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

NCT03338387 | Enrolling By Invitation Phase 2

• 1 other identifier: AZV Grant Agency
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Eating Disorder; Bulimia Nervosa

Keywords

neuropeptides; microdialysis

Outcome Measures

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.

  baseline and over a total 2 weeks

Secondary Outcomes (1)

• Changes in extracellular adipose tissue glycerol levels

  baseline and over a total 2 weeks

Other Outcomes (1)

• Changes in body mass index (BMI)

  baseline and over a total 2 weeks

Study Arms (2)

Acipimox

EXPERIMENTAL

Other Names: Olbetam

Drug: Acipimox

Placebo

PLACEBO COMPARATOR

Other Names: Placebo (for Olbetam)

Drug: Placebo

Interventions

Acipimox DRUG

Acipimox

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

Acipimox

Placebo DRUG

Placebo Other Names: Placebo (for Olbetam)

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

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Related Publications (9)

• 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.

  PMID: 21237212 BACKGROUND

• 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.

  PMID: 22093818 BACKGROUND

• 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.

  PMID: 23318497 BACKGROUND

• 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.

  PMID: 24106499 BACKGROUND

• 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.

  PMID: 26093665 BACKGROUND

• 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.

  PMID: 30915029 BACKGROUND

• 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.

  PMID: 30952533 BACKGROUND

• 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.

  PMID: 33953692 BACKGROUND

• 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.

  PMID: 33779487 BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders; Bulimia Nervosa

Interventions

acipimox

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Kvido Smitka, M.D., Ph.D.

  Charles University, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: November 9, 2017
• Study Start: May 6, 2003
• Primary Completion: December 16, 2007
• Study Completion (Estimated): December 20, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share