UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015222 |
|---|---|
| Receipt number | R000017686 |
| Scientific Title | Phase II clinical trial of combination therapy with medium-chain triglycerides and ghrelin in patients with chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2021/09/27 17:13:35 |
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Basic information
Public title
Phase II clinical trial of combination therapy with medium-chain triglycerides and ghrelin in patients with chronic obstructive pulmonary disease
Acronym
Therapy with medium-chain triglycerides and ghrelin for chronic obstructive pulmonary disease
Scientific Title
Phase II clinical trial of combination therapy with medium-chain triglycerides and ghrelin in patients with chronic obstructive pulmonary disease
Scientific Title:Acronym
Therapy with medium-chain triglycerides and ghrelin for chronic obstructive pulmonary disease
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this phase II clinical trial, underweight patients with COPD will receive 5-day treatment with medium-chain triglycerides (MCT) followed by 3-week combination treatment with MCT and ghrelin. The purpose of the present study is to investigate: i) whether the addition of ghrelin to treatment with medium-chain triglycerides (MCT) would be beneficial; and ii) the safety and effects of 3-week combination treatment on exercise capacity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
1) Peak oxygen uptake
2) SGRQ score
Key secondary outcomes
1) Plasma VEGF level
2) O2-pulse
3) VD/VT
4) VE/Vo2
5) VE/Vco2
6) Respiratory muscle strength
7) Plasma norepinephrine level
8) Body weight
9) CAT score
10) MRC dyspnea scale
11) Six-minute walk distance
12) Food intake
13) Circadian change of plasma active ghrelin level
14) Fatty acids fraction
15) Time course of serum growth hormone level
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
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
1) Administration of edible oil consisting of medium-chain C8 triglyceride (octanoic acid)
<The administration schedule of edible oil>
5 g of edible oil consisting of medium-chain C8 triglyceride will be administered orally, twice daily, for 26 days (at breakfast and at lunch).
2) Administration of ghrelin
<The administration schedule of synthetic human ghrelin>
5-day treatment with medium-chain triglyceride (MCT) followed by 3-week combination treatment with MCT and synthetic human ghrelin will be performed. Synthetic human ghrelin (2 micro-gram/kg, dissolved in 10 mL of sterile saline) will be administered intravenously for 30 minutes and repeated twice daily (before breakfast and before lunch).
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with sever to very severe COPD (FEV1% < 70%, and %FEV1 < 50%)
2) Underweight patients (BMI < 21 kg/m2)
3) Patients whose conditions are stable and who are able to tolerate cardiopulmonary exercise testing to ensure adequate evaluation
4) Patients who have signed the agreement for participation in this study
Key exclusion criteria
1) Patients with malignant tumors
2) Patients with active infection
3) Patients with severe heart disease
4) Patients with hepatic failure (serum levels of AST and ALT greater than twice the normal upper limits)
5) Patients with renal failure (serum creatinine concentration >= 2.0 mg/dL)
6) Patients with asthma or who tested positive on an airway reversibility test
7) Patients who are or could be pregnant
8) Patients who are undergoing diabetes mellitus therapy or whose HbA1C>7.0
9) Patients whose drug regimen was changed within one month before participation in this study
10) In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Miki |
Organization
National Hospital Organization Toneyama National Hospital
Division name
Laboratory Chief, Laboratory of Respiratory Science, Division of Clinical Research
Zip code
Address
5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan
TEL
06-6853-2001
mikisuke@toneyama.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Miki |
Organization
National Hospital Organization Toneyama National Hospital
Division name
Laboratory Chief, Laboratory of Respiratory Science, Division of Clinical Research
Zip code
Address
5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan
TEL
06-6853-2001
Homepage URL
mikisuke@toneyama.go.jp
Sponsor or person
Institute
National Hospital Organization Toneyama National Hospital
Institute
Department
Personal name
Funding Source
Organization
Intramural Research Fund (25-3-1) for Cardiovascular Diseases of National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Grant-in-Aid for Clinical Research from National Hospital Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | 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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 22 | Day |
Last modified on
| 2021 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017686
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| Registered date | File name |
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