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 sites80 target enrollmentNovember 4, 2019

Overview

No summary available.

Registry

who.int

Start Date

November 4, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

meå University

•(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

•(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