Diabetes Mellitus, Type 2NCT04590833
Feasibility Testing an Exercise Program to Improve Cognition for T2DM Patients
A study testing Supervised walking on a treadmill and Supervised stretching exercise in people with Diabetes Mellitus, Type 2, run by Florida State University at 1 site in United States.
Trial summary
This proposed study will advance science by providing evidence on the feasibility of a standardized, rigorously designed and delivered exercise program to improve cognition and plasma brain-derived neurotrophic factor (BDNF) levels for individuals with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Supervised walking on a treadmill and Supervised stretching exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 15 Dec 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 sedentary 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
- 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 (such as osteoporosis, asthma, spinal cord injury) or symptoms (e.g., pain or swelling in any part of the body) that may interfere with exercise participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas
Fayetteville, Arkansas, 72701
About this study
Official title: Feasibility Testing a Randomized Controlled Trial of an Exercise Program to Improve Cognition for T2DM Patients
This proposed study will advance science by providing evidence on the feasibility of a standardized, rigorously designed and delivered exercise program to improve cognition and plasma brain-derived neurotrophic factor (BDNF) levels for individuals with type 2 diabetes. We will also explore how certain genetic variant may influence exercise-induced cognitive improvements and plasma BDNF levels. Findings of the proposed study will establish a comprehensive knowledge base for future research and development of a personalized exercise program for high-risk individuals who are vulnerable to cognitive dysfunction based on their genomic profiles.
Read the detailed description
The study will pilot-test a 3-month supervised exercise program to improve plasma brain-derived neurotrophic factor (BDNF) levels and domains of cognition that are mostly affected in type 2 diabetes mellitus (T2DM), including memory, processing speed, and executive function, overall and according to genotypes of the BDNF Val66Met variant. 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. In persons with T2DM, integrity of the blood-brain barrier (BBB) is impaired. Although a growing body of evidence supports the protective role of regular exercise in BBB integrity, very little is known about how resting peripheral BDNF levels may change in response to regular aerobic exercise training after adjusting for BBB permeability among individuals with T2DM. One critical genetic variant that affects cognition in human is the BDNF Val66Met variant. The Met allele interferes with the activity-dependent secretion of mature BDNF among Met carriers. Despite the strong evidence suggesting aerobic exercise has a beneficial effect on cognitive function, significant variability in individual response to exercise training in cognitive outcomes has been reported among Val/Val vs. Met carriers. However, the evidence on how the BDNF Val66Met variant influences cognitive outcomes following an aerobic exercise intervention among individuals with T2DM is currently lacking. A total of 84 participants with T2DM will be randomized 2:1 to receive aerobic exercise intervention (n=56) or attention control (n=28) for 3 months. The study will evaluate the feasibility of the intervention. The study will also evaluate preliminary effectiveness of the supervised exercise program on cognitive function and plasma BDNF levels after controlling BBB permeability. An exploratory aim is to explore the influence of the BDNF Val66Met polymorphism on cognitive outcomes and plasma BDNF levels in response to aerobic exercise intervention. The purpose of this study is well aligned with the National Institute of Nursing Research (NINR) mission to develop personalized interventions that address mechanisms underlying symptoms of illness through symptom science research. Based on the findings of this proposed study, our long-term goal is to develop a personalized exercise program for high-risk individuals susceptible to cognitive dysfunction based on their genomic profiles.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Supervised walking on a treadmill, Supervised stretching exercise
- Keywords
- cognitive dysfunction, exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised walking on a treadmillBehavioural
Each participant will be provided with an individualized target heart rate zone based on his/her age. Heart rate during exercise will be measured using a finger pulse oximeter. Following baseline measures, participants will receive instructions on how to use a finger pulse oximeter by a student. For participants who are not physically fit or are just engaging in regular exercise, they will be advised to start walking on a treadmill at a comfortable pace for 5 to 10 minutes at one time.46 Exercise duration and intensity will be progressed from week 3 to week 5, until participants will walk at 40-59% of heart rate reserve based on their age, which will be maintained throughout the study.
Supervised stretching exerciseBehavioural
Following baseline measures, a student will demonstrate the use of a pulse oximeter and stretching movements to these participants. Starting on week 3, participants will do the prescribed stretching exercise 3 times a week, maintaining heart rate below 40% of heart rate reserve during exercise. Stretching will target all major muscle-tendon groups including shoulder, chest, neck, truck, lower back, hips, and legs. It will also involve a slow and constant motion that accounts for any physical limitations and physician-specified precautions
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise group | Experimental | Not described Receives: Behavioral: Supervised walking on a treadmill |
| Attention control group | Placebo comparator | Not described Receives: Behavioral: Supervised stretching exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodic memory
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
Executive function
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
Working memory
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
Processing speed
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
Secondary outcomes (6)
Plasma BDNF in ng/mL
BDNF in plasma will be measured using an ELISA kit.
Measured: Three months
Fasting blood glucose in mg/dL
Fasting blood glucose will be measured using YSI.
Measured: Three months
HbA1c in percentage
HbA1c will be measured using an ELISA kit.
Measured: Three months
Weight in kilograms
Weight will be measured with a health scale.
Measured: Three months
Height in meters
Height will be measured using a stadiometer.
Measured: Three months
BMI
weight and height will be combined to report BMI in kg/m^2
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Jun 2021
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Why it stopped: The NIH Grant was terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arkansas, Fayetteville
- Responsible party
- Principal investigator, Tingting Liu, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590833
- Sponsor's protocol ID
- 2005265810
- Status last verified
- Aug 2026
- First submitted
- 9 Oct 2020
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Testing a Randomized Controlled Trial of an Exercise Program to Improve Cognition for T2DM Patients
- ClinicalTrials.gov ID
- NCT04590833
- Acronym / sponsor ID
- 2005265810
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- cognitive dysfunction, exercise
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The NIH Grant was terminated
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- University of Arkansas, Fayetteville
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 19 Oct 2020 (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.
This proposed study will advance science by providing evidence on the feasibility of a standardized, rigorously designed and delivered exercise program to improve cognition and plasma brain-derived neurotrophic factor (BDNF) levels for individuals with type 2 diabetes. We will also explore how certain genetic variant may influence exercise-induced cognitive improvements and plasma BDNF levels. Findings of the proposed study will establish a comprehensive knowledge base for future research and development of a personalized exercise program for high-risk individuals who are vulnerable to cognitive dysfunction based on their genomic profiles.
Detailed description
The study will pilot-test a 3-month supervised exercise program to improve plasma brain-derived neurotrophic factor (BDNF) levels and domains of cognition that are mostly affected in type 2 diabetes mellitus (T2DM), including memory, processing speed, and executive function, overall and according to genotypes of the BDNF Val66Met variant. 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. In persons with T2DM, integrity of the blood-brain barrier (BBB) is impaired. Although a growing body of evidence supports the protective role of regular exercise in BBB integrity, very little is known about how resting peripheral BDNF levels may change in response to regular aerobic exercise training after adjusting for BBB permeability among individuals with T2DM. One critical genetic variant that affects cognition in human is the BDNF Val66Met variant. The Met allele interferes with the activity-dependent secretion of mature BDNF among Met carriers. Despite the strong evidence suggesting aerobic exercise has a beneficial effect on cognitive function, significant variability in individual response to exercise training in cognitive outcomes has been reported among Val/Val vs. Met carriers. However, the evidence on how the BDNF Val66Met variant influences cognitive outcomes following an aerobic exercise intervention among individuals with T2DM is currently lacking. A total of 84 participants with T2DM will be randomized 2:1 to receive aerobic exercise intervention (n=56) or attention control (n=28) for 3 months. The study will evaluate the feasibility of the intervention. The study will also evaluate preliminary effectiveness of the supervised exercise program on cognitive function and plasma BDNF levels after controlling BBB permeability. An exploratory aim is to explore the influence of the BDNF Val66Met polymorphism on cognitive outcomes and plasma BDNF levels in response to aerobic exercise intervention. The purpose of this study is well aligned with the National Institute of Nursing Research (NINR) mission to develop personalized interventions that address mechanisms underlying symptoms of illness through symptom science research. Based on the findings of this proposed study, our long-term goal is to develop a personalized exercise program for high-risk individuals susceptible to cognitive dysfunction based on their genomic profiles.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise group | Experimental | Behavioral: Supervised walking on a treadmill |
| Attention control group | Placebo comparator | Behavioral: Supervised stretching exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants eligible for this study will be sedentary 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.
Key exclusion criteria (1 listed)
- 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 (such as osteoporosis, asthma, spinal cord injury) or symptoms (e.g., pain or swelling in any part of the body) that may interfere with exercise participation.
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 |
|---|---|---|
| Supervised walking on a treadmillEach participant will be provided with an individualized target heart rate zone based on his/her age. Heart rate during exercise will be measured using a finger pulse oximeter. Following baseline measures, participants will receive instructions on how to use a finger pulse oximeter by a student. For participants who are not physically fit or are just engaging in regular exercise, they will be advised to start walking on a treadmill at a comfortable pace for 5 to 10 minutes at one time.46 Exercise duration and intensity will be progressed from week 3 to week 5, until participants will walk at 40-59% of heart rate reserve based on their age, which will be maintained throughout the study. | Behavioural | Aerobic exercise group |
| Supervised stretching exerciseFollowing baseline measures, a student will demonstrate the use of a pulse oximeter and stretching movements to these participants. Starting on week 3, participants will do the prescribed stretching exercise 3 times a week, maintaining heart rate below 40% of heart rate reserve during exercise. Stretching will target all major muscle-tendon groups including shoulder, chest, neck, truck, lower back, hips, and legs. It will also involve a slow and constant motion that accounts for any physical limitations and physician-specified precautions | Behavioural | Attention control group |
Primary outcome
Episodic memory
Time frame: Three months
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.
Executive function
Time frame: Three months
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.
Working memory
Time frame: Three months
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.
Processing speed
Time frame: Three months
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.
6 secondary outcomes
Plasma BDNF in ng/mL
Time frame: Three months
Fasting blood glucose in mg/dL
Time frame: Three months
HbA1c in percentage
Time frame: Three months
Weight in kilograms
Time frame: Three months
Height in meters
Time frame: Three months
BMI
Time frame: Three months
Results and safety
The study was stopped early (reason given: The NIH Grant was terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised walking on a treadmill and Supervised stretching exercise in people with Diabetes Mellitus, Type 2, run by Florida State University at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 17 Aug 2026. 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 United States. 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. 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?
The study was stopped early (reason given: The NIH Grant was terminated). 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?
Episodic memory (time frame: Three months). The study lists 4 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 17 Aug 2026.