Metformin in Elderly Patients With Type 2 Diabetes and Muscle Strength, Muscle Mass, and Physical Function: Positive or Negative Correlation?

NCT07788378 | Completed

• 1 other identifier: 2025K371
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabete Type 2; Muscle Mass; Muscle Strength; Physical Function; Metformin

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  at least 3 months

Study Arms (2)

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.

Drug: Metformin

Interventions

Metformin DRUG

Older patients with type 2 diabetes have a history of using metformin for at least 3 months.

metformin

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Huadong Hospital, Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 26, 2026
• Study Start: November 11, 2024
• Primary Completion: December 24, 2024
• Study Completion: December 24, 2024
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

CN (1)