UMIN-CTR Clinical Trial

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
Email	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
Email	mikisuke@toneyama.go.jp

Sponsor
Institute	National Hospital Organization Toneyama National Hospital
Institute
Department

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
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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017686