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Combined Electroacupuncture-Medication Therapy for Osteoporosis in Type 2 Diabetes: A Multicenter Randomized Controlled Trial

"A Multicenter Randomized Controlled Study on Combined Electroacupuncture and Western Medicine Therapy for Type 2 Diabetic Osteoporosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001548
Enrollment
Unknown
Registered
2025-08-09
Start date
2026-01-05
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Type 2 Diabetic Osteoporosis

Interventions

Treatment Group:The combined treatment of electroacupuncture and Western medicine is adopted. The electroacupuncture operation is carried out by professionals who have received unified training to ens
Control Group:Western medicine treatment: The combination of acupuncture and medication group. Pseudo-electroacupuncture: Shallow puncture at non-acupoints (1.5 cun away from the acupoint, 1-3 mm shal

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Simultaneously meet the following diagnostic criteria for both traditional Chinese and Western medicine - - Western medical diagnosis: Complies with the "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2024 Edition)" and the "Guidelines for the Diagnosis and Treatment of Primary Osteoporosis (2022 Edition)". Specifically as follows: 1) Diagnosis of T2DM: Fasting blood glucose =7.0 mmol/L, or HbA1c=6.5%, or 2-hour OGTT blood glucose =11.1 mmol/L. 2) Diagnosis of osteoporosis: Bone mineral density T value of the lumbar vertebrae or hip =-2.5, or accompanied by a history of fragility fractures. - Traditional Chinese Medicine diagnosis: Consistent with the "Expert Consensus on Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Osteoporosis", symptoms include soreness and weakness in the waist and knees, bone pain, difficulty in walking, aversion to cold, cold limbs, fatigue and weakness, pale tongue with white coating, and deep and fine pulse. Syndrome differentiation and classification: It conforms to the syndrome type of "kidney deficiency and spleen weakness, meridian stasis". (2) Age: 18 to 75 years old, gender not limited. (3) The course of diabetes is =5 years, and HbA1c is 6.5%-9.0%. (4) The lifestyle was stable in the three months prior to enrollment (fluctuations in diet and exercise volume <20%). (5) No drugs that affect bone/glucose metabolism (such as thiazolidinediones, GLP-1 receptor agonists) were used. (6) Metformin had been stably used for =3 months before enrollment and agreed to maintain the original dose regimen during the study period. (7) Sign the informed consent form and commit to completing the follow-up.

Exclusion criteria

Exclusion criteria: (1) Combined with severe cardiovascular and cerebrovascular diseases (such as recent myocardial infarction, stroke). (2) Liver and kidney dysfunction (ALT/AST > 3 times the upper limit, eGFR 1200mg or vitamin D>2000IU (the supplementary dosage needs to be recorded) (4) Metformin has not been stably used, or other drugs that affect bone/glucose metabolism (such as thiazolidinediones, GLP-1 receptor agonists, insulin) have been used within the past 3 months. (5) Take traditional Chinese medicine preparations that tonify kidney Yang. (6) Pregnant or lactating women, those with a history of malignant tumors, or those with mental disorders who are unable to cooperate with treatment. (7) History of fainting from acupuncture or skin infection makes it impossible to receive acupuncture treatment.

Design outcomes

Primary

MeasureTime frame
Bone mineral density;

Secondary

MeasureTime frame
Bone-Alkaline Phosphatase,Bone-Specific Alkaline Phosphatase,Beta CrossLaps;Glycated Hemoglobin; C-Reactive Protein, Tumor Necrosis Factor-alpha;TCM syndrome score;SF-36 Quality of Life Survey;

Countries

People's Republic of China

Contacts

Public ContactYin Shou

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

33359879@qq.com0086-13818008155

Outcome results

None listed

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