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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006516
Receipt No. 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

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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
Email 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
Email nagai-s@med.hokudai.ac.jp

Sponsor
Institute Department of Medicine II, Hokkaido University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007728

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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