Diet, physical exercise, and metabolic control intervention to reduce the incidence of major neurocognitive disorders among individuals with type 2 diabetes combined with mild neurocognitive impairment – a pilot study - DEMAND-pilot

meå University0 个研究点目标入组 80 人开始时间: 2019年11月4日最近更新: 2020年2月1日

适应症

试验速览

暂无简介。

•(i)Diagnosis of T2D according to WHO criteria
•(ii)HbA1c =48 – 79 mmol/mol
•(iii)Mild NCD (defined by DSM-5 criteria) *
•(iv)=65 years of age of both sexes
•(v)Provide written, informed consent
•*1)Concern of the individual, a knowledgeable informant, or the clinician that there has been a mild decline in cognitive function; and 2) A modest impairment in cognitive performance preferably documented by standardized neuropsychological testing; in this study we will use a standardized test of delayed recall.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•(i)HbA1c = 80 mmol/mol
•(ii)Known or suspected other form of diabetes than type 2
•(iii)Major NCD (i.e. dementia) in EHR.
•(iv)Serious illness associated with a short life expectancy (<3 years)
•(v)Alcohol/drug abuse or other major neurological or psychiatric disorder that might affect the primary outcome;
•(vi)Depression (Geriatric Depression Scale-15: >10)
•(vii)Predicted inability to comply with the study protocol, due to, e.g., drug abuse, serious psychiatric disorder, severe mobility impairment, or inability to communicate in the Swedish language
•(viii)Documented episodes of severe hypoglycemia (i.e. required assistance from another person)
•(ix)Severe kidney failure: eGFR < 30 ml/min/1.73m2
•(x)Dementia: MMSE <24 at screening or 6 mo visit
•(xi)Systolic blood pressure ?200 mmHg and/or diastolic blood pressure ?115 mmHg
•(xii)Anemia (Haemoglobin: Men <120 g/L; Women <110 g/L)
•(xiii)Heart failure (NYHA =3)
•(xiv)Known angina pectoris
•(xv)Potential severe heart disease (e.g. severe arrhythmia)
•(xvi)Nut allergies
•(xvii)Fish allergy
•(xviii)Ongoing participation in another clinical trial

发起方

meå University