Intervention effect and mechanism of total flavonoids of Tartary buckwheat on bone loss in type 2 diabetes mellitus

A randomized, double-blind, placebo, multicenter clinical study of total flavonoids from Tartary buckwheat in the intervention of bone loss in type 2 diabetes mellitus

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400086439

Enrollment

Unknown

Registered

2024-07-01

Start date

2024-07-01

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

Bone loss in type 2 diabetes

Interventions

intervention group:Take buckwheat tea (high flavonoid rutin whole plant tea) orally every day, drink 1 tea bag from 10:00 to 14:00, 200ml each time. Rutin whole plant buckwheat tea, the main component

placebo group:Take placebo floating wheat tea orally every day, drink one tea bag from 10:00 to 14:00, 200ml each time. Manufacturer: Anguo Baicao margin business department. Product number: 100765466

Eligibility

Sex/Gender

All

Age

30 Years to 50 Years

Inclusion criteria

Inclusion criteria: ? Patients with type 2 diabetes taking metformin; ? The results of lumbar 1-4 (L1-4) or femoral neck test showed Z-value =-2.0; (3) There were no severe scoliosis, bone trauma, lumbar or hip implants, or sequelae of orthopedic surgery that affected the measurement; The compression fracture of lumbar vertebra does not exceed 1 vertebra; ? You can follow the doctor's advice and take Tartary buckwheat whole-plant tea on time; ? Willing to accept follow-up and monitoring.

Exclusion criteria

Exclusion criteria: ? Serious cardiovascular and cerebrovascular diseases/hematopoietic system diseases and other internal diseases, liver and kidney function abnormalities (ALT and AST are more than 1.5 times the upper limit of normal, and blood creatinine is greater than the upper limit of normal); ? Pregnant women, menopausal women, patients with stomach diseases, allergic constitution; ? Patients with mental illness, paralysis or senile dementia; And those who have received osteoporosis medications (excluding calcium and vitamin D supplements) or other medications that may affect bone calcium metabolism in the last 6 months; ? Patients with hypocalcemia and vitamin D deficiency.

Design outcomes

Primary

Measure	Time frame
BMD(bone mineral density);Urine non-targeted metabolomics;	—

Secondary

Measure	Time frame
Serum 25-OHVD;Serum PTH;Serum OCN;Serum P1NP;Serum ß-CTX;Serum ALP;serium inorganic phosphorus;serum calcium;	—

Countries

China

Contacts

Public ContactJiangYan

North China University of Science and Technology

54509527@qq.com+86 315 881 9018

Outcome results

None listed

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