Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001209886
Ethics application status
Approved
Date submitted
6/11/2012
Date registered
15/11/2012
Date last updated
6/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of Fatty Acid/Carnitine Homeostasis in Patients with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)
Scientific title
Assessment of Fatty Acid/Carnitine Homeostasis in Patients with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)
Secondary ID [1] 281504 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Fatigue Syndrome/Myalgic Encephalomyelitis 287774 0
Condition category
Condition code
Other 288122 288122 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study of fatty acid/carnitine homeostasis in CFS/ME. Participants will provide a single fasting blood sample from which plasma free fatty acid and carnitine levels will be determined and the ratio of fatty acid/carnitine levels calculated. In a sub-group of participants, assessment will also be conducted using standard 13C-oleic acid breath testing and baseline corrected expired air 13CO2 concentration-time data will be kinetically modelled to determine the rate and extent of fatty acid oxidation.
Intervention code [1] 286019 0
Not applicable
Comparator / control treatment
Assessment of fatty acid/carnitine homeostasis in a sub-group of healthy controls
Control group
Active

Outcomes
Primary outcome [1] 288326 0
The primary objective of this study is to determine the ratio of free fatty acid/acylcarnitine for a wide range of fatty acids, as an index of fatty acid/carnitine homeostasis, in patients with CFS/ME compared to healthy controls, and the possible application of this information as a diagnostic criterion in CFS/ME.
Participants will provide a single fasting blood sample from which plasma free fatty acid and carnitine levels will be determined and the ratio of fatty acid/carnitine levels calculated. Ratios will be compared between the study populations using an analysis of variance (ANOVA) to determine if a difference exists.
Timepoint [1] 288326 0
Single-point assessment
Primary outcome [2] 288373 0
The relationship between the ratio of fatty acid/carnitine levels and quality-of-life (assessed via Medical Outcomes Study Short-Form 36 questionnaire) and fatigue severity (assessed via Fatigue Severity Scale) will be examined using linear regression.
Timepoint [2] 288373 0
Single-point assessment
Secondary outcome [1] 299859 0
The secondary objective of this study is to determine the rate and extent of fatty acid oxidation, as indicated by the 13C fatty acid breath test, in patients with CFS/ME compared to healthy controls, and to assess the suitability of this test for the clinical diagnosis of CFS/ME.
In a sub-group of participants, assessment will also be conducted using standard 13C-oleic acid breath testing and baseline corrected expired air 13CO2 concentration-time data will be kinetically modelled to determine the rate and extent of fatty acid oxidation. Breath test results will be compared between the study populations using an analysis of variance (ANOVA) to determine if a difference exists.
Timepoint [1] 299859 0
Single-point assessment
Secondary outcome [2] 299993 0
The relationship between breath test results and quality-of-life (assessed via Medical Outcomes Study Short-Form 36 questionnaire) and fatigue severity (assessed via Fatigue Severity Scale) will be examined using linear regression.
Timepoint [2] 299993 0
Single-point assessment

Eligibility
Key inclusion criteria
1. Participant is >=18 years of age at the time of informed consent.
2. Participant is a male or non-pregnant, non-lactating female.
3. Participant is either:
i. a patient diagnosed with CFS/ME by a physician according to the standard diagnostic criteria; or
ii. a healthy subject with no clinically significant conditions.
4. Participant is aware of the study procedures and the risks involved and voluntarily agrees to participate by providing written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participant has received treatment with L-carnitine or any carnitine derivatives within 2 months of study participation.
2. Participant has received treatment with fatty acid-containing products within 2 months of study participation.
3. Participant has received treatment with a pharmacologic agent known to alter fatty acid/carnitine homeostasis within 2 months of study participation.
4. Participant has a known blood-borne viral infection, including HIV, Hepatitis B or Hepatitis C.
5. Participant has a history or current evidence of any condition, therapy or laboratory abnormality that, in the opinion of the investigator, might affect the results of the study or may not be in the best interest of the individual to participate.
6. Participant has participated in a clinical trial within 2 months of study participation that, in the opinion of the investigator, might affect the results of the study or may not be in the best interest of the individual to participate.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/08/2012
Actual
5/09/2012
Date of last participant enrolment
Anticipated
Actual
1/08/2013
Date of last data collection
Anticipated
Actual
19/08/2013
Sample size
Target
100
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 286285 0
Charities/Societies/Foundations
Name [1] 286285 0
The Judith Jane Mason and Harold Stannett Williams Memorial Foundation
Country [1] 286285 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
CEA-19, GPO Box 2471
Adelaide, SA, 5001
Country
Australia
Secondary sponsor category [1] 285080 0
None
Name [1] 285080 0
Address [1] 285080 0
Country [1] 285080 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288357 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 288357 0
GPO Box 2471
Adelaide, SA, 5001
Ethics committee country [1] 288357 0
Australia
Date submitted for ethics approval [1] 288357 0
09/07/2012
Approval date [1] 288357 0
17/08/2012
Ethics approval number [1] 288357 0
0000030308

Summary
Brief summary
Single fasting blood samples will be collected from each study participant for analysis of endogenous plasma L carnitine, acylcarnitine and free fatty acid concentrations. Results will be utilised for the determination of indices of fatty acid/carnitine homeostasis, calculated as the ratio of plasma free fatty acid – acylcarnitine. At the time of blood sample collection, each study participant will complete validated questionnaires for assessment of fatigue severity (Fatigue Severity Scale) and quality of life (Medical Outcomes Study Short-Form 36, SF 36).
13C oleic acid breath testing will be conducted in a subgroup of participants. After an overnight fast, participants will be administered a single 50 mg oral dose of 13C oleic acid. Expired air samples will be collected prior to dose administration (baseline) and then at hourly intervals until 8 hours post-dose for analysis of 13CO2 content. Baseline-corrected expired air 13CO2 concentration-time data will be kinetically modelled to determine the rate and extent of oxidation of oleic acid.
Results of fatty acid/carnitine profiling and 13C oleic acid breath testing obtained from patients with CFS/ME will be statistically compared to those obtained from healthy controls using analysis of variance (ANOVA). Statistical examination of the relationship between the determined indices of fatty acid oxidation and fatigue severity/quality of life will be conducted using linear regression.
Trial website
Trial related presentations / publications
None.
Public notes

Contacts
Principal investigator
Name 34925 0
Dr Stephanie Reuter Lange
Address 34925 0
University of South Australia
CEA-19, GPO Box 2471
Adelaide SA 5001
Country 34925 0
Australia
Phone 34925 0
+61883021872
Fax 34925 0
Email 34925 0
[email protected]
Contact person for public queries
Name 18172 0
Dr Stephanie Reuter Lange
Address 18172 0
CEA-19, GPO Box 2471
Adelaide, SA, 5001
Country 18172 0
Australia
Phone 18172 0
+61 8 8302 1872
Fax 18172 0
Email 18172 0
[email protected]
Contact person for scientific queries
Name 9100 0
Dr Stephanie Reuter Lange
Address 9100 0
CEA-19, GPO Box 2471
Adelaide, SA, 5001
Country 9100 0
Australia
Phone 9100 0
+61 8 8302 1872
Fax 9100 0
Email 9100 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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