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

NCT ID: NCT03877783

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-19
• Study Completion Date: 2023-06-30

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.

Conditions

Type 2 Diabetes Mellitus; Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

group of intervention

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 Type: EXPERIMENTAL

mediterranean diet

Intervention Type: DIETARY_SUPPLEMENT

The recommended Mediterranean diet is based on lean meat, fish, eggs, vegetables, fruits, berries, and nuts. Extra-virgin olive oil is the recommended additional fat source for use in food preparation and dressings. Recommended exclusions or restrictions include dairy products, cereals, added salt, refined fats, and sugar. Participants in the intervention group will receive weekly deliveries of olive oil and mixed nuts, free of cost, and they will receive recipes for Mediterranean meals on a regular basis. During the study, the intervention group will receive written, personalized advice from a project dietician on how to improve their Mediterranean diets. This written personalized advice will be based on the reported food intake, its coherence with a Mediterranean diet, and its adherence to the recommended intakes of energy and nutrients for each participant.

individualized fitness program

Intervention Type: BEHAVIORAL

The exercise intervention will consist of individualized training programs designed to improve cardiovascular fitness (VO2). A personal trainer will distribute the training program instructions and monitor the training during the entire intervention. Support will be provided via text messages. The training intensity will be based on results from an extensive pre-test of individual physical fitness performance, and we will adjust the intensity over the study period, as fitness improves. The goal is to engage participants in training three times per week, for up to one hour per training session. The individualized training programs will consist of brisk walks, jogging, and cycling, tailored to each participant. To ensure that the training intensity is sufficient to improve cardiovascular fitness, heart rate will be monitored during each session.

recommended modified pharmacological treatment

Intervention Type: OTHER

Hyperglycemia: first metformin till target level of HbA1c 1) 53-58 mmol/mol for patients with ≤2 coexisting chronic illnesses or 2) 59-64 mmol/mol for those with established cardiovascular disease (CVD). We will recommend a second glucose-lowering drug when HbA1c is not achieved and which reduce CVD even when the participant does not have a manifest CVD.

Hypertension: will be treated to achieve a target level according to European guidelines. Start with a combination of a renin-angiotensin system (RAS)-blocker and a thiazide in low dose or a combination of a RAS-blocker a calcium channel blocker in low dose. If the target is not reached within 12 weeks additional drugs should be added.

Dyslipidemia: Patients with a CVD risk of 2-8% within 5 years should receive treatment with atorvastatin 10mg +ezetimib 10mg; CVD risk 8-20%, atorvastatin 20mg + ezetimib 10mg and CVD risk > 20% atorvastatin 40-80mg +ezetimib 10mg.

group of control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

mediterranean diet

The recommended Mediterranean diet is based on lean meat, fish, eggs, vegetables, fruits, berries, and nuts. Extra-virgin olive oil is the recommended additional fat source for use in food preparation and dressings. Recommended exclusions or restrictions include dairy products, cereals, added salt, refined fats, and sugar. Participants in the intervention group will receive weekly deliveries of olive oil and mixed nuts, free of cost, and they will receive recipes for Mediterranean meals on a regular basis. During the study, the intervention group will receive written, personalized advice from a project dietician on how to improve their Mediterranean diets. This written personalized advice will be based on the reported food intake, its coherence with a Mediterranean diet, and its adherence to the recommended intakes of energy and nutrients for each participant.

Intervention Type: DIETARY_SUPPLEMENT

individualized fitness program

The exercise intervention will consist of individualized training programs designed to improve cardiovascular fitness (VO2). A personal trainer will distribute the training program instructions and monitor the training during the entire intervention. Support will be provided via text messages. The training intensity will be based on results from an extensive pre-test of individual physical fitness performance, and we will adjust the intensity over the study period, as fitness improves. The goal is to engage participants in training three times per week, for up to one hour per training session. The individualized training programs will consist of brisk walks, jogging, and cycling, tailored to each participant. To ensure that the training intensity is sufficient to improve cardiovascular fitness, heart rate will be monitored during each session.

Intervention Type: BEHAVIORAL

recommended modified pharmacological treatment

Hyperglycemia: first metformin till target level of HbA1c 1) 53-58 mmol/mol for patients with ≤2 coexisting chronic illnesses or 2) 59-64 mmol/mol for those with established cardiovascular disease (CVD). We will recommend a second glucose-lowering drug when HbA1c is not achieved and which reduce CVD even when the participant does not have a manifest CVD.

Hypertension: will be treated to achieve a target level according to European guidelines. Start with a combination of a renin-angiotensin system (RAS)-blocker and a thiazide in low dose or a combination of a RAS-blocker a calcium channel blocker in low dose. If the target is not reached within 12 weeks additional drugs should be added.

Dyslipidemia: Patients with a CVD risk of 2-8% within 5 years should receive treatment with atorvastatin 10mg +ezetimib 10mg; CVD risk 8-20%, atorvastatin 20mg + ezetimib 10mg and CVD risk > 20% atorvastatin 40-80mg +ezetimib 10mg.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Olov Rolandsson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olov Rolandsson, Professor

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

Umeå University

Umeå, Västerbotten County, Sweden

Countries

Sweden

Other Identifiers

DEMAND pilot

Identifier Type: -

Identifier Source: org_study_id