Type 2 Diabetes Mellitus (T2DM)Association BeNCT07711834
Exercise and PPARGC1A rs8192678 in Older Adults With Type 2 Diabetes and Cognitive Impairment
A study testing Combined aerobic and resistance exercise in people with Type 2 Diabetes Mellitus (T2DM) and Cognitive Impairment, run by Harbin Sport University at 1 site in China.
Trial summary
This completed single-arm interventional study evaluated changes in metabolic control, cognitive function, and health-related physical fitness following a 12-week combined aerobic and resistance exercise program in older adults with type 2 diabetes mellitus and cognitive impairment. Read more about this study
- Who is it for?
- Ages 65 to 79 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Cognitive Impairment
- What is being tested?
- Combined aerobic and resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 1 Jun 2025
- 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 to 79 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosed with type 2 diabetes mellitus.
- No regular exercise training during the previous six months.
- Aged 65 to 79 years.
- Self-reported memory decline and Montreal Cognitive Assessment score <26.
- Stable antidiabetic medication use and stable dietary control.
- Participant or family member provided informed consent.
Who cannot join
- Diabetic ketoacidosis within the previous three months.
- Visual or hearing impairment or other conditions affecting cognitive assessment.
- Fracture, limb disability, or other motor disorders affecting exercise participation.
- History of psychiatric disorders.
- History of stroke, brain tumor, hypothyroidism, or other diseases that may affect cognitive function.
- Poor compliance or failure to follow the prescribed diet or exercise requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between PPARGC1A rs8192678 Polymorphism and the Effects of a 12-Week Combined Aerobic and Resistance Exercise Intervention in Older Adults With Type 2 Diabetes Mellitus and Cognitive Impairment
This completed single-arm interventional study evaluated changes in metabolic control, cognitive function, and health-related physical fitness following a 12-week combined aerobic and resistance exercise program in older adults with type 2 diabetes mellitus and cognitive impairment. The study also explored whether the magnitude of response to exercise differed according to PPARGC1A rs8192678 genotype.
A total of 75 participants were genotyped, and 45 participants were included in a balanced genotype-stratified cohort, consisting of 15 participants with the CC genotype, 15 with the CT genotype, and 15 with the TT genotype. All participants received the same exercise intervention and were assessed at baseline and at Week 12.
Read the detailed description
This was a completed, retrospectively registered, single-arm exercise intervention study with prespecified genotype-stratified analyses. The study examined whether PPARGC1A rs8192678 genotype was associated with interindividual variation in response to a standardized combined aerobic and resistance exercise program in older adults with type 2 diabetes mellitus and cognitive impairment.
PPARGC1A rs8192678 genotyping was performed on peripheral blood DNA using Kompetitive Allele-Specific Polymerase Chain Reaction (KASP). Genotype was used as an analytical stratification factor and did not determine intervention assignment. From 75 genotyped participants, a balanced cohort of 45 participants was included, comprising 15 participants with each of the CC, CT, and TT genotypes.
All participants received the same 12-week exercise intervention. Aerobic exercise consisted of group-based aerobics performed four times per week. Aerobic exercise duration progressed from 20 minutes per session during Weeks 1-4 to 30 minutes during Weeks 5-8 and 40 minutes during Weeks 9-12. Exercise intensity progressed from 50%-60% of age-predicted maximum heart rate during Weeks 1-6 to 60%-70% during Weeks 7-12. Maximum heart rate was estimated using the equation: 207 - 0.7 × age.
Resistance exercise using elastic bands was performed twice per week. Resistance exercise duration progressed from 20 minutes during Weeks 1-4 to 30 minutes during Weeks 5-8 and 40 minutes during Weeks 9-12. Intensity progressed from 40%-50% of estimated one-repetition maximum during Weeks 1-6 to 50%-60% during Weeks 7-12. One-repetition maximum was estimated from a 10-15 repetition-maximum test using the Brzycki equation: estimated 1RM = load/[1.0278 - (0.0278 × number of repetitions)].
Exercise sessions included a 5-10-minute warm-up and cool-down period. Heart-rate monitors, supervised instruction, standardized exercise demonstrations, and safety monitoring were used to maintain the prescribed intensity and intervention quality. Measurements were obtained before the intervention and after 12 weeks. The main analysis assessed within-participant change from baseline, and exploratory analyses compared changes among genotype groups. For variables with significant baseline differences, analysis of covariance was performed using the baseline value as a covariate.
- Being tested
- Combined aerobic and resistance exercise
- Keywords
- Older, adults, Type 2 diabetes mellitus, Cognitive impairment, Exercise intervention, Aerobic exercise, Resistance exercise, PPARGC1A, rs8192678, Genetic polymorphism, Glycolipid metabolism, Montreal Cognitive Assessment, Health-related 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.
Combined aerobic and resistance exerciseBehavioural
A 12-week combined exercise program including aerobics and elastic-band resistance training. Aerobic exercise was performed four times per week, with intensity progressing from 50%-60% HRmax during weeks 1-6 to 60%-70% HRmax during weeks 7-12. Resistance exercise was performed twice per week using elastic bands, with intensity progressing from 40%-50% 1RM during weeks 1-6 to 50%-60% 1RM during weeks 7-12. Exercise duration gradually increased from 20 minutes to 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Combined Aerobic and Resistance Exercise | Experimental | Participants received a 12-week combined aerobic and resistance exercise program, including aerobic exercise four times per week and elastic-band resistance exercise twice per week. Exercise intensity and duration were progressively increased during the intervention. Receives: Behavioral: Combined aerobic and resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glycated Hemoglobin at 12 Weeks
Change in glycated hemoglobin percentage from baseline to the end of the 12-week exercise intervention.
Measured: Baseline and 12 weeks
Change From Baseline in Fasting Plasma Glucose at 12 Weeks
Change in fasting plasma glucose concentration from baseline to the end of the 12-week exercise intervention.
Measured: Baseline and 12 weeks
Change From Baseline in Montreal Cognitive Assessment Total Score at 12 Weeks
Global cognitive function was assessed using the Montreal Cognitive Assessment (MoCA). The instrument contains 12 tasks covering eight cognitive domains. The total score is reported on a scale ranging from 0 to 30 points. In accordance with the study protocol, 1 point was added for participants with 12 or fewer years of education. Higher scores indicate better cognitive function. Change from baseline was calculated as the Week 12 score minus the baseline score; a positive change indicates improvement in cognitive function.
Measured: Baseline and 12 weeks
Secondary outcomes (15)
Change From Baseline in Fasting Insulin at 12 Weeks
Measured: Baseline and 12 weeks
Change From Baseline in Total Cholesterol at 12 Weeks
Measured: Baseline and 12 weeks
Change From Baseline in Triglycerides at 12 Weeks
Measured: Baseline and 12 weeks
Change From Baseline in High-Density Lipoprotein Cholesterol at 12 Weeks
Measured: Baseline and 12 weeks
Change From Baseline in Low-Density Lipoprotein Cholesterol at 12 Weeks
Measured: Baseline and 12 weeks
Change From Baseline in Body Weight at 12 Weeks
Measured: Baseline and 12 weeks
Change From Baseline in Muscle Mass at 12 Weeks
Measured: Baseline and 12 weeks
Change From Baseline in Body Mass Index at 12 Weeks
Measured: Baseline and 12 weeks
Change From Baseline in Body Fat Percentage at 12 Weeks
Measured: Baseline and 12 weeks
Change From Baseline in Vital Capacity Measured Using a GMCS-FHL3 Vital Capacity Tester at 12 Weeks
Vital capacity was measured in milliliters using a GMCS-FHL3 vital capacity tester manufactured by Beijing Xindong Huateng Sports Equipment Co., Ltd. Participants were tested in a standing position. After taking several deep breaths, each participant inhaled maximally and then exhaled continuously and completely through the mouthpiece without taking an additional breath. Two trials were performed, and the highest recorded value was used for analysis. Higher values indicate better respiratory function. Change from baseline was calculated as the Week 12 value minus the baseline value; a positive change indicates improvement.
Measured: Baseline and 12 weeks
Change From Baseline in Relative Handgrip Strength, Calculated as Maximum Handgrip Strength Divided by Body Weight, at 12 Weeks
Maximum handgrip strength was measured in kilograms using a GMCS-WCS3 digital handgrip dynamometer manufactured by Beijing Xindong Huateng Sports Equipment Co., Ltd. Participants were assessed while standing upright with the tested arm naturally extended beside the body without touching the trunk. Each hand was tested twice, and the highest value obtained across the four trials was used.
Relative handgrip strength was calculated as maximum handgrip strength in kilograms divided by body weight in kilograms and was reported as a dimensionless kg/kg ratio. This is a continuous physiological ratio rather than a bounded questionnaire scale. Its theoretical minimum is 0, and it has no fixed maximum. Higher values indicate greater handgrip strength relative to body weight. Change from baseline was calculated as the Week 12 ratio minus the baseline ratio; a positive change indicates improvement.
Measured: Baseline and 12 weeks
Change From Baseline in Sit-and-Reach Performance at 12 Weeks
Measured: Baseline and 12 weeks
Change From Baseline in 30-Second Sit-to-Stand Performance at 12 Weeks
Measured: Baseline and 12 weeks
Change From Baseline in One-Legged Standing With Eyes Closed at 12 Weeks
Measured: Baseline and 12 weeks
Change From Baseline in Choice Reaction Time at 12 Weeks
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Mar 2025
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants received the same 12-week combined aerobic and resistance exercise intervention. Participants were stratified by PPARGC1A rs8192678 genotype for subgroup analysis, but genotype subgroups were not separate intervention arms.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbin Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nijia Meng, Harbin Sport University
- Investigators
- Nijia Meng, Associate Professor, Principal investigator, Harbin Sport UniversityXichao Zhang, Study director, Harbin Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711834
- Sponsor's protocol ID
- HSU-2025115-PPARGC1A-T2DMCI
- Acronym
- Association Be
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between PPARGC1A rs8192678 Polymorphism and the Effects of a 12-Week Combined Aerobic and Resistance Exercise Intervention in Older Adults With Type 2 Diabetes Mellitus and Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07711834
- Acronym / sponsor ID
- Association Be / HSU-2025115-PPARGC1A-T2DMCI
- Keywords
- Older, adults, Type 2 diabetes mellitus, Cognitive impairment, Exercise intervention, Aerobic exercise, Resistance exercise, PPARGC1A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Harbin Sport UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 17 Jul 2026 (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 completed single-arm interventional study evaluated changes in metabolic control, cognitive function, and health-related physical fitness following a 12-week combined aerobic and resistance exercise program in older adults with type 2 diabetes mellitus and cognitive impairment. The study also explored whether the magnitude of response to exercise differed according to PPARGC1A rs8192678 genotype.
A total of 75 participants were genotyped, and 45 participants were included in a balanced genotype-stratified cohort, consisting of 15 participants with the CC genotype, 15 with the CT genotype, and 15 with the TT genotype. All participants received the same exercise intervention and were assessed at baseline and at Week 12.
Detailed description
This was a completed, retrospectively registered, single-arm exercise intervention study with prespecified genotype-stratified analyses. The study examined whether PPARGC1A rs8192678 genotype was associated with interindividual variation in response to a standardized combined aerobic and resistance exercise program in older adults with type 2 diabetes mellitus and cognitive impairment.
PPARGC1A rs8192678 genotyping was performed on peripheral blood DNA using Kompetitive Allele-Specific Polymerase Chain Reaction (KASP). Genotype was used as an analytical stratification factor and did not determine intervention assignment. From 75 genotyped participants, a balanced cohort of 45 participants was included, comprising 15 participants with each of the CC, CT, and TT genotypes.
All participants received the same 12-week exercise intervention. Aerobic exercise consisted of group-based aerobics performed four times per week. Aerobic exercise duration progressed from 20 minutes per session during Weeks 1-4 to 30 minutes during Weeks 5-8 and 40 minutes during Weeks 9-12. Exercise intensity progressed from 50%-60% of age-predicted maximum heart rate during Weeks 1-6 to 60%-70% during Weeks 7-12. Maximum heart rate was estimated using the equation: 207 - 0.7 × age.
Resistance exercise using elastic bands was performed twice per week. Resistance exercise duration progressed from 20 minutes during Weeks 1-4 to 30 minutes during Weeks 5-8 and 40 minutes during Weeks 9-12. Intensity progressed from 40%-50% of estimated one-repetition maximum during Weeks 1-6 to 50%-60% during Weeks 7-12. One-repetition maximum was estimated from a 10-15 repetition-maximum test using the Brzycki equation: estimated 1RM = load/[1.0278 - (0.0278 × number of repetitions)].
Exercise sessions included a 5-10-minute warm-up and cool-down period. Heart-rate monitors, supervised instruction, standardized exercise demonstrations, and safety monitoring were used to maintain the prescribed intensity and intervention quality. Measurements were obtained before the intervention and after 12 weeks. The main analysis assessed within-participant change from baseline, and exploratory analyses compared changes among genotype groups. For variables with significant baseline differences, analysis of covariance was performed using the baseline value as a covariate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants received the same 12-week combined aerobic and resistance exercise intervention. Participants were stratified by PPARGC1A rs8192678 genotype for subgroup analysis, but genotype subgroups were not separate intervention arms.
| Arm | Type | Receives |
|---|---|---|
| Combined Aerobic and Resistance Exercise | Experimental | Behavioral: Combined aerobic and resistance exerciseParticipants received a 12-week combined aerobic and resistance exercise program, including aerobic exercise four times per week and elastic-band resistance exercise twice per week. Exercise intensity and duration were progressively increased during the intervention. |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Diagnosed with type 2 diabetes mellitus.
- No regular exercise training during the previous six months.
- Aged 65 to 79 years.
- Self-reported memory decline and Montreal Cognitive Assessment score <26.
- Stable antidiabetic medication use and stable dietary control.
Key exclusion criteria (6 listed)
- Diabetic ketoacidosis within the previous three months.
- Visual or hearing impairment or other conditions affecting cognitive assessment.
- Fracture, limb disability, or other motor disorders affecting exercise participation.
- History of psychiatric disorders.
- History of stroke, brain tumor, hypothyroidism, or other diseases that may affect cognitive function.
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 |
|---|---|---|
| Combined aerobic and resistance exerciseA 12-week combined exercise program including aerobics and elastic-band resistance training. Aerobic exercise was performed four times per week, with intensity progressing from 50%-60% HRmax during weeks 1-6 to 60%-70% HRmax during weeks 7-12. Resistance exercise was performed twice per week using elastic bands, with intensity progressing from 40%-50% 1RM during weeks 1-6 to 50%-60% 1RM during weeks 7-12. Exercise duration gradually increased from 20 minutes to 40 minutes. | Behavioural | Combined Aerobic and Resistance Exercise |
Primary outcome
Change From Baseline in Glycated Hemoglobin at 12 Weeks
Time frame: Baseline and 12 weeks
Change in glycated hemoglobin percentage from baseline to the end of the 12-week exercise intervention.
Change From Baseline in Fasting Plasma Glucose at 12 Weeks
Time frame: Baseline and 12 weeks
Change in fasting plasma glucose concentration from baseline to the end of the 12-week exercise intervention.
Change From Baseline in Montreal Cognitive Assessment Total Score at 12 Weeks
Time frame: Baseline and 12 weeks
Global cognitive function was assessed using the Montreal Cognitive Assessment (MoCA). The instrument contains 12 tasks covering eight cognitive domains. The total score is reported on a scale ranging from 0 to 30 points. In accordance with the study protocol, 1 point was added for participants with 12 or fewer years of education. Higher scores indicate better cognitive function. Change from baseline was calculated as the Week 12 score minus the baseline score; a positive change indicates improvement in cognitive function.
15 secondary outcomes
Change From Baseline in Fasting Insulin at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Total Cholesterol at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Triglycerides at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in High-Density Lipoprotein Cholesterol at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Low-Density Lipoprotein Cholesterol at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Body Weight at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Muscle Mass at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Body Mass Index at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Body Fat Percentage at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Vital Capacity Measured Using a GMCS-FHL3 Vital Capacity Tester at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Relative Handgrip Strength, Calculated as Maximum Handgrip Strength Divided by Body Weight, at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Sit-and-Reach Performance at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in 30-Second Sit-to-Stand Performance at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in One-Legged Standing With Eyes Closed at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Choice Reaction Time at 12 Weeks
Time frame: Baseline and 12 weeks
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 17 Jul 2026.
Related trials for Type 2 Diabetes Mellitus (T2DM)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes
RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Obesity, Overweight
RecruitingObservational study
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
T2DM (Type 2 Diabetes Mellitus)
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
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.
Nijia Meng, Associate Professor principal investigator
Harbin Sport University
Xichao Zhang study director
Harbin Sport 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 Combined aerobic and resistance exercise in people with Type 2 Diabetes Mellitus (T2DM) and Cognitive Impairment, run by Harbin Sport University 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 6 inclusion and 6 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 17 Jul 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 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?
Change From Baseline in Glycated Hemoglobin at 12 Weeks (time frame: Baseline and 12 weeks). 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 17 Jul 2026.