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

Sponsor

Zhujiang Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT03456271

Collaborator

(none)

Enrollment

Locations

Actual Duration (Months)

19.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus and Fragility Fractures

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

99 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2017

Actual Primary Completion Date :

Nov 30, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
fracture group
non-fracture group

Outcome Measures

Primary Outcome Measures

fracture [3 years]
the participants happen to fracture

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baiyun Community Taihe Town	Guangzhou	Guangdong	China	510000
2	Guangzhou No.12 People's Hospital	Guangzhou	Guangdong	China	510000
3	Haizhu Changgang Community	Guangzhou	Guangdong	China	510000
4	Tianhe Community	Guangzhou	Guangdong	China	510000
5	Zhujiang Hospital	Guangzhou	Guangdong	China	510000

Sponsors and Collaborators

Zhujiang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhujiang Hospital

ClinicalTrials.gov Identifier:

NCT03456271

Other Study ID Numbers:

2017-NFMDXK-001

First Posted:

Mar 7, 2018

Last Update Posted:

Mar 21, 2022

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Fractures, Bone

Study Results

No Results Posted as of Mar 21, 2022