UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006516 |
|---|---|
| Receipt number | R000007728 |
| Scientific Title | The effect of incretins to serum growth hormone levels in acromegalic patients during oral and intravenous glucose administration tests. |
| Date of disclosure of the study information | 2011/10/11 |
| Last modified on | 2015/05/11 15:40:54 |
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Basic information
Public title
The effect of incretins to serum growth hormone levels in acromegalic patients during oral and intravenous glucose administration tests.
Acronym
The effect of incretins to growth hormone secretion in acromegalic patients.
Scientific Title
The effect of incretins to serum growth hormone levels in acromegalic patients during oral and intravenous glucose administration tests.
Scientific Title:Acronym
The effect of incretins to growth hormone secretion in acromegalic patients.
Region
| Japan |
Condition
Condition
Acromegaly
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of incretins on oversecretion of growth hormone in acromegalic patients.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of the paradoxical increase of growth hormone in oral glucose tolerance test.
Changes of serum growth hormone levels during intravenous glucose loading test and sitagliptin loading test in the patients with paradoxical growth hormone increase.
Key secondary outcomes
Changes of serum growth hormone levels in pharmacological loading tests in the patients with or without the paradoxical increase.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
With oral administration of sitagliptin, patients take test-meal. Thereafter, blood samples are collected at 0, 15, 30, 60, 90, 120 min.
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
Patients who have been diagnosed as "acromegaly" regardless of treatment status.
Patients who agreed with written consent form, receiving enough information of this study.
Key exclusion criteria
Patients who do not agreed with written consent form.
Patients who have the diseases, which may affect the result of endocrine tests, such as infectious, hepatic, and renal disorders.
Poor controlled diabetic patients, because they are not appropriate for the glucose loading test.
Patients who are inappropriate for this study by research director.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nagai, So |
Organization
Hokkaido University Hospital
Division name
Department of Medicine II
Zip code
Address
N-14, W-5, Kita-Ku, Sapporo, 060-8638, Japan
TEL
011-706-5916
nagai-s@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nagai, So |
Organization
Hokkaido University Hospital
Division name
Department of Medicine II
Zip code
Address
N-14, W-5, Kita-Ku, Sapporo, 060-8638, Japan
TEL
011-706-5916
Homepage URL
http://www.huhp.hokudai.ac.jp/patient/clinical/clinical.html
nagai-s@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Medicine II, Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 11 | 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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 11 | Day |
Last modified on
| 2015 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007728
