DEMAND - Multifactorial Study to Reduce Dementia in People With Type 2 Diabetes

Umeå University

Status: Unknown

Conditions: Mild Cognitive Impairment; Type 2 Diabetes Mellitus

Treatments: Other: recommended modified pharmacological treatment; Behavioral: individualized fitness program; Dietary Supplement: mediterranean diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03877783

DEMAND pilot

Details and patient eligibility

About

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.

Full description

To be inserted.

Enrollment: 10 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• type 2 diabetes diagnosed in the last year
• age >=65 years
• signed consent form
• Mild cognitive impairment

Exclusion criteria

• 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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups

group of intervention

Experimental group

Description:

participants receive 1. personalized advice of a dietician about mediterranean diet 2. individualized training program, 3. recommendation about optimized pharmacological treatment as in high risk groups for cardiovascular diseases

Treatment:

Behavioral: individualized fitness program

Other: recommended modified pharmacological treatment

Dietary Supplement: mediterranean diet

group of control

No Intervention group

Description:

participants receive 1. written information about the advantages of a healthy diet 2. written information about the advantages of physical activity, 3. medical treatment according to the latest version of the national guidelines issued by the Swedish Medical Product Agency