- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03877783
DEMAND - Multifactorial Study to Reduce Dementia in People With Type 2 Diabetes (DEMAND)
Diet, Physical Exercise and Metabolic Control (DEMAND) Intervention to Reduce the Incidence of Major Neurocognitive Disorders Among Individuals With Type 2 Diabetes Combined With Mild Neurocognitive Impairment - a Pilot Study
Study Overview
Status
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Västerbotten
-
Umeå, Västerbotten, Sweden, 90185
- Umea University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: group of intervention
participants receive
|
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.
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.
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. |
NO_INTERVENTION: group of control
participants receive
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
inclusion rate
Time Frame: 4 months
|
How many subjects (n) will be randomized within four months?
|
4 months
|
adherence rate
Time Frame: 1 year
|
What is the proportion (%) of subjects in the intervention group who will adhere to 90% of the diet, exercise and medical intervention?
|
1 year
|
retention rate
Time Frame: 1 year
|
What is the proportion of drop-out in the two groups?
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic change
Time Frame: 1 year
|
Is there a significant decrease in HbA1c, blood pressure, and blood lipids in the intervention group compared to the control group?
|
1 year
|
Memory function
Time Frame: 1 year
|
Is the decline in memory function lower in the intervention froup compared to the control group?
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olov Rolandsson, Professor, Umea University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DEMAND pilot
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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