Type 2 Diabetic Osteoporosis
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Bone mineral density; | — |
Secondary
| Measure | Time 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
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine