search
Back to results

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
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorder focused on measuring neuropeptides, microdialysis

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    October 6, 2017
    Last Updated
    September 1, 2023
    Sponsor
    Charles University, Czech Republic
    search

    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
    background

    Learn more about this trial

    Co-Feedback Action of Growth Hormone, PP and PYY on Ghrelin in Bulimia

    We'll reach out to this number within 24 hrs