Type 2 Diabetes Mellitus (T2DM)NCT07398495
Multimodal Training Effects in Middle-Aged and Older Adults With Diabetic Sarcopenia
A study testing Multimodal Exercise Program in people with Type 2 Diabetes Mellitus (T2DM) and Sarcopenia, run by yueh chu wu at 1 site in Taiwan.
Trial summary
This study aims to investigate the effects of a 12-week multimodal exercise intervention on middle-aged and older adults (aged 45~85 years) with Type 2 Diabetes Mellitus (T2DM). The program combines supervised training, home-based sessions, and digital support to improve muscle function, physical performance… Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Sarcopenia
- What is being tested?
- Multimodal Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Feb 2026to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with both Type 2 Diabetes Mellitus (T2DM) and sarcopenia.
- Maintained on a stable regimen of oral hypoglycemic agents.
- Aged 45 years or older.
- Capable of communicating effectively in Mandarin or Taiwanese.
- Willing to provide informed consent or have it obtained from a legally authorized representative.
Who cannot join
- • Limited limb or joint function that prevents exercise (e.g., recent fractures or dislocations).
- Communication barriers or severe emotional/psychological issues (e.g., uncontrolled depression or severe mental illness).
- Severe cognitive impairment (e.g., dementia).
- End-stage renal disease (ESRD).
- Major comorbidities or complications, including active diabetic foot ulcers, amputation, recent myocardial infarction, severe autonomic neuropathy, or a history of stroke within the last 3 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chung Shan Medical University Hospital
Taichung, Taiwan, 402306
WU YUEH CHU, 886-4-24739595 ext. 20340, yueh.chu46240@gmail.com
About this study
Official title: Effects of Multimodal Training on Muscle Function and Glucose Metabolism in Middle-Aged and Older Adults With Type 2 Diabetes Mellitus and Sarcopenia
This study aims to investigate the effects of a 12-week multimodal exercise intervention on middle-aged and older adults (aged 45~85 years) with Type 2 Diabetes Mellitus (T2DM). The program combines supervised training, home-based sessions, and digital support to improve muscle function, physical performance, metabolic control, and quality of life.
Read the detailed description
Middle-aged and older adults with T2DM, particularly in Asian populations, face a heightened risk of sarcopenia. This condition leads to a decline in muscle mass and function, negatively impacting quality of life. Effective interventions are urgently needed to slow disease progression. This randomized controlled trial will recruit 128 adults. Participants will be randomly assigned to either a control group or an intervention group. The intervention involves a multimodal exercise program and educational materials, while the control group receives standard health education. Assessments will be conducted at baseline, week 12, and week 24 to evaluate physical function, sarcopenia risk, metabolic control, and quality of life.
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Sarcopenia
- Being tested
- Multimodal Exercise Program
- Medical subject headings
- Diabetes Mellitus, Type 2, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Exercise ProgramBehavioural
Also called Control Group
Participants will engage in a 12-week multimodal exercise program comprising supervised training sessions, home-based exercises, and digital support. To facilitate adherence and proper technique, participants will also receive a "Diabetes and Muscle Health Handbook" as a training guide.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Multimodal Exercise) | Experimental | • Arm Description: Participants in this group will engage in a 12-week multimodal exercise program. The program includes supervised training sessions, home-based exercises, and digital support. They will also receive a "Diabetes and Muscle Health Handbook" to guide their training. Receives: Behavioral: Multimodal Exercise Program |
| Control Group (Standard Care) | No intervention | Participants in this group will serve as the control. They will receive a "Nutrition and Muscle Health Education Sheet" at the beginning of the study. They will not participate in the multimodal exercise program and will continue with their routine health management based on existing medical advice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Function (5TSTS)
The Five-Times Sit-to-Stand Test (5TSTS) assesses lower limb muscle power. Participants are asked to stand up and sit down five times as quickly as possible with arms folded. The time to completion is recorded in seconds and analyzed as a continuous variable. According to the 2019 Asian Working Group for Sarcopenia (AWGS) consensus, a completion time of ≥ 12 seconds is considered abnormal and indicates low physical performance.
Measured: Change from Baseline at Week 12 and Week 24
Handgrip Strength (HGS)
Handgrip strength (HGS) is assessed using a digital dynamometer (e.g., Jamar or an equivalent device). During the assessment, participants stand with their testing arm fully extended. Two consecutive trials are performed for each hand, and the maximum grip strength value (in kilograms) is selected for data analysis. Based on the 2019 Asian Working Group for Sarcopenia (AWGS) consensus, low muscle strength is defined as < 28 kg for men and < 18 kg for women
Measured: Change from Baseline at Week 12 and Week 24
Skeletal Muscle Mass Index (SMI)
Determined by bioelectrical impedance analysis (BIA). Appendicular skeletal muscle mass (ASM, kg) is calculated as the sum of lean mass from both arms and legs. SMI is expressed as ASM divided by height squared (kg/m²). Low muscle mass is defined according to AWGS 2019 cut-off values (<7.0 kg/m² for men and <5.7 kg/m² for women).
Measured: Change from Baseline at Week 12 and Week 24
Sarcopenia Risk: Assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire combined with calf circumference measurement (SARC-CalF).
Assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire combined with calf circumference measurement (SARC-CalF). The SARC-F assesses 5 items scored 0-10. A calf circumference ≤34 cm (men) or ≤33 cm (women) adds 10 points. Total SARC-CalF scores range from 0 to 20. Higher scores indicate a higher risk of sarcopenia (a worse outcome). A total SARC-CalF score ≥11 indicates a high risk.
Measured: Change from Baseline at Week 12 and Week 24
Secondary outcomes (2)
Glycated Hemoglobin (HbA1c)
Metabolic control is evaluated by HbA1c levels. Venous blood samples are collected after an overnight fast and analyzed using standardized high-performance liquid chromatography (HPLC). Values are reported as percentages. According to the American Diabetes Association (ADA) guidelines, the target HbA1c level for patients with type 2 diabetes mellitus (T2DM) is < 7.0%.
Measured: Change from Baseline at Week 12 and Week 24
Quality of Life (SF-12)
Assessed using the 12-Item Short Form Health Survey (SF-12). The survey covers eight domains summarized into two composite scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Scores range from 0 to 100, with higher scores indicating better quality of life.
Measured: Change from Baseline at Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start23 Feb 2026
- Primary completion15 May 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- yueh chu wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yueh chu wu, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398495
- Sponsor's protocol ID
- CSH-2026-A-036
- Status last verified
- Mar 2026
- First submitted
- 4 Feb 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu YC, Liao LN, Lai YF, Huang HE, Liao WC, Huang CN. Sustained and attenuated effects of transitioning from supervised to self-managed resistance training in older adults with type 2 diabetes and sarcopenia: a randomized controlled trial. Acta Diabetol. 2026 Jul 13. doi: 10.1007/s00592-026-02736-y. Online ahead of print.
PubMed 42440096
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multimodal Training on Muscle Function and Glucose Metabolism in Middle-Aged and Older Adults With Type 2 Diabetes Mellitus and Sarcopenia
- ClinicalTrials.gov ID
- NCT07398495
- Acronym / sponsor ID
- CSH-2026-A-036
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Sarcopenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- yueh chu wuUniversity, hospital or other
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 10 Feb 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 study aims to investigate the effects of a 12-week multimodal exercise intervention on middle-aged and older adults (aged 45~85 years) with Type 2 Diabetes Mellitus (T2DM). The program combines supervised training, home-based sessions, and digital support to improve muscle function, physical performance, metabolic control, and quality of life.
Detailed description
Middle-aged and older adults with T2DM, particularly in Asian populations, face a heightened risk of sarcopenia. This condition leads to a decline in muscle mass and function, negatively impacting quality of life. Effective interventions are urgently needed to slow disease progression. This randomized controlled trial will recruit 128 adults. Participants will be randomly assigned to either a control group or an intervention group. The intervention involves a multimodal exercise program and educational materials, while the control group receives standard health education. Assessments will be conducted at baseline, week 12, and week 24 to evaluate physical function, sarcopenia risk, metabolic control, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Multimodal Exercise) | Experimental | Behavioral: Multimodal Exercise Program• Arm Description: Participants in this group will engage in a 12-week multimodal exercise program. The program includes supervised training sessions, home-based exercises, and digital support. They will also receive a "Diabetes and Muscle Health Handbook" to guide their training. |
| Control Group (Standard Care) | No intervention | –Participants in this group will serve as the control. They will receive a "Nutrition and Muscle Health Education Sheet" at the beginning of the study. They will not participate in the multimodal exercise program and will continue with their routine health management based on existing medical advice. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with both Type 2 Diabetes Mellitus (T2DM) and sarcopenia.
- Maintained on a stable regimen of oral hypoglycemic agents.
- Aged 45 years or older.
- Capable of communicating effectively in Mandarin or Taiwanese.
- Willing to provide informed consent or have it obtained from a legally authorized representative.
Key exclusion criteria (5 listed)
- • Limited limb or joint function that prevents exercise (e.g., recent fractures or dislocations).
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 |
|---|---|---|
| Multimodal Exercise ProgramAlso: Control GroupParticipants will engage in a 12-week multimodal exercise program comprising supervised training sessions, home-based exercises, and digital support. To facilitate adherence and proper technique, participants will also receive a "Diabetes and Muscle Health Handbook" as a training guide. | Behavioural | Intervention Group (Multimodal Exercise) |
Primary outcome
Physical Function (5TSTS)
Time frame: Change from Baseline at Week 12 and Week 24
The Five-Times Sit-to-Stand Test (5TSTS) assesses lower limb muscle power. Participants are asked to stand up and sit down five times as quickly as possible with arms folded. The time to completion is recorded in seconds and analyzed as a continuous variable. According to the 2019 Asian Working Group for Sarcopenia (AWGS) consensus, a completion time of ≥ 12 seconds is considered abnormal and indicates low physical performance.
Handgrip Strength (HGS)
Time frame: Change from Baseline at Week 12 and Week 24
Handgrip strength (HGS) is assessed using a digital dynamometer (e.g., Jamar or an equivalent device). During the assessment, participants stand with their testing arm fully extended. Two consecutive trials are performed for each hand, and the maximum grip strength value (in kilograms) is selected for data analysis. Based on the 2019 Asian Working Group for Sarcopenia (AWGS) consensus, low muscle strength is defined as < 28 kg for men and < 18 kg for women
Skeletal Muscle Mass Index (SMI)
Time frame: Change from Baseline at Week 12 and Week 24
Determined by bioelectrical impedance analysis (BIA). Appendicular skeletal muscle mass (ASM, kg) is calculated as the sum of lean mass from both arms and legs. SMI is expressed as ASM divided by height squared (kg/m²). Low muscle mass is defined according to AWGS 2019 cut-off values (<7.0 kg/m² for men and <5.7 kg/m² for women).
Sarcopenia Risk: Assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire combined with calf circumference measurement (SARC-CalF).
Time frame: Change from Baseline at Week 12 and Week 24
Assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire combined with calf circumference measurement (SARC-CalF). The SARC-F assesses 5 items scored 0-10. A calf circumference ≤34 cm (men) or ≤33 cm (women) adds 10 points. Total SARC-CalF scores range from 0 to 20. Higher scores indicate a higher risk of sarcopenia (a worse outcome). A total SARC-CalF score ≥11 indicates a high risk.
2 secondary outcomes
Glycated Hemoglobin (HbA1c)
Time frame: Change from Baseline at Week 12 and Week 24
Quality of Life (SF-12)
Time frame: Change from Baseline at Week 12 and Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Derived from this study: PubMed 42440096Wu YC, Liao LN, Lai YF, Huang HE, Liao WC, Huang CN. Sustained and attenuated effects of transitioning from supervised to self-managed resistance training in older adults with type 2 diabetes and sarcopenia: a randomized controlled trial. Acta Diabetol. 2026 Jul 13. doi: 10.1007/s00592-026-02736-y. Online ahead of print.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Exercise Program in people with Type 2 Diabetes Mellitus (T2DM) and Sarcopenia, run by yueh chu wu at 1 site in Taiwan.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 30 Mar 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yueh chu wu WU YUEH CHU (886-952680613, yueh.chu46240@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Function (5TSTS) (time frame: Change from Baseline at Week 12 and Week 24). 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 NCT07398495, which also lists 1 linked publication.
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 30 Mar 2026.