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

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003772-39-SE

Enrollment

Registered

2019-11-04

Start date

2019-12-13

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

Pharmaceutical Form: Tablet Pharmaceutical Form: Tablet Pharmaceutical Form: Tablet Pharmaceutical Form: Tablet Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (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

Exclusion criteria

Exclusion criteria: (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 (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

Design outcomes

Primary

Measure	Time frame
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.; Primary end point(s): Feasibility: 1. Recruitment rate 2. Retention rate 3. Adherence rate 4. Acceptance rate ; Timepoint(s) of evaluation of this end point: 1. After study completion 2. After study completion 3. At 0, 6 and 12 months 4. Between 6 weeks after study start and the 6-month visit, and at the end of the study.	—

Measure

Time frame

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.; Primary end point(s): Feasibility: 1. Recruitment rate 2. Retention rate 3. Adherence rate 4. Acceptance rate ; Timepoint(s) of evaluation of this end point: 1. After study completion 2. After study completion 3. At 0, 6 and 12 months 4. Between 6 weeks after study start and the 6-month visit, and at the end of the study.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Metabolic control: Blood levels of HbA1c and lipids, height, body weight, BMI and waist circumference. 2. Metabolic control: Blood pressure. 3. Estimated food intake: Recorded intake of approximately 20 food items over 4 consecutive days. 4. Cardiovascular fitness: Aerobic capacity (VO2max) estimated with the Ekblom-Bak test. 5. Physical activity and sedentary behavior: The accelerometer activPAL will be used to measure physical activity and sedentary behavior. 6. Grip strength: Grip strength in the left and right hand measured with a hand dynamometer. 7. Leg strength: Functional leg strength and endurance measured using the Chair Stand Test. 8. Exercise Self-Efficacy Scale (ESES): To investigate participants self-efficacy regarding performing exercise. 9. Exercise Regulations Questionnaire (BREQ-2): To investigate participants motivation to exercise. 10. Cognitive function: Evaluated with standardized neuropsychological tests. ; Timepoint(s) of evaluation of this end point: 1. At 0, 6 and 12 months. 2. At 0, 3, 6, 9 and 12 months. 3. At 0, 6 and 12 months. 4. At 0, 6 and 12 months. 5. At 0, 6 and 12 months. 6. At 0, 6 and 12 months. 7. At 0, 6 and 12 months. 8. At 0, 6 and 12 months. 9. At 0, 6 and 12 months. 10. At 0 and 12 months	—

Measure

Time frame

Secondary end point(s): 1. Metabolic control: Blood levels of HbA1c and lipids, height, body weight, BMI and waist circumference. 2. Metabolic control: Blood pressure. 3. Estimated food intake: Recorded intake of approximately 20 food items over 4 consecutive days. 4. Cardiovascular fitness: Aerobic capacity (VO2max) estimated with the Ekblom-Bak test. 5. Physical activity and sedentary behavior: The accelerometer activPAL will be used to measure physical activity and sedentary behavior. 6. Grip strength: Grip strength in the left and right hand measured with a hand dynamometer. 7. Leg strength: Functional leg strength and endurance measured using the Chair Stand Test. 8. Exercise Self-Efficacy Scale (ESES): To investigate participants self-efficacy regarding performing exercise. 9. Exercise Regulations Questionnaire (BREQ-2): To investigate participants motivation to exercise. 10. Cognitive function: Evaluated with standardized neuropsychological tests. ; Timepoint(s) of evaluation of this end point: 1. At 0, 6 and 12 months. 2. At 0, 3, 6, 9 and 12 months. 3. At 0, 6 and 12 months. 4. At 0, 6 and 12 months. 5. At 0, 6 and 12 months. 6. At 0, 6 and 12 months. 7. At 0, 6 and 12 months. 8. At 0, 6 and 12 months. 9. At 0, 6 and 12 months. 10. At 0 and 12 months

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Countries

Sweden

Contacts

Public ContactOlov Rolandsson

Umeå University

olov.rolandsson@umu.se+46705902052

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026