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Study on the Efficacy and Safety Evaluation of the Method of Invigorating Qi and Spleen with Promoting Blood Circulation in the Intervention of Diabetic Sacropenia

Study on the Efficacy and Safety Evaluation of the Method of Invigorating Qi and Spleen with Promoting Blood Circulation in the Intervention of Diabetic Sacropenia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001255
Enrollment
Unknown
Registered
2025-06-23
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic sarcopenia

Interventions

Control group:Basic treatment
Placebo group:Basic treatment + placebo
Traditional Chinese Medicine group:Basic treatment + the prescription for invigorating qi and spleen with promoting blood circulation

Sponsors

The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Aged between 60 and 75 years old; (2) Meeting the diagnostic criteria for T2DM and the basic treatment does not include drugs that have a clear impact on skeletal muscles; (3) Meeting the diagnostic criteria for sarcopenia; (4) Being able to communicate normally walk independently without the use of assistive devices and cooperate with the doctor's treatment; (5) Those who volunteer to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Exclude patients with a history of diseases affecting muscle function including but not limited to a history of stroke stent implantation pacemaker implantation severe skeletal joint or neuromuscular diseases mental illnesses(1)(); (2)3; (3)3111/IV; (4)(22); (5)3; a history of metal implants or malignancies thyroid dysfunction severe diabetic complications (such as renal failure diabetic retinopathy diabetic foot etc.) patients who have undergone weight - loss surgery or lower - limb surgery. (2) Patients who have visited a doctor or been hospitalized due to ketoacidosis or other acute diabetic complications in the past three months. (3) Patients who have experienced acute myocardial infarction New York Heart Association class III/IV heart failure cerebral infarction and intracerebral hemorrhage in the past three months. (4) Patients with impaired liver and kidney function (transaminases greater than 2 times the upper limit of the normal reference range chronic kidney disease stage 2 or above). (5) Patients who have participated in other clinical studies in the past three months.

Design outcomes

Primary

MeasureTime frame
Physical function;Appendicular muscle mass;Muscle strength;

Secondary

MeasureTime frame
Berg balance scale;Sarcopenia quality of life questionnaire;Muscle quality;Assessment of glucose metabolism;

Countries

China

Contacts

Public ContactWen Zhong

The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

zhongwenzwcd@163.com+86 186 0280 7984

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026