Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000309886
Ethics application status
Approved
Date submitted
15/03/2012
Date registered
20/03/2012
Date last updated
20/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Short-term exercise combined with Acipimox administration induces an increase in plasma adrenocorticotropic hormone (ACTH) levels in patients with bulimia nervosa: Single-blind, randomized study
Scientific title
Pharmacological antilipolysis by Acipimox administration during exercise further increases plasma adrenocorticotropin(ACTH) in bulimic patients
Secondary ID [1] 280122 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bulimia nervosa 286045 0
Condition category
Condition code
Mental Health 286237 286237 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants were randomized to receive either placebo or Acipimox (Aci) capsules each week (two 250 mg capsules of Aci or placebo; 500 mg total – 5-methylpyrazine-2-carboxylic acid 4-oxide, molecular weight: 154.1, Olbetam capsules, Farmitalia Carlo Erba, Milan, Italy) 1 hour before a single exercise bout, e.g. two capsules each week for 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 2W/kg of lean body mass (LBM), intended to be below the aerobic-anaerobic threshold. The exercise was performed individually but all participants during the exercise were connected personally with their nurses and attending physicians. Healthy women were also feature in this study. This is a second arm of the study consisting of matched, healthy controls. Healthy women also took the placebo or Aci capsules.
Intervention code [1] 284468 0
Treatment: Drugs
Intervention code [2] 284488 0
Treatment: Other
Comparator / control treatment
The placebo was matched to the study drug for taste, color, and size and contained microcrystalline cellulose, identical in appearance without the active ingredient.
Control group
Active

Outcomes
Primary outcome [1] 286719 0
The exercise with Acipimox administration resulted in plasma adrenocorticotropic hormone (ACTH) (p < 0.001)increase higher in bulimia nervosa (BN) patients and a decrease in the plasma free fatty acid (FFA) levels in both groups. The falling of plasma ACTH (p < 0.01) levels in the post-exercise recovering phase (90-minute) with Acipimox administration is more expressed in BN patients. Baseline plasma ACTH and FFA levels were similar in BN patients and the controls. A blood sample was collected at the beginning (baseline values) and in the course (after 45-minute exercise with Acipimox administration) of the experiment to estimate plasma ACTH and FFA concentrations. Blood samples were collected into chilled polypropylene tubes containing Na2EDTA and antilysin. Plasma was separated immediately by centrifugation at 4 oC and stored at -80 oC until being assayed. Participants started their 45 min exercise alone or exercise after Acipimox administration, assigned randomly 60 minutes before exercise for two consecutive weeks. Plasma ACTH concentrations were measured by a commercial RIA kit (Immunotech, Inc., Prague, Czech Republic). Plasma FFA were estimated colorimetrically with a commercial kit (Randox Laboratories, FA 115, Montpellier, France). All assays were run twice in duplicate.
Timepoint [1] 286719 0
at one year after randomisation
A blood sample was collected at the beginning (baseline values) and in the course (after 45-minute exercise with Acipimox administration) of the experiment to estimate plasma adrenocorticotropic hormone (ACTH) and free fatty acid (FFA) concentrations.
Secondary outcome [1] 296527 0
The exercise induced an increase in plasma ACTH (p < 0.05) and FFA levels decrease in both groups. A blood sample was collected at the beginning (baseline values) and in the course (after 45-minute exercise) of the experiment to estimate plasma ACTH and FFA concentrations. Baseline plasma ACTH and FFA levels were similar in BN patients and the controls. Blood samples were collected into chilled polypropylene tubes containing Na2EDTA and antilysin. Plasma was separated immediately by centrifugation at 4 oC and stored at -80 oC until being assayed. Participants started their 45 min exercise alone or exercise after Acipimox administration, assigned randomly 60 minutes before exercise for two consecutive weeks. Plasma ACTH concentrations were measured by a commercial RIA kit (Immunotech, Inc., Prague, Czech Republic). Plasma FFA were estimated colorimetrically with a commercial kit (Randox Laboratories, FA 115, Montpellier, France). All assays were run twice in duplicate.
Timepoint [1] 296527 0
at one year after randomisation
A blood sample was collected at the beginning (baseline values) and in the course (after 45-minute exercise) of the experiment to estimate plasma adrenocorticotropic hormone (ACTH) and free fatty acid (FFA) concentrations.

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, 4th edition, text revision, American Psychiatric Association, 2000).
Minimum age
18 Years
Maximum age
30 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
hypertension, abnormal blood tests with significant hyperlipidaemia, and 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
8/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment outside Australia
Country [1] 4201 0
Czech Republic
State/province [1] 4201 0
Prague 1

Funding & Sponsors
Funding source category [1] 284887 0
Government body
Name [1] 284887 0
The grant No. NR/9158-3 provided by the IGA Grant Agency of the Ministry of Health (2008-2009)
Country [1] 284887 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] 283767 0
Hospital
Name [1] 283767 0
Institute of Endocrinology
Address [1] 283767 0
Narodni 8, Prague 1, 116 94, Czech Republic
Country [1] 283767 0
Czech Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286884 0
Ethics Committee of the Institute of Endocrinology
Ethics committee address [1] 286884 0
Ethics committee country [1] 286884 0
Czech Republic
Date submitted for ethics approval [1] 286884 0
05/01/2008
Approval date [1] 286884 0
08/01/2008
Ethics approval number [1] 286884 0
HREC 9158-3/2

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

Contacts
Principal investigator
Name 33909 0
Address 33909 0
Country 33909 0
Phone 33909 0
Fax 33909 0
Email 33909 0
Contact person for public queries
Name 17156 0
Dr. Jara Nedvidkova, Ph.D.
Address 17156 0
Institute of Endocrinology, Narodni 8, Prague 1, 116 94, Czech Repuiblic
Country 17156 0
Czech Republic
Phone 17156 0
+420224905272
Fax 17156 0
+420224905325
Email 17156 0
[email protected]
Contact person for scientific queries
Name 8084 0
Dr. Jara Nedvidkova, Ph.D.
Address 8084 0
Institute of Endocrinology, Narodni 8, Prague 1, 116 94, Czech Repuiblic
Country 8084 0
Czech Republic
Phone 8084 0
+420224905272
Fax 8084 0
Email 8084 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseShort-term exercise combined with Acipimox administration induces an increase in plasma ACTH and its subsequent fall in the recovery phase in bulimic women.2013https://dx.doi.org/10.1016/j.regpep.2012.12.010
N.B. These documents automatically identified may not have been verified by the study sponsor.