Diet, Physical Exercise and Metabolic Control (DEMAND) Intervention to Reduce the Incidence of Major Neurocognitive Disorders Among Individuals With Type 2 Diabetes Combined With Mild Neurocognitive Impairment - a Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- inclusion rate
研究概览
简要总结
In the DEMAND pilot study, we will recruit and randomize 80 participants at two study sites (Umeå and Uppsala) for a one-year intervention. The primary objectives are to study the inclusion rate, the adherence rate, and the acceptability of the intervention. The secondary objectives are to examine the effect of the intervention on intermediate outcomes, including metabolic control (i.e., blood glucose and lipids), body weight, blood pressure, physical fitness, and cognitive function. Third, the investigators will perform focus group interviews to explore the participants views on the intervention to assess the acceptability. The interventions include (a) Mediterranean diet (b) an individualized physical training program and (c) pharmacological treatment for type 2 diabetes (T2D) aimed to achieve individualized optimal goals, according to national guidelines, taking into account the risk of hypoglycaemia. This multi-component intervention is more comprehensive than usual care, and it specifically focuses on vascular domains.
详细描述
To be inserted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes diagnosed in the last year
- •age >=65 years
- •signed consent form
- •Mild cognitive impairment
排除标准
- •diagnosis type 1 diabetes
- •major neurocognitive degeneration
- •serious illness with live expectancy less than 3 years
- •drug- or alcohol-abuse or other neurological / psychiatric illness which affects the outcome
- •depressive syndrome
- •predicted inability to conduct the study because of drug abuse, serious illness, language issues
- •documented episodes of hypoglycemia where help of a third part was needed
- •Allergy to fish or nuts
- •Angina pectoris
- •Heart failure (NYHA 3-4)
研究组 & 干预措施
group of intervention
participants receive
- personalized advice of a dietician about mediterranean diet
- individualized training program,
- recommendation about optimized pharmacological treatment as in high risk groups for cardiovascular diseases
干预措施: recommended modified pharmacological treatment (Other)
group of intervention
participants receive
- personalized advice of a dietician about mediterranean diet
- individualized training program,
- recommendation about optimized pharmacological treatment as in high risk groups for cardiovascular diseases
干预措施: mediterranean diet (Dietary Supplement)
group of intervention
participants receive
- personalized advice of a dietician about mediterranean diet
- individualized training program,
- recommendation about optimized pharmacological treatment as in high risk groups for cardiovascular diseases
干预措施: individualized fitness program (Behavioral)
group of control
participants receive
- written information about the advantages of a healthy diet
- written information about the advantages of physical activity,
- medical treatment according to the latest version of the national guidelines issued by the Swedish Medical Product Agency
结局指标
主要结局
inclusion rate
时间窗: 4 months
How many subjects (n) will be randomized within four months?
adherence rate
时间窗: 1 year
What is the proportion (%) of subjects in the intervention group who will adhere to 90% of the diet, exercise and medical intervention?
retention rate
时间窗: 1 year
What is the proportion of drop-out in the two groups?
次要结局
- Metabolic change(1 year)
- Memory function(1 year)