Type 2 Diabetes MellitusDEMANDNCT03877783
DEMAND - Multifactorial Study to Reduce Dementia in People With Type 2 Diabetes
A study testing mediterranean diet, individualized fitness program and recommended modified pharmacological treatment in people with Type 2 Diabetes Mellitus and Mild Cognitive Impairment, run by Umeå University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Mild Cognitive Impairment
- What is being tested?
- mediterranean diet, individualized fitness program and recommended modified pharmacological treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 19 Oct 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- type 2 diabetes diagnosed in the last year
- age >=65 years
- signed consent form
- Mild cognitive impairment
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
To be inserted.
- Being tested
- mediterranean diet, individualized fitness program, recommended modified pharmacological treatment
- Keywords
- mediterranean diet, physical fitness
- Medical subject headings
- Diabetes Mellitus, Type 2, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mediterranean dietDietary 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 programBehavioural
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 treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| group of intervention | Experimental | 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 Receives: Dietary Supplement: mediterranean diet; Behavioral: individualized fitness program; Other: recommended modified pharmacological treatment |
| group of control | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
inclusion rate
How many subjects (n) will be randomized within four months?
Measured: 4 months
adherence rate
What is the proportion (%) of subjects in the intervention group who will adhere to 90% of the diet, exercise and medical intervention?
Measured: 1 year
retention rate
What is the proportion of drop-out in the two groups?
Measured: 1 year
Secondary outcomes (2)
Metabolic change
Is there a significant decrease in HbA1c, blood pressure, and blood lipids in the intervention group compared to the control group?
Measured: 1 year
Memory function
Is the decline in memory function lower in the intervention froup compared to the control group?
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start19 Oct 2020
- Primary completion31 Mar 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olov Rolandsson, Umeå University
- Investigators
- Olov Rolandsson, Professor, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877783
- Sponsor's protocol ID
- DEMAND pilot
- Acronym
- DEMAND
- Status last verified
- Mar 2021
- First submitted
- 8 Feb 2019
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03877783
- Acronym / sponsor ID
- DEMAND / DEMAND pilot
- Keywords
- mediterranean diet, physical fitness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group of intervention | Experimental | Dietary Supplement: mediterranean diet, Behavioral: individualized fitness program, Other: recommended modified pharmacological treatmentparticipants 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 control | No intervention | –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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- type 2 diabetes diagnosed in the last year
- age >=65 years
- signed consent form
- Mild cognitive impairment
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mediterranean dietThe 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. | Dietary supplement | group of intervention |
| individualized fitness programThe 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. | Behavioural | group of intervention |
| recommended modified pharmacological treatmentHyperglycemia: 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. | Other | group of intervention |
Primary outcome
inclusion rate
Time frame: 4 months
How many subjects (n) will be randomized within four 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?
retention rate
Time frame: 1 year
What is the proportion of drop-out in the two groups?
2 secondary outcomes
Metabolic change
Time frame: 1 year
Memory function
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olov Rolandsson, Professor principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mediterranean diet, individualized fitness program and recommended modified pharmacological treatment in people with Type 2 Diabetes Mellitus and Mild Cognitive Impairment, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inclusion rate (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.