UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025767 |
|---|---|
| Receipt number | R000029642 |
| Scientific Title | The study for association between circulating angiopoetin like protein 2 (ANGPTL2) and various markers related to diabetes in patients with type 2 diabetes |
| Date of disclosure of the study information | 2017/01/22 |
| Last modified on | 2022/01/24 18:41:09 |
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Basic information
Public title
The study for association between circulating angiopoetin like protein 2 (ANGPTL2) and various markers related to diabetes in patients with type 2 diabetes
Acronym
Association between circulating ANGPTL2 and various markers related to DM in T2DM patients
Scientific Title
The study for association between circulating angiopoetin like protein 2 (ANGPTL2) and various markers related to diabetes in patients with type 2 diabetes
Scientific Title:Acronym
Association between circulating ANGPTL2 and various markers related to DM in T2DM patients
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between ANGPTL2 and various markers related to type 2 diabetes or atherosclerosis or between ANGPTL2 and degrees of progression of diabetic complications by cross-sectional analysis
Basic objectives2
Others
Basic objectives -Others
The association between ANGPTL2 and other bloods markers excluding Narrative objectives1
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between ANGPTL2 and various markers related to type 2 diabetes or atherosclerosis or between ANGPTL2 and degrees of progression of diabetic complications (cross-sectional)
Key secondary outcomes
None
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) patients (male or femal) aged 20 or over at enrollment
2) patients diagnosed as type 2 diabetes (based on criteria in Japan Diabetes Society 2010)
3)Patients who are hospitalized for glycemic control for type 2 diabetes
4)patients giving consent in writing for participation for this study
Key exclusion criteria
1)Patients with type 1 diabetes, pancreatic diabetes or secondary diabetes (Cushing syndrome, acromegaly etc.) diabetic coma or diabetic pre-coma, or type 1 diabetes
2)Patients under pregnancy, possible pregnancy, or lactation
3)Furthermore, patients judged as inadequacy for participation in this study by medical doctor
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kohzo |
| Middle name | |
| Last name | Takebayashi |
Organization
Dokkyo Medical University Koshigaya Hospital
Division name
Internal Medicine (Diabetes, Endocrinology, Hematology)
Zip code
343-85555
Address
2-1-50 Minamikoshigaya, Koshigaya, Saitama, Japan
TEL
048-965-1111
takebaya@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Kohzo T |
| Middle name | |
| Last name | Takebayashi |
Organization
Dokkyo Medical University Koshigaya Hospital
Division name
Internal Medicine (Diabetes, Endocrinology, Hematology)
Zip code
343-8555
Address
2-1-50 Minamikoshigaya, Koshigaya, Saitama, Japan
TEL
048-965-1111
Homepage URL
takebaya@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Koshigaya Hospital
Institute
Department
Personal name
Funding Source
Organization
None (Self funding)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University Koshigaya Hospital
Address
2-1-50 Minamikoshigaya, Koshigaya, Saitama, Japan
Tel
0489651111
takebaya@dokkyomed.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
| 2017 | Year | 01 | Month | 22 | Day |
Related information
URL releasing protocol
https://journals.sagepub.com/doi/10.1177/0300060518791067
Publication of results
Unpublished
Result
URL related to results and publications
https://journals.sagepub.com/doi/10.1177/0300060518791067
Number of participants that the trial has enrolled
70
Results
The serum levels of ANGPTL2 were significantly elevated in the type 2 diabetic patients compared with that in the healthy controls. There was a significant positive correlation between ANGPTL2 and either high sensitivity C reactive protein, fibrinogen, or LAB levels, and a significant negative correlation between ANGPTL2 and estimated glomerular filtration rate (eGFR) levels.
Results date posted
| 2022 | Year | 01 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age 60(48.3, 72.8)year
Mean duration of diabetes 7(2, 11.8)year
BMI (kg/m2) 24.5 plus/minus 4.5
FPG (mg/dL)174(143.3, 257.8) mg/dl
HbA1c (%) 9.8(8.8, 11.7)
eGFR (ml/min/1.73 m2) 79.7 (64.2, 96.1)
Participant flow
A total of 70 hospitalized type 2 diabetic patients were prospectively and consecutively enrolled from February 2017 and to August 2017.
Adverse events
Not applicable
Outcome measures
Circulating ANGPTL2
PG , HbA1c
Diabetic complications
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2017 | Year | 01 | Month | 20 | Day |
Last modified on
| 2022 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029642
