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Enrolling by invitationNCT03338387Updated Feb 19, 2025

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

A Phase 2 interventional study of Acipimox and Placebo in Eating Disorder and Bulimia Nervosa, sponsored by Charles University, Czech Republic. Enrolling by invitation. Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-19.

Sponsored by Charles University, Czech Republic · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Eating Disorder
  • Bulimia Nervosa

Keywords

  • neuropeptides
  • microdialysis
03

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients with a diagnosis of bulimia nervosa
  • Body mass index (BMI) between 18 and 23 kg/m2

Exclusion criteria

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Acipimox

    Other Names: Olbetam

    Drug: Acipimox

  • Placebo comparator
    Placebo

    Other Names: Placebo (for Olbetam)

    Drug: Placebo

Interventions

  • DrugAcipimox

    Acipimox

    Also known as: 5-methylpyrazine-2-carboxylic acid 4-oxide

  • DrugPlacebo

    Placebo Other Names: Placebo (for Olbetam)

    Also known as: Cellulose pills manufactured to mimic Acipimox 250Mg Capsule

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline and over a total 2 weeks

Secondary outcomes

  1. 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.

    Time frame: baseline and over a total 2 weeks

Other outcomes

  1. Changes in body mass index (BMI)

    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

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 21237212 ↗
  • 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. PubMed 22093818 ↗
  • 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. PubMed 23318497 ↗
  • 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. PubMed 24106499 ↗
  • 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. PubMed 26093665 ↗
  • 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. PubMed 30915029 ↗
  • 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. PubMed 30952533 ↗
  • 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. PubMed 33953692 ↗
  • 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. PubMed 33779487 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03338387
Lead sponsor
Charles University, Czech Republic
Responsible party
Kvido Smitka (M.D., Ph.D., Charles University, Czech Republic) — Principal investigator
First posted
Nov 9, 2017
Start date
May 6, 2003
Primary completion
Dec 16, 2007
Completion
Dec 20, 2026 (estimated)
Last update
Feb 19, 2025

Study contacts

Kvido Smitka, M.D., Ph.D.
principal investigator · Charles University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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