Construction of the "undiseased" status bank for type 2 diabetes mellitus complicated with osteoporosis
| ISRCTN | ISRCTN47827392 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47827392 |
| Secondary identifying numbers | NSFC-T2341023 |
- Submission date
- 15/06/2024
- Registration date
- 19/06/2024
- Last edited
- 04/08/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Type 2 diabetes mellitus combined with osteoporosis (T2DM-OP) has a high prevalence rate and high disability/death rate, and the bone mass level of patients is an important marker of the evolution and development of this disease. Early identification of the stage of T2DM-bone loss is an important strategy to prevent T2DM-OP. The study aims to screen the identifiable and quantifiable clinical phenotypes and key molecules of the "undiseased" state of T2DM-OP, and construct a mathematical model reflecting the critical transition of "the undiseased" in T2DM-OP to reveal the internal change leading to the occurrence and development of the disease.
Who can participate?
Patients aged 45 to 80 years old with type 2 diabetes mellitus
What does the study involve?
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 biological samples will be collected, including: general demographic information (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); complications and main drug use; number of fractures; traditional Chinese medicine (TCM) syndrome judgment; grip strength and sitting and standing test time; bone density (lumbar spine and hip bone density) and skeletal muscle mass. 10 ml blood will be collected from participants fasting in the morning to detect bone, glucose and lipid metabolism related markers and cytokines.
What are the possible benefits and risks of participating?
Participants may benefit from this study, including better assessment and monitoring of blood glucose and bone mass to inform clinical decision-making. They can also get reasonable and standardized clinical decision-making advice and improve their quality of life.
The study was an observational study and participants underwent routine medical practices with risks similar to those of a daily physical examination, so it did not pose any risks outside of routine medical treatment.
Where is the study run from?
Wangjing Hospital of China Academy of Chinese Medical Sciences (China)
When is the study starting and how long is it expected to run for?
January 2024 to December 2026
Who is funding the study?
National Natural Science Foundation of China (T2341023) (China)
Who is the main contact?
1. Prof. Xu Wei, weixu.007@163.com
2. Dr Chuanrui Sun, Sunchuanrui619@163.com
Contact information
Principal Investigator
No. 6 South Zhonghuan Road
Chaoyang District
Beijing
100102
China
 ORCID ID |
0000-0001-6723-9604 |
|---|---|
| Phone | +86 (0)13488716557 |
| weixu.007@163.com |
Public, Scientific
No. 6 South Zhonghuan Road
Chaoyang District
Beijing
100102
China
| ORCID ID |
0000-0003-0185-0499 |
|---|---|
| Phone | +86 (0)18800109771 |
| sunchuanrui619@163.com |
Study information
| Study design | Observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Community, Hospital |
| Study type | Prevention, Screening |
| Scientific title | Study on "undiseased" status characterization and critical warning mechanism of type 2 diabetes mellitus complicated with osteoporosis |
| Study acronym | DECODE-TOP |
| Study objectives | 1. To screen the identifiable and quantifiable clinical phenotypes and key molecules of the "undiseased" state of type 2 diabetes mellitus combined with osteoporosis. 2. To construct a mathematical model reflecting the critical transition of the "undiseased" in type 2 diabetes mellitus combined with osteoporosis, and reveal the internal change law leading to the occurrence and development of the disease. |
| Ethics approval(s) |
Approved 22/05/2024, Medical Ethics Committee of Wangjing Hospital, China Academy of Chinese Medical Sciences (No.6 South Zhonghuan Road, Chaoyang District, Beijing, 100102, China; +86 (0)10-84739223; wjyyec@126.com), ref: WJEC-KT-2024-035-P001 |
| Health condition(s) or problem(s) studied | Type 2 diabetes mellitus complicated with osteoporosis |
| Intervention | 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 biological samples will be collected, mainly including: 1. General demographic information (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 3. The number of fractures 4. TCM syndrome judgment 5. Grip strength and 5 times sitting and standing test time 6. Bone density (focus on monitoring lumbar spine and hip bone density) and skeletal muscle mass 7. 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. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 01/01/2024 |
| Completion date | 30/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 45 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 1000 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 17/10/2024 |
| Date of final enrolment | 01/07/2026 |
Locations
Countries of recruitment
- China
Study participating centres
Chaoyang District
Beijing
100102
China
Niangxi Town
Xinshao County
Shaoyang City
422900
China
Xihu Wolong District
Nanyang City
473000
China
Nankai District
Tianjin
300100
China
Kuiwen District
Weifang City
261041
China
Sponsor information
Government
No. 83, Shuangqing Road
Haidian District
Beijing
100085
China
| Phone | +86 (0)10 62327096 |
|---|---|
| interdis@nsfc.gov.cn | |
| Website | http://www.nsfc.gov.cn/publish/portal1/ |
"ROR" |
https://ror.org/01h0zpd94 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Results and Publications
| Intention to publish date | 01/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | 1. The study protocol will be submitted to a peer-reviewed journal 2. The results will be submitted to a peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
04/08/2025: The following changes were made to the study record:
1. The study acronym was changed from TOP to DECODE-TOP.
2. The completion date was changed from 01/05/2027 to 30/12/2026.
3. The primary outcome measures were updated.
4. The study participating centres were updated to remove Eye Hospital, China Academy of Chinese Medical Sciences, The Third Affiliated Hospital of Zhejiang Chinese Medicine University (Zhejiang Provincial Zhongshan Hospital), and Donga County People's Hospital, and add Zhengda Shaoyang Orthopaedic Hospital, Nanyang Orthopaedic Hospital, Nankai District Hospital of Traditional Chinese Medicine, and Weifang People's Hospital.
5. The date of first enrolment was changed from 01/07/2024 to 17/10/2024.
18/06/2024: Study's existence confirmed by the Medical Ethics Committee of Wangjing Hospital, China Academy of Chinese Medical Sciences.
