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TerminatedNCT03456271Updated Mar 21, 2022

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

An observational study in Type 2 Diabetes Mellitus and Fragility Fractures, sponsored by Zhujiang Hospital. Terminated at 5 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-21.

Sponsored by Zhujiang Hospital · Observational

Why this study was terminated
limited Patient recruitment
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
99
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus and Fragility Fractures
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
99 participants (actual)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • fracture group
  • non-fracture group
05

What researchers measure

Primary outcomes

  1. fracture

    the participants happen to fracture

    Time frame: 3 years

06

Study locations

5 sites
  • Baiyun Community Taihe Town
    Guangzhou, Guangdong 510000, China
  • Guangzhou No.12 People's Hospital
    Guangzhou, Guangdong 510000, China
  • Haizhu Changgang Community
    Guangzhou, Guangdong 510000, China
  • Tianhe Community
    Guangzhou, Guangdong 510000, China
  • Zhujiang Hospital
    Guangzhou, Guangdong 510000, China
07

Registry details

Key details

Study ID
NCT03456271
Lead sponsor
Zhujiang Hospital
Responsible party
Sponsor
First posted
Mar 7, 2018
Start date
Jul 1, 2017
Primary completion
Nov 30, 2021
Completion
Dec 31, 2021
Last update
Mar 21, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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