Type 2 Diabetes MellitusNCT04489966
Effects of Aerobic Training on Pancreatic Fat and Cognitive Function in T2DM Patients
A study testing Aerobic training in people with Type 2 Diabetes Mellitus, run by Nanjing University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The primary aim of this study was to evaluate the difference in cognitive function and brain functional structure between exercise group and control group by performing regular one-year moderate-intensity aerobic training in type 2 diabetes mellitus (T2DM) with normal cognitive function. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Aerobic training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 20 Mar 2020
- 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 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed of T2DM based on the 1999 diagnostic criteria of the WHO;
- Had normal muscle strength; 3.18.5≤BMI≤35kg/m2;
- 4.Had normal cognitive function ( MMSE ≥27 points, MoCA ≥26 points) ; 5.Primary school education or above ( Participants were able to fill in the scale) ; 6.Aged 60-75 years; 7.Had ≥5 years duration of T2DM; 8.Had no evidence of hearing or visual impairment and communication difficulties; 9.Were willing to participate in the study and signed informed consent voluntarily.
Who cannot join
- With severe acute complications of diabetes;
- Serious heart, liver and kidney dysfunction, and cardiovascular and cerebrovascular diseases, such as cerebral infarction, cerebral hemorrhage, etc.;
- Pregnant and lactating women;
- Sleep disorders (PSQI >7 points);
- Had a family history of dementia;
- Alcohol dependence and oral medications that affect cognitive function (such as antipsychotic drugs, sedative hypnotics, etc.);
- Contraindications for MRI, such as metal implant in the body.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine
Nanjing, Jiangsu, 210028
About this study
Official title: Effects of Aerobic Training on Pancreatic Fat and Cognitive Function in Patients With Type 2 Diabetes
The primary aim of this study was to evaluate the difference in cognitive function and brain functional structure between exercise group and control group by performing regular one-year moderate-intensity aerobic training in type 2 diabetes mellitus (T2DM) with normal cognitive function. The secondary aim of this study was to explore the effects of six-month regular moderate-intensity aerobic training on pancreatic fat content, metabolic index of glucose and lipid, as well as cardiovascular risks in patients type 2 diabetes mellitus.
Read the detailed description
In recent years, more attention has been paid to the role of aerobic exercise in improving cognitive ability, but there is still a lack of prospective studies on the T2DM population with normal cognitive function. Therefore, the purpose of this study is to compare the differences of cognitive function and hippocampal volume between exercise group and non-exercise group by regular moderate-intensity aerobic exercise intervention for one year in T2DM patients with normal cognitive function to evaluate the impact of aerobic exercise on cognitive function and hippocampal volume for these patients and provide scientific evidence for early prevention and delaying the occurrence of cognitive dysfunction in patients with T2DM. Pancreatic fat deposition in patients with type 2 diabetes is not only a simple fat accumulation but also an early marker of insulin resistance. In this study, The effectiveness of six months of an aerobic exercise intervention on pancreas fat reduction for type 2 diabetes patients was examed.
In this study, 106 T2DM patients who met the inclusion criteria were enrolled and randomized into two groups. All patients received diabetes education(once a month, the course will be focused on basic knowledge of diabetes, diet management, and blood glucose monitoring). The control group followed their regular lifestyle without exercise intervention and recorded 24-hour dietary intake. The aerobic training group was supervised by the trainers who had received professional training and given 60min moderate aerobic rhythmic exercise (including 5min warm-up, 50min aerobic exercise, and 5min stretching exercise).
Baseline assessment included demographic data, duration of diabetes, body mass index（BMI）, waist circumference（WC）, hip circumference（HC）, systolic blood press（SBP）, diastolic blood press（DBP）, smoking and drinking, drug use, acute and chronic complications of diabetes, other chronic complications, 24-hour diet review, international physical activity questionnaire (IPAQ).
Evaluation after 6 months of intervention included pancreatic fat content(PFC), liver fat content (LFC), visceral adipose tissue (VAT), subcutaneous adipose tissue(SAT), fasting plasma glucose (FPG), 2-hour postprandial blood glucose(2hPG), hemoglobin A1c(HbA1c), fasting insulin (FINS), homeostasis model assessment of insulin resistance(HOMA2-IR), homeostasis model assessment of Beta-cell function (HOMA2-β), early insulin secretion index(Δ I30 / Δ G30), total cholesterol(TC), triglycerides(TG),high-density-lipoprotein-cholesterol(HDL-C),low-density lipoprotein cholesterol(LDL-C). The Framingham cardiovascular risk scale (Framingham) and 10-year ischemic cardiovascular disease risk assessment (ICVD) scores were calculated.
Evaluation after 12 months of intervention included fasting plasma glucose(FPG),30 minutes postprandial glucose(30minPG), 2-hour postprandial glucose(2hPG)，hemoglobin A1c(HbA1c), fasting insulin(FINS),30 minutes Insulin(30minINS), homeostasis model assessment of insulin resistance(HOMA2-IR),homeostasis model assessment of Beta cell function(HOMA2-β),early insulin secretion index(Δ I30 / Δ G30),totalcholesterol(TC),triglycerides(TG),high-density-lipoprotein cholesterol( HDL-c），low-density-lipoprotein cholesterol(LDL-c),muscle mass, right, left hippocampal volume of hippocampal volume, the hippocampal volume, and total physical activity energy expenditure, total moderate physical activity energy expenditure. In addition to this, cognitive function (MMSE, MoCA) were also evaluated.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Aerobic training
- Keywords
- aerobic training, type 2 diabetes mellitus, pancreatic fat content, cognitive function, hippocampal volume
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic trainingBehavioural
The intervention was aerobic rhythmic training under the guidance and supervision of a professional. The aerobic training program required participants to exercise 3 days/week for 60 minutes/session (including 5-10 minutes of warm-up and 50 minutes aerobic training and 5-10 minutes to relax). All patients received an open class, relate to diabetes health education．
| Study group | Role | What they receive |
|---|---|---|
| Aerobic training group | Experimental | The aerobic training group was performed 3 times/week for 60 minutes/session(including 5 minutes of warm-up, 50 minutes aerobic rhythmic exercise and 5 minutes to relax) for moderate(60 to 70% of participants' HRmax) aerobic rhythmic exercise. All patients received an open class, relate to diabetes health education. The intervention lasted for 6 months. Receives: Behavioral: Aerobic training |
| Control group | No intervention | Patients in control group remained the original lifestyle unchanged. All patients received an open class, relate to diabetes health education. |
| Intervention group | Experimental | The intervention was aerobic rhythmic exercise, with intensive training under the guidance and supervision of a professional.The aerobic training program required participants to exercise 3 days/week for 60 minutes/session (including 5-10 minutes of warm-up and 5-10 minutes flexibility exercises). Participants were educated on aerobic exercises (aerobic dancing) with music.The intervention lasted for one year. Receives: Behavioral: Aerobic training |
| Compared group | No intervention | The control group was instructed to maintain their usual habits and received no structured exercise intervention. But the form, frequency and time of movement of each participant must be recorded.Participants receive an open diabetes health education class once a month, which is taught by a specially trained diabetes nurse. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function scale(1)
Mini-mental State Examination(MMSE) includes five aspects: orientation, memory, attention and calculation, recall and language ability, with a total score of 30.The scoring standard is: 27-30 is normal;< 27 was divided into cognitive impairment;Mild cognitive impairment ≥21 and < 27 points;Moderate cognitive impairment 10-20;Severe cognitive impairment ≤9, the higher the score, the better the cognitive function.
Measured: 12 months
Cognitive function scale(2)
The Montreal Cognitive Assessment Scale (MoCA) includes eight aspects: visuospatial and executive function, nomenclature, memory, attention, language, abstraction, delayed recall, and orientation for a total of 30 points.The score criteria are as follows: ≥26 is considered as normal cognitive function; < 26 is considered as cognitive dysfunction. If the number of years of education ≤12 years, the score is added 1 point to correct cultural influence. The lower the score, the worse the cognitive function.
Measured: 12 months
Brain functional structure---Hippocampal volume
Hippocampal volume measurement by the same operation, all patients using 3D brain volume sequence (3D - BRAVO) image data acquisition of high resolution T1W1 brain structure, specific scanning parameters is as follows: repetition time (TR) = 9.5 ms, Time of Echo(TE) = 3.9 ms, Flip angle (FA) = 12 °, matrix=320 x 320, scanned area (FOV) = 22 x 22 cm, depth of stratum=1.5mm, interlamellar spacing =1.5mm.
Measured: 12 months
Abdominal fat Abdominal fat
Pancreatic fat content（PFC,%）
Measured: 6 months
Secondary outcomes (11)
Glycemic control(1)
Fasting Plasma Glucose(FPG, mmol/L)
Measured: 12 months
Glycemic control(2)
2-hour postprandial blood glucose (2hPG, mmol/L)
Measured: Time Frame: 12 months
Hemoglobin A1c
Hemoglobin A1c(HbA1c,mml/ml)
Measured: 12 months
HOMA2-IR and HOMA2-β
Homa-IR is an indicator used to assess an individual's level of insulin resistance, HOMA-β is used to evaluate the function of individual islet cells, ΔI30/ΔG30（The ratio of net insulin to glucose increment 30 min after glucose load）
Measured: 12 months
Blood lipids
Total Cholesterol(TC,mmol/L),Triglycerides(TG,mmol/L), High-density-lipoprotein Cholesterol(HDL-c,mmol/L), Low-density-lipoprotein Cholesterol(LDL-c,mmol/L)
Measured: 12 months
Other abdominal fat(1)
Liver fat content(LFC,%)
Measured: 6 months
Other abdominal fat(2)
Visceral adipose tissue(VAT,cm²)
Measured: 6 months
Other abdominal fat(3)
Subcutaneous adipose tissue(SAT,cm²)
Measured: 6 months
The international physical activity questionnaire
The international physical activity questionnaire (IPAQ) content mainly includes five aspects: physical activity of the relevant related work (including high levels of physical activity, moderate physical activity, walking), traffic-related physical activity (including bus, ride a bike, on foot), housework on physical activity (courtyard in heavy physical activity, physical activity among the courtyard, indoor physical activity), entertainment and leisure-time physical activity (walking, heavy physical activity, moderate physical activity) and meditation time. Participants were asked to recall the amount of time spent in each type of activity during the past week, including the number of days during the week and the number of hours spent each day, and to assign MET values to each type of physical activity using the MTE table. Energy consumption (MEt-min /week) for each type of physical activity = metabolic value of the activity (MET) × activity time per day (min) × activity days /week
Measured: 6 months
The Framingham Cardiovascular Risk Scale
The Framingham Cardiovascular Risk Scale is used to predict 10-year cardiovascular disease severity, cardiovascular event risk, and risk stratification. The scale includes 6 risk factors, including gender, age, TC, HDL-C, SBP, and smoking status. The total score was determined according to gender, then the corresponding scores were determined according to age, TC, HDL-C, SBP, and smoking status. The total score was calculated by adding up, and then the 10-year incidence risk of CHD corresponding to the total score was looked up. 10-year cardiovascular risk of < 10% is a low risk, 10-20% is a moderate risk, and > 20% is a high risk.
Measured: 6 months
The 10-year risk assessment table for Ischemic cardiovascular disease
The 10-year risk assessment table for Ischemic cardiovascular disease (ICVD) in Chinese people was used to calculate the 10-year risk of ICVD. The scores of men and women were selected based on their gender, and the corresponding scores of age, systolic blood pressure, BMI, TC, smoking, and diabetes were checked in the table. Then the total score was calculated and the absolute risk of ICVD was checked according to the total score (%). The 10-year risk of ICVD is very low, 5%-10% is low, 10%-20 is moderate, 20%-40% is high, and ≥40% is very high.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Dec 2018
- Primary completion1 Jan 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lou Qingqing, Nanjing University of Traditional Chinese Medicine
- Investigators
- Qingqing Lou, PhD, Principal investigator, Nanjing University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489966
- Sponsor's protocol ID
- 2019LWKY009
- Status last verified
- Jan 2021
- First submitted
- 17 Jul 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.
PubMed 9686693Wang Y, Wang L, Yan J, Yuan X, Lou QQ. Aerobic Training Increases Hippocampal Volume and Protects Cognitive Function for Type 2 Diabetes Patients with Normal Cognition. Exp Clin Endocrinol Diabetes. 2023 Nov;131(11):605-614. doi: 10.1055/a-2105-0799. Epub 2023 Jun 2.
PubMed 37268011
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Training on Pancreatic Fat and Cognitive Function in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04489966
- Acronym / sponsor ID
- 2019LWKY009
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- aerobic training, type 2 diabetes mellitus, pancreatic fat content, cognitive function, hippocampal volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Nanjing University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 28 Jul 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.
The primary aim of this study was to evaluate the difference in cognitive function and brain functional structure between exercise group and control group by performing regular one-year moderate-intensity aerobic training in type 2 diabetes mellitus (T2DM) with normal cognitive function. The secondary aim of this study was to explore the effects of six-month regular moderate-intensity aerobic training on pancreatic fat content, metabolic index of glucose and lipid, as well as cardiovascular risks in patients type 2 diabetes mellitus.
Detailed description
In recent years, more attention has been paid to the role of aerobic exercise in improving cognitive ability, but there is still a lack of prospective studies on the T2DM population with normal cognitive function. Therefore, the purpose of this study is to compare the differences of cognitive function and hippocampal volume between exercise group and non-exercise group by regular moderate-intensity aerobic exercise intervention for one year in T2DM patients with normal cognitive function to evaluate the impact of aerobic exercise on cognitive function and hippocampal volume for these patients and provide scientific evidence for early prevention and delaying the occurrence of cognitive dysfunction in patients with T2DM. Pancreatic fat deposition in patients with type 2 diabetes is not only a simple fat accumulation but also an early marker of insulin resistance. In this study, The effectiveness of six months of an aerobic exercise intervention on pancreas fat reduction for type 2 diabetes patients was examed.
In this study, 106 T2DM patients who met the inclusion criteria were enrolled and randomized into two groups. All patients received diabetes education(once a month, the course will be focused on basic knowledge of diabetes, diet management, and blood glucose monitoring). The control group followed their regular lifestyle without exercise intervention and recorded 24-hour dietary intake. The aerobic training group was supervised by the trainers who had received professional training and given 60min moderate aerobic rhythmic exercise (including 5min warm-up, 50min aerobic exercise, and 5min stretching exercise).
Baseline assessment included demographic data, duration of diabetes, body mass index（BMI）, waist circumference（WC）, hip circumference（HC）, systolic blood press（SBP）, diastolic blood press（DBP）, smoking and drinking, drug use, acute and chronic complications of diabetes, other chronic complications, 24-hour diet review, international physical activity questionnaire (IPAQ).
Evaluation after 6 months of intervention included pancreatic fat content(PFC), liver fat content (LFC), visceral adipose tissue (VAT), subcutaneous adipose tissue(SAT), fasting plasma glucose (FPG), 2-hour postprandial blood glucose(2hPG), hemoglobin A1c(HbA1c), fasting insulin (FINS), homeostasis model assessment of insulin resistance(HOMA2-IR), homeostasis model assessment of Beta-cell function (HOMA2-β), early insulin secretion index(Δ I30 / Δ G30), total cholesterol(TC), triglycerides(TG),high-density-lipoprotein-cholesterol(HDL-C),low-density lipoprotein cholesterol(LDL-C). The Framingham cardiovascular risk scale (Framingham) and 10-year ischemic cardiovascular disease risk assessment (ICVD) scores were calculated.
Evaluation after 12 months of intervention included fasting plasma glucose(FPG),30 minutes postprandial glucose(30minPG), 2-hour postprandial glucose(2hPG)，hemoglobin A1c(HbA1c), fasting insulin(FINS),30 minutes Insulin(30minINS), homeostasis model assessment of insulin resistance(HOMA2-IR),homeostasis model assessment of Beta cell function(HOMA2-β),early insulin secretion index(Δ I30 / Δ G30),totalcholesterol(TC),triglycerides(TG),high-density-lipoprotein cholesterol( HDL-c），low-density-lipoprotein cholesterol(LDL-c),muscle mass, right, left hippocampal volume of hippocampal volume, the hippocampal volume, and total physical activity energy expenditure, total moderate physical activity energy expenditure. In addition to this, cognitive function (MMSE, MoCA) were also evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aerobic training group | Experimental | Behavioral: Aerobic trainingThe aerobic training group was performed 3 times/week for 60 minutes/session(including 5 minutes of warm-up, 50 minutes aerobic rhythmic exercise and 5 minutes to relax) for moderate(60 to 70% of participants' HRmax) aerobic rhythmic exercise. All patients received an open class, relate to diabetes health education. The intervention lasted for 6 months. |
| Control group | No intervention | –Patients in control group remained the original lifestyle unchanged. All patients received an open class, relate to diabetes health education. |
| Intervention group | Experimental | Behavioral: Aerobic trainingThe intervention was aerobic rhythmic exercise, with intensive training under the guidance and supervision of a professional.The aerobic training program required participants to exercise 3 days/week for 60 minutes/session (including 5-10 minutes of warm-up and 5-10 minutes flexibility exercises). Participants were educated on aerobic exercises (aerobic dancing) with music.The intervention lasted for one year. |
| Compared group | No intervention | –The control group was instructed to maintain their usual habits and received no structured exercise intervention. But the form, frequency and time of movement of each participant must be recorded.Participants receive an open diabetes health education class once a month, which is taught by a specially trained diabetes nurse. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed of T2DM based on the 1999 diagnostic criteria of the WHO;
- Had normal muscle strength; 3.18.5≤BMI≤35kg/m2;
- 4.Had normal cognitive function ( MMSE ≥27 points, MoCA ≥26 points) ; 5.Primary school education or above ( Participants were able to fill in the scale) ; 6.Aged 60-75 years; 7.Had ≥5 years duration of T2DM; 8.Had no evidence of hearing or visual impairment and communication difficulties; 9.Were willing to participate in the study and signed informed consent voluntarily.
Key exclusion criteria (7 listed)
- With severe acute complications of diabetes;
- Serious heart, liver and kidney dysfunction, and cardiovascular and cerebrovascular diseases, such as cerebral infarction, cerebral hemorrhage, etc.;
- Pregnant and lactating women;
- Sleep disorders (PSQI >7 points);
- Had a family history of dementia;
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 |
|---|---|---|
| Aerobic trainingThe intervention was aerobic rhythmic training under the guidance and supervision of a professional. The aerobic training program required participants to exercise 3 days/week for 60 minutes/session (including 5-10 minutes of warm-up and 50 minutes aerobic training and 5-10 minutes to relax). All patients received an open class, relate to diabetes health education． | Behavioural | Aerobic training group, Intervention group |
Primary outcome
Cognitive function scale(1)
Time frame: 12 months
Mini-mental State Examination(MMSE) includes five aspects: orientation, memory, attention and calculation, recall and language ability, with a total score of 30.The scoring standard is: 27-30 is normal;< 27 was divided into cognitive impairment;Mild cognitive impairment ≥21 and < 27 points;Moderate cognitive impairment 10-20;Severe cognitive impairment ≤9, the higher the score, the better the cognitive function.
Cognitive function scale(2)
Time frame: 12 months
The Montreal Cognitive Assessment Scale (MoCA) includes eight aspects: visuospatial and executive function, nomenclature, memory, attention, language, abstraction, delayed recall, and orientation for a total of 30 points.The score criteria are as follows: ≥26 is considered as normal cognitive function; < 26 is considered as cognitive dysfunction. If the number of years of education ≤12 years, the score is added 1 point to correct cultural influence. The lower the score, the worse the cognitive function.
Brain functional structure---Hippocampal volume
Time frame: 12 months
Hippocampal volume measurement by the same operation, all patients using 3D brain volume sequence (3D - BRAVO) image data acquisition of high resolution T1W1 brain structure, specific scanning parameters is as follows: repetition time (TR) = 9.5 ms, Time of Echo(TE) = 3.9 ms, Flip angle (FA) = 12 °, matrix=320 x 320, scanned area (FOV) = 22 x 22 cm, depth of stratum=1.5mm, interlamellar spacing =1.5mm.
Abdominal fat Abdominal fat
Time frame: 6 months
Pancreatic fat content（PFC,%）
11 secondary outcomes
Glycemic control(1)
Time frame: 12 months
Glycemic control(2)
Time frame: Time Frame: 12 months
Hemoglobin A1c
Time frame: 12 months
HOMA2-IR and HOMA2-β
Time frame: 12 months
Blood lipids
Time frame: 12 months
Other abdominal fat(1)
Time frame: 6 months
Other abdominal fat(2)
Time frame: 6 months
Other abdominal fat(3)
Time frame: 6 months
The international physical activity questionnaire
Time frame: 6 months
The Framingham Cardiovascular Risk Scale
Time frame: 6 months
The 10-year risk assessment table for Ischemic cardiovascular disease
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Results publication: PubMed 9686693Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.
- Derived from this study: PubMed 37268011Wang Y, Wang L, Yan J, Yuan X, Lou QQ. Aerobic Training Increases Hippocampal Volume and Protects Cognitive Function for Type 2 Diabetes Patients with Normal Cognition. Exp Clin Endocrinol Diabetes. 2023 Nov;131(11):605-614. doi: 10.1055/a-2105-0799. Epub 2023 Jun 2.
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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.
Qingqing Lou, PhD principal investigator
Nanjing University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training in people with Type 2 Diabetes Mellitus, run by Nanjing University of Traditional Chinese Medicine at 1 site in China.
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 7 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: finished, as of the sponsor's last update on 5 Jan 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cognitive function scale(1) (time frame: 12 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?
On the ClinicalTrials.gov record for NCT04489966, which also lists 2 linked publications.
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 5 Jan 2021; AzTrials last refreshed its copy on 6 Nov 2026.