UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031382 |
|---|---|
| Receipt number | R000035763 |
| Scientific Title | pathology research of secondary osteoporosis in adult patients with type 2 diabetes mellitus: bone microarchitecture assessed by HR-pQCT |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2024/03/08 12:03:27 |
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Basic information
Public title
pathology research of secondary osteoporosis in adult patients with type 2 diabetes mellitus: bone microarchitecture assessed by HR-pQCT
Acronym
T2DM HR-pQCT study
Scientific Title
pathology research of secondary osteoporosis in adult patients with type 2 diabetes mellitus: bone microarchitecture assessed by HR-pQCT
Scientific Title:Acronym
T2DM HR-pQCT study
Region
| Japan |
Condition
Condition
type 2 diabete mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate bone microarchitecture assessed by HR-pQCT in adult patients with type 2 diabetes mellitus. And we compare them with healthy subjects.
Basic objectives2
Others
Basic objectives -Others
pathology research
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We investigate bone microarchitecture assessed by HR-pQCT in adult patients with type 2 diabetes mellitus. And we compare them with healthy subjects.
Key secondary outcomes
We compare the relationship between bone microarchitecture and metabolic markers with healthy subjects.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.adult patients of 20 years and over with type 2 diabetes mellitus
2.healthy control
each 120 cases
Key exclusion criteria
1.a patient with type 1 diabetes mellitus
2.a patinet with thyroid disease, parathyroid disease, celiac or inflammatory bowel disease, renal dysfunction(defined as eGFR <30ml/min) or liver dysfunction (AST > 3 times the upper limit of normal)
3.a patient who takes current or past treatment for osteoporosis
4.a patient who takes a drug such as steroid, anticonvulsant, Ca, P, Vitamin D, Vitamin K, multivitamin, or hormone replacement therapy
5.a patient with a malignat tumor
6.a patient who is pregnant, may be pregnant, or breastfeed
7.a patient whose alchohol consumption over 20g/day
8.a smoker
9.a patient who participates another clinical research within 6 months
10.a patient who is determined as inappropriate as a subject for other reasons by investigator
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Erika |
| Middle name | |
| Last name | Aikawa |
Organization
Nagasaki University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
0958197200
erikaaikawa@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Erika |
| Middle name | |
| Last name | Aikawa |
Organization
Nagasaki University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
095-819-7262
Homepage URL
erikaaikawa@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Department of Endocrinology and Metabolism
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
Department of Endocrinology and Metabolism
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken, Japan
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
unexecuted
Management information
Registered date
| 2018 | Year | 02 | Month | 20 | Day |
Last modified on
| 2024 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035763
