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Construction of the "undiseased" status bank for type 2 diabetes mellitus complicated with osteoporosis

Study on "undiseased" status characterization and critical warning mechanism of type 2 diabetes mellitus complicated with osteoporosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN47827392
Enrollment
1000
Registered
2024-06-19
Start date
2024-10-17
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Type 2 diabetes mellitus complicated with osteoporosis Other

Interventions

Patients with type 2 diabetes will be recruited and divided into three levels of normal bone mass, bone loss and osteoporosis through DEXA bone density detection, and clinical information and biologic

Sponsors

National Natural Science Foundation of China
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for type 2 diabetes mellitus 2. Aged 45 to 80 years old, male or female 3. Signed the informed consent, and the respondents voluntarily participated in the survey

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes mellitus and specific type diabetes mellitus 2. Patients with severe cardiovascular diseases, liver and kidney diseases, malignant tumors and other wasting diseases and infectious diseases 3. Patients with mental disorders such as Alzheimer's disease, mental illness or depression, or who are unable to cooperate with the completion of the trial 4. Patients with acute metabolic disorders such as diabetic ketoacidosis in the past 1 month 5. Patients with other diseases of the endocrine system, such as Cushing's syndrome, hyperthyroidism, hypothyroidism, etc 6. Patients taking oral or intravenous glucocorticoids, oral estrogen and progesterone replacement therapy 7. Those who are participating in other clinical trials

Design outcomes

Primary

MeasureTime frame
Current primary outcome measure as of 04/08/2025: Bone density (focus on monitoring lumbar spine and hip) and body composition analysis measured using dual-energy X-ray absorptiometry (DXA) at baseline Previous primary outcome measure: Bone density (focus on monitoring lumbar spine and hip) measured using dual-energy X-ray absorptiometry (DXA) at baseline

Secondary

MeasureTime frame
1. General demographic information is measured using a questionnaire at baseline, including gender, age, menopause, diet, lifestyle and other general social demographic information, as well as personal history, past history, family history, height, weight and other background information 2. Complications and main drug use measured using a questionnaire by way of inquiry at baseline 3. The number of fractures is measured using a questionnaire by way of inquiry at baseline 4. Traditional Chinese medicine (TCM) syndrome judgment is judged by professional traditional Chinese medicine doctors at baseline 5. Grip strength measured using dynamograph at baseline 6. The five-times-sit-to-stand test measured using timer at baseline 7. Skeletal muscle mass measured using dual-energy X-ray absorptiometry (DXA) at baseline 8. Laboratory tests (blood) using ELISA at baseline. 10 ml venous blood will be collected from the subjects in the fasting state in the morning to detect bone metabolism indexes, glucose metabolism related indexes, lipid metabolism related indexes, and cytokines.

Countries

China

Contacts

Public ContactChuanrui Sun
sunchuanrui619@163.com+86 (0)18800109771

Outcome results

None listed

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