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

Not Applicable

• Conditions: Mild Cognitive Impairment; Type 2 Diabetes Mellitus
• Interventions: Dietary Supplement: mediterranean diet; Behavioral: individualized fitness program; Other: recommended modified pharmacological treatment

• Registration Number: NCT03877783
• Lead Sponsor: Umeå University

Brief Summary

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.

Detailed Description

To be inserted.

Study Timeline

• Study First Submitted: 2019-02-08
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-18
• Study Start: 2020-10-19
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-25
• Last Update Posted: 2021-03-26
• Primary Completion: 2022-03-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group of intervention	individualized fitness program	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
group of intervention	mediterranean diet	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
group of intervention	recommended modified pharmacological treatment	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

Primary Outcome Measures

Name	Time	Method
inclusion rate	4 months	How many subjects (n) will be randomized within four months?
adherence rate	1 year	What is the proportion (%) of subjects in the intervention group who will adhere to 90% of the diet, exercise and medical intervention?
retention rate	1 year	What is the proportion of drop-out in the two groups?

Secondary Outcome Measures

Name	Time	Method
Memory function	1 year	Is the decline in memory function lower in the intervention froup compared to the control group?
Metabolic change	1 year	Is there a significant decrease in HbA1c, blood pressure, and blood lipids in the intervention group compared to the control group?

Trial Locations

Locations (1)

Umeå University; 🇸🇪 Umeå, Västerbotten, Sweden