Co-Feedback Action of Growth Hormone, PP and PYY on Ghrelin in Bulimia
Primary Purpose
Eating Disorder, Bulimia Nervosa
Status
Enrolling by invitation
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Acipimox
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Eating Disorder focused on measuring neuropeptides, microdialysis
Eligibility Criteria
Inclusion Criteria:
- Patients with a diagnosis of bulimia nervosa
- Body mass index (BMI) between 18 and 23 kg/m2
Exclusion Criteria:
- History of heart disease
- History of bleeding disorders
- Subjects with diabetes type 1 or 2, hypo- or hyperthyroidism
- Subjects with hepatogastroenteric disease
- Pregnant, trying to become pregnant or breast feeding
- Patients with other psychiatric diseases
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Acipimox
Placebo
Arm Description
Other Names: Olbetam
Other Names: Placebo (for Olbetam)
Outcomes
Primary Outcome Measures
Changes in plasma growth hormone levels
Plasma growth hormone (mIU/L) levels will be measured by a commercial RIA kit in the morning and after exercise alone or together with Acipimox administration over a total of 2 weeks.
Secondary Outcome Measures
Changes in extracellular adipose tissue glycerol levels
Extracellular adipose tissue glycerol (umol/L) levels will be measured using microdialysis technique and analyzed with a radiometric kit in the morning and after exercise alone or together with Acipimox administration over a total of 2 weeks.
Full Information
NCT ID
NCT03338387
First Posted
October 6, 2017
Last Updated
September 1, 2023
Sponsor
Charles University, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT03338387
Brief Title
Co-Feedback Action of Growth Hormone, PP and PYY on Ghrelin in Bulimia
Official Title
Acipimox Administration Together With Short-Term Exercise Exerts A Co-Feedback of Growth Hormone, Pancreatic Polypeptide, Peptide YY and Leptin on Ghrelin in Young Bulimic Czech Women: A Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 6, 2003 (Actual)
Primary Completion Date
December 16, 2007 (Actual)
Study Completion Date
December 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the addition of Acipimox or placebo to exercise on growth hormone release and ghrelin secretion in bulimic patients and in healthy women. Two groups of participants will receive Acipimox together with exercise versus identical placebo with exercise.
Detailed Description
Acipimox and exercise each increase growth hormone release, but they do so by different mechanisms.
Acipimox is an anti-lipolytic drug and increases growth hormone release by decreasing free fatty acids levels and that Acipimox may exert to a negative feedback of growth hormone on ghrelin.
Physical exercise is a potent physiological stimulus for growth hormone release. As ghrelin has a stimulatory effect on growth hormone secretion, growth hormone may inhibit circulating ghrelin levels via a feedback loop. Growth hormone stimulates lipolysis and resultant free fatty acids may suppress ghrelin secretion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder, Bulimia Nervosa
Keywords
neuropeptides, microdialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acipimox
Arm Type
Experimental
Arm Description
Other Names: Olbetam
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Other Names:
Placebo (for Olbetam)
Intervention Type
Drug
Intervention Name(s)
Acipimox
Other Intervention Name(s)
5-methylpyrazine-2-carboxylic acid 4-oxide
Intervention Description
Acipimox
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Cellulose pills manufactured to mimic Acipimox 250Mg Capsule
Intervention Description
Placebo Other Names: Placebo (for Olbetam)
Primary Outcome Measure Information:
Title
Changes in plasma growth hormone levels
Description
Plasma growth hormone (mIU/L) levels will be measured by a commercial RIA kit in the morning and after exercise alone or together with Acipimox administration over a total of 2 weeks.
Time Frame
baseline and over a total 2 weeks
Secondary Outcome Measure Information:
Title
Changes in extracellular adipose tissue glycerol levels
Description
Extracellular adipose tissue glycerol (umol/L) levels will be measured using microdialysis technique and analyzed with a radiometric kit in the morning and after exercise alone or together with Acipimox administration over a total of 2 weeks.
Time Frame
baseline and over a total 2 weeks
Other Pre-specified Outcome Measures:
Title
Changes in body mass index (BMI)
Description
Weight in kilograms and height in meters will be measured in the morning and after exercise alone or together with Acipimox administration over a total of 2 weeks. Weight and height will be combined to report BMI in kg/m2.
Time Frame
baseline and over a total 2 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with a diagnosis of bulimia nervosa
Body mass index (BMI) between 18 and 23 kg/m2
Exclusion Criteria:
History of heart disease
History of bleeding disorders
Subjects with diabetes type 1 or 2, hypo- or hyperthyroidism
Subjects with hepatogastroenteric disease
Pregnant, trying to become pregnant or breast feeding
Patients with other psychiatric diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kvido Smitka, M.D., Ph.D.
Organizational Affiliation
Charles University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21237212
Citation
Nedvidkova J, Smitka K, Papezova H, Vondra K, Hill M, Hainer V. Acipimox during exercise points to an inhibitory feedback of GH on ghrelin secretion in bulimic and healthy women. Regul Pept. 2011 Feb 25;167(1):134-9. doi: 10.1016/j.regpep.2010.12.012. Epub 2011 Jan 13.
Results Reference
background
PubMed Identifier
22093818
Citation
Smitka K, Papezova H, Vondra K, Hill M, Hainer V, Nedvidkova J. 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: single-blind, randomized, microdialysis study. Nutr Metab (Lond). 2011 Nov 17;8(1):81. doi: 10.1186/1743-7075-8-81.
Results Reference
background
PubMed Identifier
23318497
Citation
Smitka K, Papezova H, Vondra K, Hill M, Hainer V, Nedvidkova J. Short-term exercise combined with Acipimox administration induces an increase in plasma ACTH and its subsequent fall in the recovery phase in bulimic women. Regul Pept. 2013 Mar 10;182:45-52. doi: 10.1016/j.regpep.2012.12.010. Epub 2013 Jan 11.
Results Reference
background
PubMed Identifier
24106499
Citation
Smitka K, Papezova H, Vondra K, Hill M, Hainer V, Nedvidkova J. The role of "mixed" orexigenic and anorexigenic signals and autoantibodies reacting with appetite-regulating neuropeptides and peptides of the adipose tissue-gut-brain axis: relevance to food intake and nutritional status in patients with anorexia nervosa and bulimia nervosa. Int J Endocrinol. 2013;2013:483145. doi: 10.1155/2013/483145. Epub 2013 Sep 9.
Results Reference
background
PubMed Identifier
26093665
Citation
Smitka K, Maresova D. Adipose Tissue as an Endocrine Organ: An Update on Pro-inflammatory and Anti-inflammatory Microenvironment. Prague Med Rep. 2015;116(2):87-111. doi: 10.14712/23362936.2015.49.
Results Reference
background
PubMed Identifier
30915029
Citation
Smitka K, Nedvidkova J, Vondra K, Hill M, Papezova H, Hainer V. Acipimox Administration With Exercise Induces a Co-feedback Action of the GH, PP, and PYY on Ghrelin Associated With a Reduction of Peripheral Lipolysis in Bulimic and Healthy-Weight Czech Women: A Randomized Study. Front Endocrinol (Lausanne). 2019 Mar 12;10:108. doi: 10.3389/fendo.2019.00108. eCollection 2019.
Results Reference
background
PubMed Identifier
30952533
Citation
Roubalova R, Prochazkova P, Papezova H, Smitka K, Bilej M, Tlaskalova-Hogenova H. Anorexia nervosa: Gut microbiota-immune-brain interactions. Clin Nutr. 2020 Mar;39(3):676-684. doi: 10.1016/j.clnu.2019.03.023. Epub 2019 Mar 23.
Results Reference
background
PubMed Identifier
33953692
Citation
Smitka K, Prochazkova P, Roubalova R, Dvorak J, Papezova H, Hill M, Pokorny J, Kittnar O, Bilej M, Tlaskalova-Hogenova H. Current Aspects of the Role of Autoantibodies Directed Against Appetite-Regulating Hormones and the Gut Microbiome in Eating Disorders. Front Endocrinol (Lausanne). 2021 Apr 19;12:613983. doi: 10.3389/fendo.2021.613983. eCollection 2021.
Results Reference
background
PubMed Identifier
33779487
Citation
Prochazkova P, Roubalova R, Dvorak J, Kreisinger J, Hill M, Tlaskalova-Hogenova H, Tomasova P, Pelantova H, Cermakova M, Kuzma M, Bulant J, Bilej M, Smitka K, Lambertova A, Holanova P, Papezova H. The intestinal microbiota and metabolites in patients with anorexia nervosa. Gut Microbes. 2021 Jan-Dec;13(1):1-25. doi: 10.1080/19490976.2021.1902771.
Results Reference
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Co-Feedback Action of Growth Hormone, PP and PYY on Ghrelin in Bulimia
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