the most effective medication. If a prescribed drug does not have the desired effect it should be replaced with a different drug. The overall goal is to reduce the number of substances and side-effects, but simultaneous improve treatment and reduce the incidence of cardiovascular and other diabetes-related complications. This will in turn result in improved quality of life and improved adherence to treatment.
The potential effect of individual tailored treatment of T2D is to improve the guidelines of treatment, not only to improve the patients' health, but also to reduce the socioeconomic consequences of the growing T2D prevalence
详细描述
The design is a prospective controlled open-label multicenter intervention study. General practitioners in region of southern Denmark are responsible for the treatment, while central visits for additional data sampling are located at Odense University hospital, Holbaek Hospital, Naestved Hospital, and hospital of south west Denmark, Esbjerg.
The inclusion phase will run for 2 years. The follow-up phase is 10 years from inclusion.
Registries will be employed in both the characterization of patients and in the sampling of end-points. Concomitant medication will be sampled from the National Prescription Database. Concomitant illness and identification of endpoints will be sampled from the Registry of Patients, Registry on Cause of Death, the Danish Registry on Regular Dialysis and transplantation, the Danish general practice database, The National Indicator project, Statistics Denmark, The National Indicator Project, The Danish Cancer Registry, the DD2-database and local databases.
Treatment The control group will be treated according to national guidelines. The intervention group will be treated according to individual assessment. Several approaches will be employed to achieve individualization.
- Identification of pathophysiological traits in order to chose the correct medication targeting hyperglycaemia. Identification of pathophysiological traits, through genetic testing, GAD antibodies and C-peptid level, will individualize the treatment of hyperglycaemia according to the following groups: MODY (maturity onset diabetes of the young), LADA (latent autoimmune diabetes of adults), steroid-induced diabetes, insulinopenic diabetes, secondary diabetes and patients with insulin resistance. Specific treatment algorithms will be applied in each group.
- Individualized targets for all patients with regard to hyperglycaemia. The target will be chosen on the basis of age, motivation, skills, risk of hypoglycaemic events, therapy resistance, initial hba1c and concomitant illness. As these factors change the target can be adjusted accordingly.
- Hemodynamic characterization by impedance cardiography will be used in order to individualize anti-hypertensive medication.
- Individualized targets for all patients with regard to hypertension. The target will be chosen on the basis of concomitant risk factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly discovered diabetes patients clinically classified as T2D patients of both sex'
- •Participation in the DD2 cohort
- •Signed informed consent
排除标准
- •Patients with age under 18
- •Type 1 diabetes. If patients at baseline investigations have age<30 years AND C-peptid<300pmol/l AND GAD-ab titer> 20 IU/ml they are also considered as having type 1 diabetes.
- •Life expectancy below 2 years
- •Psychiatric or mental disease that affects the patients ability to give informed consent or participate adequately in the study
- •Ongoing abuse of alcohol or illicit drugs that affects the patients ability to give informed consent or participate adequately in the study
- •Participation in any other clinical trial
- •Pregnancy at time of inclusion or planned future pregnancy (A negative pregnancy test is mandatory before inclusion. In women who are sterile, infertile or is postmenopausal (12 month without menstruation) this test is omitted.)
结局指标
主要结局
Composite endpoint: All cause mortality, non-fatal myocardial infarction, coronary revascularization, cardiac arrest with resuscitation, heart failure, non-fatal stroke, progression of nephropathy or retinopathy, severe hypoglycaemia and cancer
时间窗: 10 year
次要结局
- Quality of life(10 years)
- Socioeconomic cost(10 years)
- All cause mortality(10 years)
研究者
Jacob Volmer Stidsen
MD
Odense University Hospital