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A Prospective Cohort Study:Forecast Fracture Risk With a Serum Marker of Type 2 Diabetes in Guangzhou Community

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ClinicalTrials.gov Identifier: NCT03456271
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Zhujiang Hospital

Brief Summary:
The objective of this study is to find out the biochemical markers which have independent predictive value of fragility fractures risk with Type 2 diabetes in Guangzhou community and evaluate bone strength better and increase the ability of recognizing fracture risk through following-up visits the bone metabolism index like esRAGE-to-pentosidine ratio of the petients with type 2 diabetes and osteoporosis,compared with the classical fracture risk assessment instrument.

Condition or disease
Type 2 Diabetes Mellitus and Fragility Fractures

Study Type : Observational [Patient Registry]
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Prospective Cohort Study:Forecast Fracture Risk With a Serum Marker of Type 2 Diabetes in Guangzhou Community
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Group/Cohort
fracture group
non-fracture group



Primary Outcome Measures :
  1. fracture [ Time Frame: 3 years ]
    the participants happen to fracture



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
the participants were recruited from Zhujiang Hospital,Guangzhou No.12 People's Hospital,Haizhu Changgang Community,Baiyun Community Taihe Town and Tianhe Community.
Criteria

Inclusion Criteria:

  • (1) aged 18-65 years; (2) patients were diagnosed with type 2 diabetes based on the definition of diabetes of WHO in 1999.

Exclusion Criteria:

  • 1. type 1 diabetes and other specific types of diabetes; 2. diabetes related acute complications like diabetic ketoacidosis and hyperglycemic hyperosmolar status. 3. had used drugs that is known to have effect on bone(like active vitamin D, bisphosphonate, calcitonin, estrogen receptor modulators, estrogen, thiazolidinediones); 4. suffer from diseases that is known to have effect on bone (hyperthyroidism, hypothyroidism, hyperparathyroidism, hypoparathyroidism,cushing syndrome,chronic renal failure,renal tubular acidosis,osteoporosis after gastrectomy,osteoporosis caused by liver disease,rheumatoid disease,osteoporosis induced by gastrointestinal absorption dysfunction); 5. disuse osteoporosis; 6. cannot be exposure to sunlight due to skin diseases; 7. use glucocorticoids for over 3 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456271


Contacts
Contact: Li Yang, MD +86 13924207196 yangli19762009@163.com

Locations
China, Guangdong
Baiyun Community Taihe Town Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Li Yang, MD    +86 13924207196    yangli19762009@163.com   
Guangzhou No.12 People's Hospital Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Li Yang, MD    +86 13924207196    yangli19762009@163.com   
Haizhu Changgang Community Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Li Yang, MD    +86 13924207196    yangli19762009@163.com   
Tianhe Community Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Li Yang, MD    +86 13924207196    yangli19762009@163.com   
Zhujiang Hospital Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Li Yang, MD    +86 13924207196    yangli19762009@163.com   
Sponsors and Collaborators
Zhujiang Hospital

Responsible Party: Zhujiang Hospital
ClinicalTrials.gov Identifier: NCT03456271     History of Changes
Other Study ID Numbers: 2017-NFMDXK-001
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Fractures, Bone
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Wounds and Injuries