UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of carnitine for intermittent claudication of peripheral arterial disease patient with sarcopenia and carnitine deficiency
Title of the study (Brief title)	The effect of carnitine for intermittent claudication of peripheral arterial disease patient with sarcopenia and carnitine deficiency
Region	Japan

Condition
Condition	Peripheral arterial disease(PAD), Arteriosclerosis obliterans(ASO)
Classification by specialty	Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the proportion of sarcopenia in PAD patients, and the effect of carnitine for intermittent claudication of peripheral arterial disease patient with sarcopenia and carnitine deficiency
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pretreatment of carnitine: cross-sectional areas of skeletal muscle at the thigh and lumbar part, serum carnitine level, absolute claudication distance, symptom, ABI Post treatment of carnitine: serum carnitine level, absolute claudication distance, symptom, cross-sectional areas of skeletal muscle at the thigh and lumbar part at 6 months after carnitine treatment
Key secondary outcomes	Adverse event, serum carnitine level, absolute claudication distance, symptom at 4 weeks and 3 months after carnitine treatment

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
Interventions/Control_1	carnitine
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) PAD with intermittent claudication 2) PAD patients desiring for medical treatment 3) The patients obtained informed consent 4) The age over 40 years old 5) Insufficiency of treatment with cilostazole or the difficulty of taking the cilostazole due to side effect
Key exclusion criteria	1) Acute limb ischemia 2) Preferred revascularization for symptoms 3) Comorbidity taking precedence of treatment 4) Bleeding disorders 5) Congestive heart failure 6) Drug allergy of cilostazole or carnitine 7) Pregnant female 8) The patient judged inappropriate by the doctor
Target sample size	30

Research contact person
Name of lead principal investigator	Yoshihiko Maehara
Organization	Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
Division name	Department of Surgery and Science
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	0926425466
Email	maehara@surg2.med.kyushu-u.ac.jp

Public contact
Name of contact person	Takuya Matsumoto
Organization	Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
Division name	Department of Surgery and Science
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5466
Homepage URL
Email	takum@surg2.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
Institute
Department

Funding Source
Organization	Kyushu University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 01 Month 26 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 01 Month 20 Day
Anticipated trial start date	2015 Year 01 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 19 Day
Last modified on	2017 Year 07 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018878