Type 2 Diabetes Mellitus Complicated with Osteoporosis
Conditions
Interventions
Observation Group:Diabetes Foundational Therapy Combined with Oral Calcium Carbonate D3 Treatment and Tian Gui San Acupoint Application?
Control Group:Diabetes Foundational Therapy Combined with Oral Calcium Carbonate D3 Treatment?
Sponsors
Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: Age and Gender?? Aged 45–75 years regardless of gender. ??Diagnostic Criteria?? ??Western Medicine Diagnosis?? ??Type 2 Diabetes Mellitus (T2DM):?? According to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus (2020): Presence of classic diabetic symptoms (e.g. polyuria polydipsia polyphagia and unexplained weight loss) ??AND?? Random plasma glucose =11.1 mmol/L ??OR?? Fasting plasma glucose (FPG) =7.0 mmol/L ??OR?? 2-hour postprandial glucose (2hPG) during oral glucose tolerance test (OGTT) =11.1 mmol/L ??OR?? Glycated hemoglobin (HbA1c) =6.5%. ??T2DM Complicated with Osteoporosis:?? Based on the Primary Osteoporosis Diagnosis and Treatment Guidelines (2017): Meets the above T2DM diagnostic criteria ??AND?? Bone mineral density (BMD) T-score = -2.5 ??OR?? History of fragility fracture ??OR?? Positive response to calcium supplementation or anti-osteoporotic medications ??OR?? Confirmation by imaging studies. ??Traditional Chinese Medicine (TCM) Syndrome Diagnosis?? ??Spleen-Kidney Deficiency Syndrome?? (): Defined by the Guiding Principles for Clinical Research of New Chinese Medicines (Trial) for "Xiaoke" (consumptive thirst) and osteoporosis including: Symptoms: Fatigue soreness of waist and knees polyuria dry mouth loose stools. Tongue and pulse: Pale tongue with thin white coating; deep and weak pulse. ??Medication History?? No use of glucocorticoids or other medications affecting bone metabolism (e.g. bisphosphonates teriparatide) within the past 12 weeks. ??Informed Consent?? Voluntarily participates in the study and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: Secondary Osteoporosis?? Patients with secondary osteoporosis caused by endocrine disorders (e.g., thyroid, parathyroid, adrenal, gonadal, or pituitary gland diseases). ??Recent Use of Bone-Modifying Medications?? Patients who have taken medications affecting bone metabolism within the past 12 weeks, including: ??Sex hormones?? (e.g., estrogen, testosterone); ??Analgesics?? (e.g., long-term NSAIDs, opioids); ??Other??: Bisphosphonates, denosumab, or teriparatide. ??Recent Fractures?? Patients with fractures occurring within the last 3 months (verified by X-ray or MRI). ??Severe Skeletal Destruction?? Patients with advanced skeletal lesions (e.g., widespread osteolysis, metastatic bone disease) rendering them functionally disabled. ??Organ Dysfunction?? ??Hepatic impairment??: Child-Pugh Class C or ALT/AST > 3× upper limit of normal (ULN); ??Renal impairment??: eGFR 2.5 mg/dL. ??Pregnancy or Lactation?? Women who are pregnant, breastfeeding, or planning pregnancy during the study period. ??Hypersensitivity?? Patients with known allergies to Tian Gui San components (e.g., Psoralea corylifolia, Cistanche deserticola) or acupoint patch materials (e.g., medical adhesives). ??Poor Compliance?? Patients unable to complete the 12-week treatment course due to geographic mobility, cognitive impairment, or refusal to follow protocols (anticipated loss to follow-up >20%).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Syndrome Score Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analog Scale (VAS)?;bone mineral density;Blood Glucose Indicators Bone Turnover Markers Insulin-like Growth Factor (IGF); | — |
Countries
China
Contacts
Public ContactLin Xiaosheng
Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine?
Outcome results
None listed