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Trial registered on ANZCTR


Registration number
ACTRN12611000955910
Ethics application status
Approved
Date submitted
31/08/2011
Date registered
6/09/2011
Date last updated
6/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A higher response of plasma neuropeptide Y, growth hormone, leptin levels and extracellular glycerol levels in subcutaneous abdominal adipose tissue to Acipimox during exercise in patients with bulimia nervosa: microdialysis study
Scientific title
Antilipolytic drug Acipimox during short-term exercise further increases plasma neuropeptide Y levels in patients with bulimia nervosa compared with healthy women: the role of lipolysis
Secondary ID [1] 262971 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bulimia nervosa 270677 0
Condition category
Condition code
Mental Health 270852 270852 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All subjects were randomised to receive either placebo or Acipimox capsules each week (two 250 mg capsules of the acute-bolus Aci therapy or placebo; 500 mg total - 5- Methylpyrazine-2-carboxylic acid 4-oxide, Olbetam capsules, Farmitalia Carlo Erba, Italy) 500 mg orally 1 hour before a single exercise bout, once a week over a total of 2 weeks. A low- to moderate-intensity exercise bout on an electromagnetically braked bicycle ergometer (Cateye EC 1600, Japan) was performed for 45 min at power output 2 W/kg of lean body mass (LBM). All subjects during 45-min exercise were connected personally with their nurses and attending physicians.
Intervention code [1] 269282 0
Treatment: Drugs
Comparator / control treatment
The placebo was matched to the study drug for taste, color, and size, and contained microcrystalline cellulose, identical in appearance but without the active ingredient.
Control group
Active

Outcomes
Primary outcome [1] 279532 0
A higher overall response of plasma neuropeptide Y, growth hormone and leptin levels to anti-lipolytic drug Acipimox during the exercise in bulimic patients when compared with healthy women. A blood sample was collected at the beginning and in the course (after 45-minute exercise) of the experiment to estimate plasma neuropeptide Y, growth hormone and leptin concentrations. Blood samples were collected into chilled tubes containing Na2EDTA and antilysin. Plasma was separated immediately by centrifugation and stored until being assayed. Plasma neuropeptide Y concentrations were determined by a commercial radioimmunoassay (Linco Research, St. Charles, Missouri, USA). Plasma growth hormone concentrations were measured by a commercial RIA kit (Immunotech, Prague, Czech Republic). Plasma leptin concentrations were determined by a commercial RIA kit (Linco Research, St. Charles, Missouri, USA).
Timepoint [1] 279532 0
at one year after randomisation
Secondary outcome [1] 287854 0
A higher local response of extracellular glycerol in subcutaneous abdominal adipose tissue to Acipimox during the exercise in bulimic patients as well as a higher plasma glycerol turnover as the index systemic lipolysis to Acipimox during the exercise in bulimic patients when compared with healthy women. The in situ and in vivo microdialysis technique (CMA Microdialysis, Stockholm, Sweden) was used to examine the exercise-stimulated lipolysis (by measurement of dialysate glycerol). A blood sample was collected at the beginning and in the course (after 45-minute exercise) of the experiment to estimate plasma glycerol concentrations. Blood samples was collected into chilled tubes containing Na2EDTA. Plasma was separated immediatelly by centrifugation and stored until being assayed. Glycerol in the dialysate and in plasma was analyzed with a radiometric kit (Randox Laboratories, GY 105, Montpellier, France).
Timepoint [1] 287854 0
at one year after randomisation

Eligibility
Key inclusion criteria
age between 18 and 30 years, BMI between 18 and 23 kg/m2, patients with a diagnosis of bulimia nervosa (Diagnostic and Statistical Manual of Mental Disorders, DSM-IV, 1994)
Minimum age
18 Years
Maximum age
30 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
hypertension, abnormal blood tests with significant hyperlipidaemia, history or presence of hepatic or renal disorders
All eligible participants were deemed healthy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3817 0
Czech Republic
State/province [1] 3817 0

Funding & Sponsors
Funding source category [1] 269760 0
Government body
Name [1] 269760 0
The grant No. NR/9158-3 provided by the IGA Grant Agency of the Ministry of Health (2008-2009)
Address [1] 269760 0
Ministry of Health, Palackeho 4, Prague 2, 128 01, Czech Republic
Country [1] 269760 0
Czech Republic
Primary sponsor type
Government body
Name
Ministry of Health
Address
Ministry of Health, Palackeho 4, Prague 2, 128 01, Czech Republic
Country
Czech Republic
Secondary sponsor category [1] 268796 0
Hospital
Name [1] 268796 0
Institute of Endocrinology
Address [1] 268796 0
Narodni 8, Prague 1, 116 94, Czech Republic
Country [1] 268796 0
Czech Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271720 0
Ethics Committee of the Institute of Endocrinology
Ethics committee address [1] 271720 0
Institute of Endocrinology, Narodni 8, 116 94 Prague 1
Ethics committee country [1] 271720 0
Czech Republic
Date submitted for ethics approval [1] 271720 0
07/11/2007
Approval date [1] 271720 0
03/01/2008
Ethics approval number [1] 271720 0
HREC 9158-3

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33081 0
Address 33081 0
Country 33081 0
Phone 33081 0
Fax 33081 0
Email 33081 0
Contact person for public queries
Name 16328 0
Dr. Jara Nedvidkova, Ph.D.
Address 16328 0
Institute of Endocrinology, Narodni 8, Prague 1, 116 94 , Czech Republic, Phone: +420224905272
Fax: +420224905325
Country 16328 0
Czech Republic
Phone 16328 0
+420224905272
Fax 16328 0
Email 16328 0
jnedvidkova@endo.cz
Contact person for scientific queries
Name 7256 0
Dr. Jara Nedvidkova, Ph.D.
Address 7256 0
Institute of Endocrinology, Narodni 8, Prague 1, 116 94 , Czech Republic, Phone: +420224905272
Fax: +420224905325
Country 7256 0
Czech Republic
Phone 7256 0
+420224905272
Fax 7256 0
Email 7256 0
jnedvidkova@endo.cz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary