Diabete Type 2NCT07788378
Metformin in Elderly Patients With Type 2 Diabetes and Muscle Strength, Muscle Mass, and Physical Function: Positive or Negative Correlation?
An observational study of Diabete Type 2 and Muscle Strength, run by Fudan University at 1 site in China.
Trial summary
With the accelerating aging process in China, sarcopenia has drawn increasing attention. Sarcopenia is an age-related geriatric syndrome characterized by reductions in muscle mass, muscle strength, and/or physical function. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diabete Type 2, Muscle Strength, Muscle Mass
- What is being tested?
- Metformin
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2024to 24 Dec 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elderly patients with type 2 diabetes hospitalized at the Department of Endocrinology, Huadong Hospital affiliated to Fudan University, from August 1, 2018, to August 31, 2023, were enrolled. Inclusion criteria: (1) age ≥ 60 years; (2) diagnosed with type 2 diabetes; (3) stable glucose-lowering regimen for at least three months prior to admission; (4) completed Bioelectrical Impedance Analysis (BIA), grip strength, and gait speed assessments;(5) The reason for hospitalization was to regulate blood glucose. Exclusion criteria: (1) diabetic ketoacidosis or hyperosmolar coma; (2) severe hepatic, renal, or cardiopulmonary dysfunction, or severe gastrointestinal disease; (3) active malignant tumors; (4) use of glucocorticoids or antipsychotic drugs; (5) active infectious diseases; (6) severe musculoskeletal diseases.
Who may be able to join
- age ≥ 60 years;
- diagnosed with type 2 diabetes;
- stable glucose-lowering regimen for at least three months prior to admission;
- completed Bioelectrical Impedance Analysis (BIA), grip strength, and gait speed assessments;
- The reason for hospitalization was to regulate blood glucose;
Who cannot join
- diabetic ketoacidosis or hyperosmolar coma;
- severe hepatic, renal, or cardiopulmonary dysfunction, or severe gastrointestinal disease;
- active malignant tumors;
- use of glucocorticoids or antipsychotic drugs;
- active infectious diseases;
- severe musculoskeletal diseases;
Trial locations and contacts
1 site in 1 country.
About this study
With the accelerating aging process in China, sarcopenia has drawn increasing attention. Sarcopenia is an age-related geriatric syndrome characterized by reductions in muscle mass, muscle strength, and/or physical function. Sarcopenia has a high prevalence, often insidious onset, and broad impacts on physiological functions. According to the 2019 report from the Asian Working Group for Sarcopenia (AWGS), sarcopenia prevalence among elderly Asians ranged from 5.5% to 25.7%, with males exhibiting higher rates (5.1% to 21.0%) than females (4.1% to 16.3%). Particularly among patients with diabetes, sarcopenia incidence was significantly elevated, with a prevalence of 14.8% reported in Chinese diabetic populations.
Sarcopenia exerts numerous adverse effects. Sarcopenia is strongly associated with adverse cardiovascular events and increased mortality. Sarcopenia is linked to cancer and significantly elevates the risk of various postoperative complications in patients with gastrointestinal malignancies, including dysphagia, cognitive impairment, fractures, falls, hospitalization, and all-cause mortality. Sarcopenia and diabetes frequently coexist within the same individual, leading to multiple adverse outcomes. Sarcopenia results in declining in function flexibility and responsiveness in diabetic patients, causing gait alterations and impaired balance, limiting daily activities, and is closely linked to risks of falls, fractures, depression, frailty, and mortality. Thus, it is critically important to treat sarcopenia alongside diabetes and avoid detrimental effects of hypoglycemic drugs on muscle.
Read more
Metformin lowers blood glucose by increasing muscle glucose uptake, inhibiting hepatic glucose output and gluconeogenesis, and promoting glucose excretion into the intestinal lumen; it also reduces the risk of diabetic cardiovascular disease, diabetic retinopathy, nephropathy, and neuropathy.
There remains controversy in current studies regarding metformin's impact on sarcopenia. Some studies indicate that metformin may have potential beneficial effects on grip strength, skeletal muscle mass, and gait speed. Nordklint AK reported that after 18 months of metformin intervention in patients with type 2 diabetes, bone mineral content and density were improved. Qaisar R conducted a 16-week metformin trial on older men, finding improvements in grip strength and gait speed with statistical significance (P < 0.05). Klimova AV found that a 6-month metformin intervention improved physical function in patients. Lyu Q's murine study demonstrated that 5 months of metformin treatment conferred benefits and recovery effects on the gastrocnemius muscle in sarcopenia models. Conversely, some studies indicate no impact of metformin on muscle mass, grip strength, or gait speed. Qaisar R reported no improvement in body composition or gait speed after 4 months of metformin use. Laksmi PW found no significant difference in grip strength between groups after a 16-week metformin intervention. Koshizaka M reported that after 24 weeks of intervention with ipragliflozin or metformin in patients with type 2 diabetes, metformin had no significant effect on muscle mass. Previous studies have also elucidated mechanisms underlying metformin's effects on muscle. According to Kang MJ, metformin induced myostatin expression in skeletal muscle cells via the Adenosine5'-monophosphate-activated protein kinase (AMPK)-FoxO3a-HDAC6 pathway, thereby impairing muscle function. Other studies found that metformin reduced expression of mTORC1-related genes in muscles of elderly individuals with impaired glucose tolerance, potentially leading to decreased muscle protein synthesis or increased autophagy.
Therefore, this study enrolled elderly patients with type 2 diabetes and employed a cross-sectional design with propensity score matching to elucidate the association between metformin and muscle strength, muscle mass, and physical function, providing evidence for rational clinical use of hypoglycemic drugs.
- Conditions
- Diabete Type 2, Muscle Strength, Muscle Mass, Physical Function, Metformin
- Being tested
- Metformin
- 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.
MetforminDrug
Older patients with type 2 diabetes have a history of using metformin for at least 3 months.
| Study group | Role | What they receive |
|---|---|---|
| control | The elderly patients with type 2 diabetes have no history of using metformin for at least the past 3 months. | |
| metformin | Older patients with type 2 diabetes have a history of using metformin for at least 3 months. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
grip strength
This study included elderly patients with type 2 diabetes who had been consistently taking hypoglycemic drugs for more than three months. They were divided into the metformin group and the non-metformin group, and the difference in grip strength between the two groups at this time was compared.
Measured: at least 3 months
gait speed
This study included elderly patients with type 2 diabetes who had been consistently taking hypoglycemic drugs for more than three months. They were divided into the metformin group and the non-metformin group, and the difference in gait speed between the two groups at this time was compared.
Measured: at least 3 months
Appendicular skeletal muscle mass
This study included elderly patients with type 2 diabetes who had been consistently taking hypoglycemic drugs for more than three months. They were divided into the metformin group and the non-metformin group, and the difference in Appendicular skeletal muscle mass between the two groups at this time was compared.
Measured: at least 3 months
relative skeletal muscle mass
This study included elderly patients with type 2 diabetes who had been consistently taking hypoglycemic drugs for more than three months. They were divided into the metformin group and the non-metformin group, and the difference in relative skeletal muscle mass(Appendicular skeletal muscle mass/height^2) between the two groups at this time was compared.
Measured: at least 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start11 Nov 2024
- Primary completion24 Dec 2024
- Study completion24 Dec 2024
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 Diabete Type 2Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Lu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788378
- Sponsor's protocol ID
- 2025K371
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wei C, Qiu J, Xue M, Lu B, Jiang C, Tao X. Metformin in Elderly Patients With Type 2 Diabetes and Muscle Strength, Muscle Mass, and Physical Function: Positive or Negative Correlation? Int J Endocrinol. 2026 Oct 1;2026:6423817. doi: 10.1155/ije/6423817. eCollection 2026.
PubMed 42825099
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin in Elderly Patients With Type 2 Diabetes and Muscle Strength, Muscle Mass, and Physical Function: Positive or Negative Correlation?
- ClinicalTrials.gov ID
- NCT07788378
- Acronym / sponsor ID
- 2025K371
- Conditions
- Diabete Type 2, Muscle Strength, Muscle Mass, Physical Function, Metformin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 24 Dec 2024 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 26 Aug 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.
With the accelerating aging process in China, sarcopenia has drawn increasing attention. Sarcopenia is an age-related geriatric syndrome characterized by reductions in muscle mass, muscle strength, and/or physical function. Sarcopenia has a high prevalence, often insidious onset, and broad impacts on physiological functions. According to the 2019 report from the Asian Working Group for Sarcopenia (AWGS), sarcopenia prevalence among elderly Asians ranged from 5.5% to 25.7%, with males exhibiting higher rates (5.1% to 21.0%) than females (4.1% to 16.3%). Particularly among patients with diabetes, sarcopenia incidence was significantly elevated, with a prevalence of 14.8% reported in Chinese diabetic populations.
Sarcopenia exerts numerous adverse effects. Sarcopenia is strongly associated with adverse cardiovascular events and increased mortality. Sarcopenia is linked to cancer and significantly elevates the risk of various postoperative complications in patients with gastrointestinal malignancies, including dysphagia, cognitive impairment, fractures, falls, hospitalization, and all-cause mortality. Sarcopenia and diabetes frequently coexist within the same individual, leading to multiple adverse outcomes. Sarcopenia results in declining in function flexibility and responsiveness in diabetic patients, causing gait alterations and impaired balance, limiting daily activities, and is closely linked to risks of falls, fractures, depression, frailty, and mortality. Thus, it is critically important to treat sarcopenia alongside diabetes and avoid detrimental effects of hypoglycemic drugs on muscle.
Metformin lowers blood glucose by increasing muscle glucose uptake, inhibiting hepatic glucose output and gluconeogenesis, and promoting glucose excretion into the intestinal lumen; it also reduces the risk of diabetic cardiovascular disease, diabetic retinopathy, nephropathy, and neuropathy.
There remains controversy in current studies regarding metformin's impact on sarcopenia. Some studies indicate that metformin may have potential beneficial effects on grip strength, skeletal muscle mass, and gait speed. Nordklint AK reported that after 18 months of metformin intervention in patients with type 2 diabetes, bone mineral content and density were improved. Qaisar R conducted a 16-week metformin trial on older men, finding improvements in grip strength and gait speed with statistical significance (P < 0.05). Klimova AV found that a 6-month metformin intervention improved physical function in patients. Lyu Q's murine study demonstrated that 5 months of metformin treatment conferred benefits and recovery effects on the gastrocnemius muscle in sarcopenia models. Conversely, some studies indicate no impact of metformin on muscle mass, grip strength, or gait speed. Qaisar R reported no improvement in body composition or gait speed after 4 months of metformin use. Laksmi PW found no significant difference in grip strength between groups after a 16-week metformin intervention. Koshizaka M reported that after 24 weeks of intervention with ipragliflozin or metformin in patients with type 2 diabetes, metformin had no significant effect on muscle mass. Previous studies have also elucidated mechanisms underlying metformin's effects on muscle. According to Kang MJ, metformin induced myostatin expression in skeletal muscle cells via the Adenosine5'-monophosphate-activated protein kinase (AMPK)-FoxO3a-HDAC6 pathway, thereby impairing muscle function. Other studies found that metformin reduced expression of mTORC1-related genes in muscles of elderly individuals with impaired glucose tolerance, potentially leading to decreased muscle protein synthesis or increased autophagy.
Therefore, this study enrolled elderly patients with type 2 diabetes and employed a cross-sectional design with propensity score matching to elucidate the association between metformin and muscle strength, muscle mass, and physical function, providing evidence for rational clinical use of hypoglycemic drugs.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | –The elderly patients with type 2 diabetes have no history of using metformin for at least the past 3 months. |
| metformin | – | Drug: MetforminOlder patients with type 2 diabetes have a history of using metformin for at least 3 months. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly patients with type 2 diabetes hospitalized at the Department of Endocrinology, Huadong Hospital affiliated to Fudan University, from August 1, 2018, to August 31, 2023, were enrolled. Inclusion criteria: (1) age ≥ 60 years; (2) diagnosed with type 2 diabetes; (3) stable glucose-lowering regimen for at least three months prior to admission; (4) completed Bioelectrical Impedance Analysis (BIA), grip strength, and gait speed assessments;(5) The reason for hospitalization was to regulate blood glucose. Exclusion criteria: (1) diabetic ketoacidosis or hyperosmolar coma; (2) severe hepatic, renal, or cardiopulmonary dysfunction, or severe gastrointestinal disease; (3) active malignant tumors; (4) use of glucocorticoids or antipsychotic drugs; (5) active infectious diseases; (6) severe musculoskeletal diseases.
Key inclusion criteria (5 listed)
- age ≥ 60 years;
- diagnosed with type 2 diabetes;
- stable glucose-lowering regimen for at least three months prior to admission;
- completed Bioelectrical Impedance Analysis (BIA), grip strength, and gait speed assessments;
- The reason for hospitalization was to regulate blood glucose;
Key exclusion criteria (6 listed)
- diabetic ketoacidosis or hyperosmolar coma;
- severe hepatic, renal, or cardiopulmonary dysfunction, or severe gastrointestinal disease;
- active malignant tumors;
- use of glucocorticoids or antipsychotic drugs;
- active infectious diseases;
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 |
|---|---|---|
| MetforminOlder patients with type 2 diabetes have a history of using metformin for at least 3 months. | Drug | metformin |
Primary outcome
grip strength
Time frame: at least 3 months
This study included elderly patients with type 2 diabetes who had been consistently taking hypoglycemic drugs for more than three months. They were divided into the metformin group and the non-metformin group, and the difference in grip strength between the two groups at this time was compared.
gait speed
Time frame: at least 3 months
This study included elderly patients with type 2 diabetes who had been consistently taking hypoglycemic drugs for more than three months. They were divided into the metformin group and the non-metformin group, and the difference in gait speed between the two groups at this time was compared.
Appendicular skeletal muscle mass
Time frame: at least 3 months
This study included elderly patients with type 2 diabetes who had been consistently taking hypoglycemic drugs for more than three months. They were divided into the metformin group and the non-metformin group, and the difference in Appendicular skeletal muscle mass between the two groups at this time was compared.
relative skeletal muscle mass
Time frame: at least 3 months
This study included elderly patients with type 2 diabetes who had been consistently taking hypoglycemic drugs for more than three months. They were divided into the metformin group and the non-metformin group, and the difference in relative skeletal muscle mass(Appendicular skeletal muscle mass/height^2) between the two groups at this time was compared.
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 26 Aug 2026.
- Derived from this study: PubMed 42825099Wei C, Qiu J, Xue M, Lu B, Jiang C, Tao X. Metformin in Elderly Patients With Type 2 Diabetes and Muscle Strength, Muscle Mass, and Physical Function: Positive or Negative Correlation? Int J Endocrinol. 2026 Oct 1;2026:6423817. doi: 10.1155/ije/6423817. eCollection 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Diabete Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
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 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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?
An observational study of Diabete Type 2 and Muscle Strength, run by Fudan 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 5 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 26 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 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?
grip strength (time frame: at least 3 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 NCT07788378, 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 26 Aug 2026.