- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01846533
Osteoprosis in Type 2 Diabetic Patients- a Cohort Study
July 28, 2015 updated by: National Taiwan University Hospital
Some possible humoural and cellular mechanism for diabetes related osteoporosis/fractures were proposed and summarzied as the following, (1)Diabetes mellitus increases osteoclast function but decreases osteoblast function, thereby leading to accelerated bone loss, osteopenia and osteoporosis.
(2)DM/hyperglycemia induces production of macrophage colony stimulating factor (MCSF), tumor necrosis factor (TNF)-α and receptor activator of nuclear factor-κB ligand (RANKL), all of which are osteoblast-derived activators of osteoclast proliferation and differentiation.
(3) DM/hyperglycemia suppresses osteoblast proliferation and function, in part, by decreasing runtrelated transcription factor (Runx)-2, osteocalcin and osteopontin expressions.
(4)Adipogenic differentiation of mesenchymal stem cells is increased as indicated by the overexpression of adipocyte differentiation markers, including peroxisome proliferator-activated receptor (PPAR)-g, adipocyte fatty acid binding protein (aP2), adipsin and resistin.
A decrease in neovascularization may further aggravate bone loss.
(5)Bone quality is also reduced as a result of advanced glycation end products (AGE) production, which may eventually result in low impact or fragility fractures.
DM are associated osteoporosis/fracture.
The underlying mechanism, especially of type 2 DM, mandates a DM-osteoporosis cohort to elucidate.
In clinical practice, to developed preventive strategies from osteoporotic-fracture is also necessary.
Study Overview
Status
Unknown
Conditions
Detailed Description
It is becoming apparent that both type 1 and type 2 diabetes mellitus are associated with an increased risk for osteoporosis-associated fractures.
A meta-analysis by Vestergaard showed that patients with type 1 DM have decreased bone mineral density and increased fracture risk.
This study noted a 6.9 relative risk of hip fracture, when the expected relative risk of fracture was only 1.4 based on the BMD.
This finding suggests that the increased fracture risk is not entirely accounted for by the lower BMD.
It has been demonstrated that the presence of diabetic microvascular complications, including ophthalmic, nephropathic, and neurological, lead to a higher risk of hip fracture in patients with type 1 DM.
Unlike patients with type 1 DM, patients with type 2 DM have an average or higher BMD than age-matched controls.
However, several studies have demonstrated that patients with type 2 DM have a higher risk of hip, proximal humerus, and foot fractures.
Data from the Women's Health Initiative Observational Study indicate that post-menopausal women with diabetes are at an increased risk of hip, foot, and spine fractures, and fractures overall.
For a given BMD, diabetic bone appears to be less strong and therefore more likely to fracture.
Insulin-like growth factor (IGF)-1, insulin, bone morphogenetic proteins and osteoprotegerin (OPG), serve as anabolic signals to promote bone formation.
Among these anabolic mediators, liver-derived IGF-1 is of particular interest since profound growth retardation, small bone size, low BMD and osteoporosis were reported in IGF-1 and IGF-1 receptor deficiencies.
Furthermore, insulin was found to directly induce osteogenic action by increasing cell proliferation, differentiation, alkaline phosphatase activity and expression of type Ⅰcollagen and osteocalcin in human osteoblast-like MG-63 cells.
Type 1 DM featuring low circulating insulin and IGF-1 levels usually occurs in young children prior to peak bone mass attainment, whereas type 2 DM is common in adults who have already attained peak bone mass.
Study Type
Observational
Enrollment (Anticipated)
1200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
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Contact:
- Kuo Chin Huang, PhD
- Phone Number: 66081 886-23123456
- Email: bretthuang@ntu.edu.tw
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
type 2 diabetic patients
Description
- inclusion:40-99 years old with type 2 DM patient
- exclusion:organization people
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Osteoprosis in type 2 diabetic patients- a cohort study
Time Frame: three years
|
three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kuo Chin Huang, PhD, Department of Family Medicine, National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
May 1, 2013
First Submitted That Met QC Criteria
May 2, 2013
First Posted (Estimate)
May 3, 2013
Study Record Updates
Last Update Posted (Estimate)
July 30, 2015
Last Update Submitted That Met QC Criteria
July 28, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201212080RINC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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