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
- Conditions
- Type 2 diabetesTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2019-003772-39-SE
- Lead Sponsor
- meå University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 80
(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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether the chosen study design is feasible in terms of recruitment, retainment, adherence, and acceptance.;Secondary Objective: 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.;<br> Primary end point(s): Feasibility:<br> 1. Recruitment rate<br> 2. Retention rate<br> 3. Adherence rate<br> 4. Acceptance rate<br> ;<br> Timepoint(s) of evaluation of this end point: 1. After study completion<br> 2. After study completion<br> 3. At 0, 6 and 12 months<br> 4. Between 6 weeks after study start and the 6-month visit, and at the end of the study.<br>
- Secondary Outcome Measures
Name Time Method