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

Bulimia Nervosa Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03338387
• Other study ID #: AZV Grant Agency
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: May 6, 2003
• Est. completion date: December 20, 2023

Study information

• Verified date: September 2023
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: December 20, 2023
• Est. primary completion date: December 16, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Bulimia
• Bulimia Nervosa
• Eating Disorder
• Feeding and Eating Disorders

Intervention

Drug:
• Acipimox
Acipimox
• Placebo
Placebo Other Names: Placebo (for Olbetam)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	baseline and over a total 2 weeks
Primary	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	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.	baseline and over a total 2 weeks