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Diabetes Mellitus, Type 2, Cognitive Dysfunction, Epigenetics, ExerciseNCT04603885

Using Polar Unite Fitness Watch to Improve Cognition for T2DM Patients

A study testing Aerobic exercise program and Stretching exercise in people with Diabetes Mellitus, Type 2, Cognitive Dysfunction, Epigenetics, Exercise, run by University of Arkansas, Fayetteville.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Type 2 diabetes mellitus (T2DM) impairs the brain, leading to cognitive dysfunction, which carries substantial lifetime consequences. This highlights an urgent need to find effective therapeutic strategies to improve cognitive function among those with T2DM. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Aerobic exercise program and Stretching exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
No sites listed yet
Study dates
27 Oct 2020to 15 Jul 2021
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants eligible for this study will be physically inactive adults with no major chronic physical or mental disorders but classified as having low physical activity levels determined by the International Physical Activity Questionnaire. Participants must have a documented medical diagnosis of T2DM and must be receiving diabetes care at the time of enrollment. Participants must be English-speaking and are able to give informed consent.

Who cannot join

  • Exclusion criteria include uncontrolled hypertension with resting blood pressure of 160/90 mmHg or higher, having symptoms of coronary ischemia such as chest pain and severe shortness of breath during activities of daily living, loss of consciousness/fainting for any reason, or having any other medical or physical conditions that may interfere with exercise participation.

Trial locations and contacts

No sites are listed yet.

Tingting Liu, PhD contact

4795755038

tl023@uark.edu

About this study

Official title: Feasibility Testing a Randomized Controlled Trial of an mHealth-enhanced Exercise Program to Improve Cognition for T2DM Patients

Type 2 diabetes mellitus (T2DM) impairs the brain, leading to cognitive dysfunction, which carries substantial lifetime consequences. This highlights an urgent need to find effective therapeutic strategies to improve cognitive function among those with T2DM. Aerobic exercise enhances cognitive function among healthy subjects through increased release of BDNF. BDNF supports survival of existing neurons and promotes growth of new neurons and synapses. Emerging evidence suggests that reduced BDNF levels may exacerbate cognitive dysfunction associated with T2DM. Compared to drug delivery of BDNF, aerobic exercise is a low-cost, safe, and easily accessible path to increasing endogenous BDNF levels. One critical genetic variant that affects BDNF secretion and cognition is the BDNF Val66Met variant, which is a common missense polymorphism that results in a valine (Val) to methionine (Met) substitution at codon 66 located in exon IX of the BDNF gene. The Met allele alters intracellular processing, trafficking, packaging of pro-BDNF, and consequently interferes with the activity-dependent secretion of mature BDNF among Met carriers. In addition, previous research reported an influence of the Val66Met variant on the methylation level of the surrounding region. Carrying a G nucleotide (i.e., Val allele) will have an additional CpG site, and Val/Val homozygotes demonstrated a significant increase in methylation levels of four nearby CpG sites compared to Val/Met heterozygotes and Met/Met homozygotes. Because high BDNF gene methylation is associated with reduced BDNF mRNA levels, this may result in lower BDNF levels among Val/Val carriers. However, the transcription of promoter IV can be initiated by exercise, suggesting that epigenetic modulation of BDNF gene expression may be achieved by exercise. It is plausible that exercise may partly reverse transcriptional repression through dynamic DNA demethylation, but the interaction between DNA demethylation and Val homozygosity may be different from that in Met/Met and in Val/Met carriers, which could explain interpersonal differences in cognitive outcomes among these carriers following exercise training. So far, the evidence on the interplay of the Val66Met polymorphism, DNA methylation, and exercise on cognition among individuals with T2DM is still lacking. A total of 42 participants with T2DM will be randomized 2:1 to receive aerobic exercise intervention (n=28) or attention control (n=14) for 3 months. Both groups will receive weekly phone calls during the intervention and standard printed education materials regarding diabetes self-management. In addition to these interventions, the aerobic exercise group (i.e., experimental group) will also perform home-based walking exercise, while the attention control group will perform home-based stretching exercise. Trained students will monitor the exercise sessions for both groups at the Connected Health Platform (hereafter referred to as "platform"). Blood samples will be collected at baseline and three months. Outcomes of interest include post-intervention changes in plasma BDNF levels, BDNF DNA methylation executive function, memory, and processing speed. The study will evaluate the feasibility of the home-based exercise intervention. The study will also evaluate preliminary effectiveness of the supervised exercise program on of the exercise program on BDNF DNA demethylation. An exploratory aim is to explore the association of DNA demethylation with plasma BDNF levels and cognition.

Being tested
Aerobic exercise program, Stretching exercise
Medical subject headings
Diabetes Mellitus, Cognitive Dysfunction, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic exercise programBehavioural

    A randomized controlled trial will be used to test the feasibility of a home-based exercise program to improve BDNF DNA demethylation among individuals with T2DM. A total of 42 participants will be randomized 2:1 to receive aerobic exercise intervention (n=28) or attention control (n=14) for 3 months. This ratio is used to offset an anticipated attrition imbalance across groups.

  • Stretching exerciseBehavioural

    stretching exercise

Study groups in NCT04603885
Study groupRoleWhat they receive
Aerobic exercise groupExperimentalAerobic exercise will be measured with a Polar United fitness watch. Heart rate during exercise will be measured using a Polar United fitness watch, which has been validated for monitoring moderate and high intensity physical activity.
Receives: Behavioral: Aerobic exercise program
Attention control groupPlacebo comparatorThe time-equivalent, stretching movements will serve as the placebo exercise condition in this proposed study. Previous research has shown that stretching could reduce attrition and patient dissatisfaction and better ensure allocation concealment. Following baseline measures, a student will demonstrate the use of a Polar United fitness watch and stretching movements via zoom from week 3 to week 5. Starting on week 3, participants will perform the prescribed stretching exercise 3 times a week, maintaining heart rate below 40% of heart rate reserve during exercise.
Receives: Behavioral: Stretching exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BDNF DNA demethylation in percentage

    Measured: Three months

Secondary outcomes (5)
  1. Plasma BDNF levels in ng

    Measured: Three months

  2. Executive function

    Executive function will be measured by the Dimensional Change Card Sort Test. Test-retest reliability of the test is 0.88. Convergent validity and discriminant validity is -0.51 and 0.14, respectively.

    Measured: Three months

  3. Episodic memory

    Episodic memory will be measured by the Picture Sequence Memory Test. Test-retest reliability of the test is 0.77. Convergent validity and discriminant validity is 0.69 and -0.08, respectively.

    Measured: Three months

  4. Working memory

    Working memory will be measured by the List Sorting Working Memory Test. Test-retest reliability of the test is 0.77. Convergent validity and discriminant validity are 0.58 and 0.30, respectively.

    Measured: Three months

  5. Processing speed

    Processing speed will be measured by the Pattern Comparison Processing Speed Test. The test takes about 3 minutes to compete. Test-retest reliability of the test is 0.72. Convergent validity and discriminant validity is 0.49 and 0.12, respectively.

    Measured: Three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2020
  2. Study start27 Oct 2020 (estimated)
  3. Primary completion15 May 2021 (estimated)
  4. Study completion15 Jul 2021 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04603885
Sponsor's protocol ID
2009284124
Status last verified
Oct 2020
First submitted
21 Oct 2020
Last updated
27 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic exercise program and Stretching exercise in people with Diabetes Mellitus, Type 2, Cognitive Dysfunction, Epigenetics, Exercise, run by University of Arkansas, Fayetteville.

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 1 inclusion and 1 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 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Contact Tingting Liu, PhD (4795755038, tl023@uark.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BDNF DNA demethylation in percentage (time frame: Three months). 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 27 Oct 2020.

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